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Senior Project Manager jobs at Premier Research - 155 jobs

  • Senior Manager, Order to Cash

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA jobs

    **Job Description****General Summary:**Vertex is seeking an experienced Order to Cash professional to join our Controllership organization as a senior manager within the Global Revenue Accounting team. The Controllership organization is integral in delivering Vertex's mission of creating transformative medicines for people with serious and life-threatening diseases. You will be working as part of a dynamic and diverse organization alongside outstanding people who are forward-thinking, collaborative and recognized leaders in their areas.The position is a key role within Global Revenue Accounting, and we are seeking an experienced and strategic Senior Manager within Order to Cash “O2C” to manage our credit control function, drive cash flow optimization, manage internal controls and implement solutions that strengthen financial performance. The successful candidate will combine hands-on credit control expertise with strategic insight, leading a team of two to maximize collections, minimize risk, and support business growth.Central to this role is fostering exceptional working relationships across the Controllership function, Global Supply Chain, our third-party logistics providers, and regional finance teams. The individual will also be well organised, comfortable presenting and influencing senior stakeholders and able to manage competing deadlines.This role is highly visible across the international organisation and with our global head office in Boston and offers excellent opportunities for personal development and continuous improvement. As Vertex continues to grow, and expand geographically, the successful candidate will have many opportunities to shape processes and drive lasting change.**Key Duties and Responsibilities:*** Work with global finance, revenue accounting, trade ops, supply chain and market access teams to ensure we remain at the forefront of any changes to our ways of working* Implement and enforce credit policies and procedures that mitigate risk while supporting customer relationships* Present credit & collections updates to Senior Directors and Departmental Heads* Build strong relationships with our external service providers, internal stakeholders and business partners* Represent the team at Global Credit Committee meetings, interacting with the Global Finance and Chief Accounting Officer's leadership team* Develop and execute credit strategies that optimize cash flow, reduce Days Sales Outstanding (DSO), and minimize bad debt* Protect Vertex's credit risk with consideration for securitisation initiatives.* Design process solutions in support of key business decisions and new product/country launches* Drive improvements in our monthly Dashboard reporting* Drive transformation initiatives (system/process/policy)* Participate in global projects representing the needs and interests of the O2C and wider Revenue Accounting team* Analyse the performance of external service providers against KPIs* Ensure our ongoing compliance to all O2C related SOX controls**Knowledge and Skills:*** Ability to work collaboratively with external service providers, to ensure the highest standards of execution are maintained and the interests of Vertex and its patient remain forefront* Strong stakeholder management skills, able to quickly establish credibility and build effective, collaborative, working relationships at all levels* Excellent communication and interpersonal skills necessary for leading cross functional projects and presenting to senior management (including accounting, finance and commercial management)* Ability to partner with other functional areas to develop, improve and monitor compliance with policies and procedures including taking a leadership role on certain initiatives* Strong financial analysis and reporting skills* Strong knowledge of credit control, risk management, and regulatory compliance* Strategic thinker with ability to provide solutions to cash flow and credit challenges* People management skills, with experience motivating and developing teams* Solution-focused with experience in improving processes and systems* Ability to pivot based on demand and prioritization**Education and Experience:*** Bachelor's Degree in Accounting or Business administration, or equivalent business experience* Strong credit control/accounts receivable experience, in a managerial or leadership role* Experience in large, complex, or multinational organizations preferred* Experience in pharmaceutical industry preferred#LI-SG1#LI-Hybrid**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com #J-18808-Ljbffr
    $131k-172k yearly est. 19h ago
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  • Manager, Project Management

    Eclinical Solutions 4.4company rating

    Mansfield, MA jobs

    eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions. You will make an impact: The Manager, Project Management, is responsible for overseeing a team of Project Management professionals and driving operational excellence across the Biometrics Services which include EDC, data management and biostatistics. This role provides leadership for high-profile and strategically important client engagements, ensuring delivery of complex clinical trial initiatives in compliance with regulatory requirements, industry best practices, and eClinical Solutions (eCS) internal standards. The Manager, Project Management partners closely with other Biometrics Services leaders, cross organizational leaders and delivery teams to ensure successful execution across the full clinical trial lifecycle-from study startup through database lock and regulatory submission support. This role is accountable for delivery quality, timeline adherence, client satisfaction, and repeat business, while fostering a culture of accountability, continuous improvement, and operational rigor. Your day to day: Monitor, mentor, and audit the performance of direct reports to ensure adherence to PMI-compliant project management practices and eCS standards Coach PMs to balance aggressive delivery goals with realistic execution plans, especially in regulated clinical environments Lead and oversee complex clinical trial projects, ensuring delivery aligns with protocol requirements, client expectations, and regulatory standards Ensure project plans account for interdependencies across EDC, IRT, CROs, sponsors, biostatistics, and data review workflows Proactively identify and manage risks related to data quality, timelines, resourcing, and external vendor dependencies Drive disciplined study start-up planning, including realistic timelines, cross-functional alignment, and clear accountability Integrate lessons learned from completed studies to improve future delivery models and client engagements Support leadership with strategic initiatives related to scaling the Biometrics Services organization Serve as the customer success champion for assigned clinical trial clients, ensuring consistent communication, transparency, and proactive issue management Build trusted partnerships with sponsors by setting up and reinforcing shared accountability for timelines and deliverables Other duties as assigned Take the first step towards your dream career. Here is what we are looking for in this role. Qualifications: Bachelor's degree or equivalent work experience preferred Project Management Professional (PMP) certification preferred 10+ years of project management experience preferably in a clinical, biomedical, or software environment preferred 5+ years in Pharmaceutical/Biotechnology industry or equivalent senior consulting role managing large complex clients/multiple projects preferred 3+ years of people leadership preferred Exceptional communication, negotiation, and stakeholder management skills Strategic thinker with the ability to translate vision into operational execution Proven ability to manage ambiguity and high-pressure client environments Deep commitment to deliver quality, client success, and organizational integrity Expert with Microsoft applications (Word, Outlook, Excel, PowerPoint, Project, Visio, Teams, etc.), collaborative platforms (MS Teams, OneDrive, SharePoint, etc.) and operational tools (billing systems, HR systems, payroll systems, etc.) Highly experienced and successful in managing complex data management/clinical trial projects and programs in accordance with PMI and industry best practices, methodologies, principles and tools Strong working knowledge of: ICH/GCP guidelines, 21 CFR Part 11, Clinical trial methodologies and lifecycle, CRO and IRT vendor models and EDC platforms (e.g., Medidata Rave) eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: ****************************************************** eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. Pay Range US Pay Ranges $160,000-$180,000 USD
    $160k-180k yearly Auto-Apply 10d ago
  • Patient Support Business Systems Manager

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA jobs

    The Patient Support Business Systems Manager supports the Kidney Patient Support team by managing the launch and continuous improvement of a new customer relationship management (CRM) system. This is an individual contributor role and a member of the US, Patient Support Center of Excellence (CoE). The Patient Support Business Systems Manager partners deeply with Patient Support, Access & Reimbursement, Training, Quality & Compliance, Field teams, Data & Analytics, and Technology partners to translate business needs into scalable digital workflows, integrations, analytics, and enhancements that improve speed-to-therapy, patient experience, and operational efficiency. This role manages the CRM system and digital engagement tools that patient support specialists use in their day-to-day workflows to engage with patients and HCPs, specifically where processes overlap, and systems are integrated. Key Duties and Responsibilities: Collaborate with business stakeholders to gather and groom functional requirements, then communicate with technical teams to translate items into technical system requirements. Strong background and working knowledge of AI-enabled patient service capabilities to improve access, speed to therapy, and patient/HCP engagement while meeting compliance and data governance standards Build and maintain end to end process flows across patient access and engagement journeys; facilitate functional and technical workshops to document current/future state, surface inefficiencies, and convert opportunities into prioritized backlog items and measurable workflow optimizations. Align and support creation of the annual business project plan and roadmap for Patient Services CRM with clear milestones and dependencies based on the overall vision. Ensure full alignment with Data, Technology and Engineering (DTE) function. Facilitates capability prioritization discussions with PSP team and can speak to their perspective on business priorities. Using strong project management, leadership, and communication skills hold self and PSP team accountable to stay on track with deliverable deadlines for requirements and annual planning. Works closely with DTE Project Manager to oversee end to end sprint management activities and ceremonies. Managing the product backlog, proactively raising issues and constantly conducting prioritization exercises based on changing business requirements within Jira. Participate in the RFP process for tools, technologies, and support with DTE. Provides Implementation support including validation of business requirements and User Acceptance Testing (UAT). Partner with Commercial Training and Change Management teams to ensure necessary supporting materials are provided and training content is consistent with system functionality. Knowledge and Skills: Experience in supporting commercial systems for patient support programs/hub services a plus Demonstrated strong project management, troubleshooting, and problem-solving skills Proven track record of success with strong results and excellent customer relationship skills Expected to be knowledgeable of the CRM system and digital engagement tools with patients/HCPs, understanding where processes and systems overlap and integrate to help drive process efficiencies for patient support specialists Excellent interpersonal, communication, organizational and facilitation skills Proactive, Self-motivated, Independent worker Passion for understanding emerging technologies with pragmatic insight into where those technologies can be integrated into business solutions Able to perform in a fast-paced environment, manage multiple priorities simultaneously, and communicate complex information clearly Education and Experience: Bachelor's degree in computer science, software engineering or other related technology degree. Salesforce certifications 5+ years' relevant experience in life sciences organization or healthcare industry, including experience working with Salesforce platform, Salesforce Life Sciences Cloud / Health Cloud or similar CRM Pay Range: $124,000 - $186,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $124k-186k yearly Auto-Apply 17d ago
  • Steel Project Manager

    SST Direct 4.2company rating

    Fresno, CA jobs

    Job DescriptionWe are seeking a Steel Project Manager for a direct hire, long-term opportunity in Fresno, CA. Overview: Overseeing structural steel projects from fabrication to erection. Projects: Commercial retail and public works Pay: $120-150K, plus a generous yearly discretionary bonus Schedule: Mon-Friday (8 am to 5 pm) Benefits: Vehicle allowance or company-provided vehicle, 401K match at 4%, medical, dental, and vision benefits and more! Travel: Only to the projects in California. Travel to remote job sites may be required; occasional overnight stays depending on project location Relocation: Relocation assistance is available for the ideal candidate Key Responsibilities for Steel Project Manager: Contract Review & Interpretation - Review and interpret contract documents, plans, and specifications. Scheduling - Develop and align project schedules with structural steel fabrication and erection sequences. Relationship Management - Build and maintain relationships with superintendents, managers, erectors, and vendors. Submittals & Documentation - Facilitate, review, and submit project submittals, RFIs, change orders, and invoices. Shop Drawings - Create and review hand shop drawings when required. Field Coordination - Conduct field measurements as needed; develop site-specific erection procedures and plans. Procurement & Job Buyout - Oversee buyouts and coordinate fabrication, delivery, and installation with shop and field personnel. Cost Control - Monitor project budgets, track job costs, and provide timely reports. Software Integration - Utilize Tekla EPM and Procore to manage workflow, costs, and communication. Meetings- Attend job kick-off meetings. Qualifications for Steel Project Manager: 5+ years of relevant experience, with a strong background in structural steel project management. Office experience in the field of Architecture, Engineering, or Construction Preferred Ability to operate common office software programs, including Microsoft Office products (e.g., Word, Excel, Outlook), Adobe Acrobat, Procore, and Construction Partner. Knowledge of office management systems and procedures Excellent time management skills and ability to multitask and prioritize work If you are interested in learning more about this role, please submit your resume for immediate consideration! Powered by JazzHR klx CmIlY44
    $120k-150k yearly 21d ago
  • Steel Project Manager

    SST Direct 4.2company rating

    Fresno, CA jobs

    We are seeking a Steel Project Manager for a direct hire, long-term opportunity in Fresno, CA. Overview: Overseeing structural steel projects from fabrication to erection. Projects: Commercial retail and public works Pay: $120-150K, plus a generous yearly discretionary bonus Schedule: Mon-Friday (8 am to 5 pm) Benefits: Vehicle allowance or company-provided vehicle, 401K match at 4%, medical, dental, and vision benefits and more! Travel: Only to the projects in California. Travel to remote job sites may be required; occasional overnight stays depending on project location Relocation: Relocation assistance is available for the ideal candidate Key Responsibilities for Steel Project Manager: Contract Review & Interpretation - Review and interpret contract documents, plans, and specifications. Scheduling - Develop and align project schedules with structural steel fabrication and erection sequences. Relationship Management - Build and maintain relationships with superintendents, managers, erectors, and vendors. Submittals & Documentation - Facilitate, review, and submit project submittals, RFIs, change orders, and invoices. Shop Drawings - Create and review hand shop drawings when required. Field Coordination - Conduct field measurements as needed; develop site-specific erection procedures and plans. Procurement & Job Buyout - Oversee buyouts and coordinate fabrication, delivery, and installation with shop and field personnel. Cost Control - Monitor project budgets, track job costs, and provide timely reports. Software Integration - Utilize Tekla EPM and Procore to manage workflow, costs, and communication. Meetings- Attend job kick-off meetings. Qualifications for Steel Project Manager: 5+ years of relevant experience, with a strong background in structural steel project management. Office experience in the field of Architecture, Engineering, or Construction Preferred Ability to operate common office software programs, including Microsoft Office products (e.g., Word, Excel, Outlook), Adobe Acrobat, Procore, and Construction Partner. Knowledge of office management systems and procedures Excellent time management skills and ability to multitask and prioritize work If you are interested in learning more about this role, please submit your resume for immediate consideration!
    $120k-150k yearly Auto-Apply 49d ago
  • Project Manager (Clinical Research)

    Celerion 4.2company rating

    Remote

    Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Are you looking for an opportunity to lead projects creating life-saving treatments? If so, we want to meet you! Celerion seeks a full-time, experienced Global Project Manager to join our team. This critical role is accountable for project deliverables and client satisfaction, serving as a consistent point of contact for internal and external clientele from the beginning to the end of the project life cycle. The position requires a high level of leadership, collaboration, and relationship-building to ensure optimal project success. Please note: This role may be located in our Tempe, AZ office, Lincoln, NE office, or based remotely (working from home anywhere in the US ). Essential Functions:Manages multiple clients and their associated projects, fostering relationships with assigned clientele Confirms each project's scope in conjunction with the client and operational teams to ensure adherence to contractual scope, timelines and budget for all team members Engages assigned team and functional managers in the development, assignment and prioritization of work based on the project's needs, taking corrective action with Operations as appropriate to control project scope and cost Fosters high-level of communication by conducting frequent project meetings, initiated at project inception and continuing through project closeout Creates or reviews and maintains project-related documentation including: RFIs, Budgets, Meeting Minutes, Timelines, Client Isms, Issues and Risk Lists, Change Requests, etc.Implements change management where appropriate to alleviate bottlenecks, improving processes and procedures to enhance the efficiency and effectiveness of the organization Updates relevant databases required to maintain and report on current project statuses and overall financial reporting Hosts client visits and conducts facility tours Requirements: Bachelor's degree required (degree emphasis in life science discipline preferred) Requires high-level skills in the areas of organization, multi-tasking, relationship-building, communication, judgment, problem-solving, persuading and negotiating Minimum 2 years of Clinical Research industry experience is highly preferred 3 years Phase I Project Management experience preferred #LI-Remote Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
    $71k-112k yearly est. Auto-Apply 60d+ ago
  • Project Manager I (CRO or Life Sciences) - Remote

    MMS 4.7company rating

    Dundalk, MD jobs

    MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions - rooted in strong science and decades of regulatory experience - that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit ******************* or follow MMS on LinkedIn. This position requires proven Project Management experience in support of Biometric deliverables (Data management, Biostatistics, Statistical Programming services). Job Responsibilities: Understands various cost models and develops budgets for moderate complexity projects. Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects. Controls project scope via defined PM methodology and processes for change management. Develops moderate complexity project timelines independently. Performs advanced functions in MSP. Understands task constraints and conveys critical path milestones to the functional lead. Develops/input into strategies to help achieve timeline expectations. Executes day-to-day activities during the course of a program/project including risk identification, issue escalation and resolution. Collaborates with functional line management to resolve any issues and trends. Drives customer satisfaction and works to strengthen client relationships. Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum). Manages minimum one key account. Participates in or leads bid defenses. Proficient in Word, Outlook, PowerPoint, Excel. Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met. Understands general requirements: ICH, 21CRF Part 11, and ISO 9001:2000. Requirements: Bachelor's Degree required, or relevant work experience. Minimum of 2 years' experience in project coordination or project management or similar field required. Expert knowledge of scientific principles and concepts. Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred. Good communication skills and willingness to work with others to clearly understand needs and solve problems. Excellent problem-solving skills. Good organizational and communication skills. Familiarity with current ISO 9001 and ISO 27001 standards preferred. Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Powered by JazzHR WuGhfcHYtF
    $76k-115k yearly est. 17d ago
  • Regulatory CMC Project Manager

    Parexel 4.5company rating

    Columbus, OH jobs

    If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager** to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed. Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards. Health Authority Engagement: Support the preparation of materials for health authority engagements Qualifications: + Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management). + 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). + Strong project management skills with a track record of managing complex projects and meeting deadlines. + Excellent organizational and communication skills. + Excellent time management abilities + Proficient in Microsoft Office Suite + Proven experience with project management software ie. Smartsheet + Strong communication and interpersonal skills + Ability to work collaboratively in a fast-paced, dynamic environment. Additional Requirements: + Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $69k-101k yearly est. 50d ago
  • Regulatory CMC Project Manager

    Parexel International 4.5company rating

    Remote

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented Regulatory CMC Project Manager to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed. Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards. Health Authority Engagement: Support the preparation of materials for health authority engagements Qualifications: Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management). 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). Strong project management skills with a track record of managing complex projects and meeting deadlines. Excellent organizational and communication skills. Excellent time management abilities Proficient in Microsoft Office Suite Proven experience with project management software ie. Smartsheet Strong communication and interpersonal skills Ability to work collaboratively in a fast-paced, dynamic environment. Additional Requirements: Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones #LI-LB1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
    $78k-119k yearly est. Auto-Apply 24d ago
  • Project Manager

    Precision Medicine Group 4.1company rating

    Remote

    Why PRECISIONeffect? When you love what you do, it won't feel like work. Who says your calling and career have to be mutually exclusive? People who join us at PRECISIONeffect are drawn to our agency because of their passion for and commitment to truly cutting-edge and incredible work - they stay for our ethos of wecentricity, the community and collaboration we foster here. Launching clients' treatments. Changing patients' lives. Advancing creativity and strategy, improving results and outcomes. We do our best and most innovative work when it's fueled by purpose and comprised of the unique and varied perspectives and abilities of Effectors across the globe. At PRECISIONeffect, talent is displayed in the work, not flaunted in plumes of conceit. Here, cooperation and wecentricity are what we champion. Are you a self-effacing rock star? A sensible diva? A down-to-earth maestro? Have we got a stage for you. Our people are wildly talented, clever, and inspiring. Who we are: The Project Management team is the engine that keeps the agency machine running. We are strategic problem solvers and communicators that lead cross-functional teams from planning to project delivery. PM's are the barometer for teams, and collaborate with all departments to ensure work is executed on time and on budget, and partner with Account Teams in strategic planning and workflow. We radiate wecentricity and a constructive approach to all work, with a focus on efficiency and effectiveness. Who you are: Project Managers are a problem solvers who bring a skilled team together to ensure the agency successfully executes and delivers to market, within the agreed time and budget. Essential functions of the job include but are not limited to: Project Planning Reporting to and partnering with the Group Project Manager and/or Sr. Project Managers to: Review high-level client, program/campaign and project plan for the year Obtain a clear understanding of client expectations and rules of engagement Develop actionable project plans and vet through key team members Coordinate and collaborate with account leads in developing a plan for new or shifting tactics Review and provide input to project brief, budget, and schedule prior to kickoff Meeting Management Prepare for and lead all internal meetings Provide goals and objectives, pre-meeting Open all meetings with attendees/roles, goals/objectives of the meeting, and materials provided for the meeting Close all meetings with summary of discussion, decisions made, and immediate next steps Facilitate meetings to ensure meeting stays on track and on time Responsible for weekly status of the accounts they work on Workflow/Process Understand and advocate for the workflow process and each team member's role and responsibility within the workflow Review action orders (AOs) to ensure clear and executable direction is provided Lead the online routing of projects, while ensuring quality assurance at each step Maintain WF for all projects responsible for Communications Provide constant communication via teams, workfront, email, phont etc to meet client expectations and deliverables Client expectations and deliverables Resource allocation requirements Advocate for the team while monitoring delivery dates and budget burn Provide alternative solutions to ensure project stays on track Lead teams in clear, constructive, solutions oriented communications Growth/Advancement Opportunities Statement of work (SOW) review and input Research process and industry practices Identify and share best practices Qualifications: Minimum Required: Bachelor's Degree 2 years' direct work experience in a project management capacity, including all aspects of project planning through execution and delivery Other Required: Proficient in MS Office, including MS Project and/or an online project management workflow tool Experienced in digital, print and broadcast production May require travel domestically and/or internationally including overnight stays Preferred: Agency experience preferred. Pharmaceutical exposure desired Competencies: Proactive and effective communicator with multiple team members in varying departments Analytical in thinking (assumptions and risk evaluation) Flexible and agile Collaborative Thorough and efficient in time management Detail Oriented #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$60,000-$90,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
    $60k-90k yearly Auto-Apply 10d ago
  • Project Manager

    Healthsource of Ohio 3.7company rating

    Loveland, OH jobs

    The Project Manager is a hybrid remote position responsible for developing, managing, and leading large, complex strategic initiatives that support HealthSource of Ohio's mission of providing exceptional health care to everyone in the community. The Project Manager will have a deep understanding of project management, a strong understanding of process improvement methodologies, the ability to influence leaders on key decisions, and a willingness to be transparent about delivery challenges. The Project Manager will contribute to the development and design of project management capabilities, including the creation of processes and methods to effectively monitor and manage a portfolio of strategic initiatives. This role will provide guidance, facilitate communication, and work with senior leadership and management across the organization to plan, prioritize, and align strategic work. The Project Manager will support senior leaders and cross-functional teams in establishing processes for prioritizing, initiating, resourcing, and monitoring strategic initiatives. The Project Manager will help ensure project work aligns with organizational strategy and financial planning, maintaining strong alignment between initiatives, budgets, and strategic goals. In addition, the Project Manager will have a dedicated focus on supporting information technology components, ensuring all projects appropriately integrate IT functions and leadership. This includes confirming IT leadership is engaged at the appropriate stages and milestones throughout project planning and execution. Lead and manage complex, long-term strategic initiatives with enterprise-wide impact Partner with system, regional, and local leaders to prioritize, plan, resource, and monitor initiatives Develop and maintain project prioritization, governance, and milestone tracking processes Ensure alignment between strategic initiatives, organizational goals, and budgetary planning Collaborate closely with Finance, IT, Supply Chain, Facilities, and other stakeholders to strengthen project management capabilities Integrate IT leadership and functions into project planning and execution at appropriate milestones Escalate and resolve risks and issues impacting project delivery Support executive reporting, presentations, and strategic planning workshops Foster strong relationships, promote collaboration, and model adaptive, solution-oriented leadership Qualifications Bachelor's degree required; Master's degree (MBA, MHA, or MS) preferred Minimum of 2 years of successful project or program management experience across multiple functional areas PMP certification preferred Lean Six Sigma certification preferred **************************************************** HealthSource of Ohio is an Equal Opportunity/Affirmative Action Employer: Minority/Female/Disabled/Veteran Physical Activity 26-75% - Lift/Carry, Push/Pull (40 lbs.), Reach Overhead, Climb, Squat/Bend/Kneel, Sit, Stand, Walk/Move About
    $49k-76k yearly est. Auto-Apply 38d ago
  • Project Manager I (CRO or Life Sciences) - Remote

    MMS 4.7company rating

    Chicago, IL jobs

    MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions - rooted in strong science and decades of regulatory experience - that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit ******************* or follow MMS on LinkedIn. This position requires proven Project Management experience in support of Biometric deliverables (Data management, Biostatistics, Statistical Programming services). Job Responsibilities: Understands various cost models and develops budgets for moderate complexity projects. Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects. Controls project scope via defined PM methodology and processes for change management. Develops moderate complexity project timelines independently. Performs advanced functions in MSP. Understands task constraints and conveys critical path milestones to the functional lead. Develops/input into strategies to help achieve timeline expectations. Executes day-to-day activities during the course of a program/project including risk identification, issue escalation and resolution. Collaborates with functional line management to resolve any issues and trends. Drives customer satisfaction and works to strengthen client relationships. Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum). Manages minimum one key account. Participates in or leads bid defenses. Proficient in Word, Outlook, PowerPoint, Excel. Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met. Understands general requirements: ICH, 21CRF Part 11, and ISO 9001:2000. Requirements: Bachelor's Degree required, or relevant work experience. Minimum of 2 years' experience in project coordination or project management or similar field required. Expert knowledge of scientific principles and concepts. Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred. Good communication skills and willingness to work with others to clearly understand needs and solve problems. Excellent problem-solving skills. Good organizational and communication skills. Familiarity with current ISO 9001 and ISO 27001 standards preferred. Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Powered by JazzHR Vb1hE8LBAc
    $62k-93k yearly est. 17d ago
  • Project Manager I (CRO or Life Sciences) - Remote

    MMS 4.7company rating

    Zionsville, IN jobs

    MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions - rooted in strong science and decades of regulatory experience - that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit ******************* or follow MMS on LinkedIn. This position requires proven Project Management experience in support of Biometric deliverables (Data management, Biostatistics, Statistical Programming services). Job Responsibilities: Understands various cost models and develops budgets for moderate complexity projects. Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects. Controls project scope via defined PM methodology and processes for change management. Develops moderate complexity project timelines independently. Performs advanced functions in MSP. Understands task constraints and conveys critical path milestones to the functional lead. Develops/input into strategies to help achieve timeline expectations. Executes day-to-day activities during the course of a program/project including risk identification, issue escalation and resolution. Collaborates with functional line management to resolve any issues and trends. Drives customer satisfaction and works to strengthen client relationships. Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum). Manages minimum one key account. Participates in or leads bid defenses. Proficient in Word, Outlook, PowerPoint, Excel. Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met. Understands general requirements: ICH, 21CRF Part 11, and ISO 9001:2000. Requirements: Bachelor's Degree required, or relevant work experience. Minimum of 2 years' experience in project coordination or project management or similar field required. Expert knowledge of scientific principles and concepts. Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred. Good communication skills and willingness to work with others to clearly understand needs and solve problems. Excellent problem-solving skills. Good organizational and communication skills. Familiarity with current ISO 9001 and ISO 27001 standards preferred. Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Powered by JazzHR 3mKMoVPWsE
    $61k-92k yearly est. 17d ago
  • Project Manager I (CRO or Life Sciences) - Remote

    MMS 4.7company rating

    Aurora, CO jobs

    MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions - rooted in strong science and decades of regulatory experience - that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit ******************* or follow MMS on LinkedIn. This position requires proven Project Management experience in support of Biometric deliverables (Data management, Biostatistics, Statistical Programming services). Job Responsibilities: Understands various cost models and develops budgets for moderate complexity projects. Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects. Controls project scope via defined PM methodology and processes for change management. Develops moderate complexity project timelines independently. Performs advanced functions in MSP. Understands task constraints and conveys critical path milestones to the functional lead. Develops/input into strategies to help achieve timeline expectations. Executes day-to-day activities during the course of a program/project including risk identification, issue escalation and resolution. Collaborates with functional line management to resolve any issues and trends. Drives customer satisfaction and works to strengthen client relationships. Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum). Manages minimum one key account. Participates in or leads bid defenses. Proficient in Word, Outlook, PowerPoint, Excel. Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met. Understands general requirements: ICH, 21CRF Part 11, and ISO 9001:2000. Requirements: Bachelor's Degree required, or relevant work experience. Minimum of 2 years' experience in project coordination or project management or similar field required. Expert knowledge of scientific principles and concepts. Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred. Good communication skills and willingness to work with others to clearly understand needs and solve problems. Excellent problem-solving skills. Good organizational and communication skills. Familiarity with current ISO 9001 and ISO 27001 standards preferred. Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Powered by JazzHR Ojic18VjZX
    $60k-90k yearly est. 17d ago
  • Oncology Project Manager

    Medpace 4.5company rating

    Cincinnati, OH jobs

    Responsibilities * The primary role of the Project Manager is to provide tactical management, administration, and leadership to Medpace Core Laboratory's project teams in order to ensure that the project proceeds on time and within budget as it relates to central imaging, ECG, and/or remote biosensing technology data management; * Utilize study management tools to track: site start-up activities, site performance issues, submission of data, etc.; * Responsible for the delivery of Medpace Core Laboratory services to sponsors within expected timelines and budget; * Conducts ongoing study team meetings; * Performs scheduling of activities and deliverables in conjunction with client and internal customers; * Provides timely notification of all appropriate parties with deviations from timelines and/or deliverables; * Conducts regular communication with team members, formal and informal, regarding study status or any other changes; * Maintain ongoing Sponsor contact for project issues; serve as primary contact for Sponsor, internal project team and external imaging-related vendors. Qualifications * Advanced degree with a focus in oncology, cell biology, biomedical engineering, physics or related field with knowledge of imaging techniques, * Knowledge and experience with Imaging interpretation and acquisition required, * Prior experience in Imaging Core Lab is preferred, * Knowledge and understanding of basic oncology imaging response criteria, RECIST 1.1, Lugano, and RANO; and * Familiarity and basic understanding of CT, MRI, PET, and SPECT/CT. * Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $66k-97k yearly est. Auto-Apply 7d ago
  • Imaging Project Manager

    Medpace 4.5company rating

    Cincinnati, OH jobs

    Responsibilities * The primary role of the Project Manager is to provide tactical management, administration, and leadership to Medpace's Imaging group within our Core Laboratory in order to ensure that the project proceeds on time and within budget; * Utilize study management tools to track: site start-up activities, site performance issues, submission of data, etc.; * Responsible for the delivery of Medpace Imaging services to sponsors within expected timelines and budget; * Conducts ongoing study team meetings; * Performs scheduling of activities and deliverables in conjunction with client and internal customers; * Provides timely notification of all appropriate parties with deviations from timelines and/or deliverables; * Conducts regular communication with team members, formal and informal, regarding study status or any other changes; * Maintain ongoing Sponsor contact for project issues; serve as primary contact for Sponsor, internal project team and external imaging-related vendors. Qualifications * Bachelor's degree in life sciences and 3-5 years related pharmaceutical industry experience; Master's degree preferred * Knowledge and experience with Imaging interpretation and acquisition required; and * Prior experience in Core Lab preferred. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $66k-97k yearly est. Auto-Apply 23d ago
  • eClinical Project Manager

    Medpace 4.5company rating

    Cincinnati, OH jobs

    Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based eClinical Project Manager to join our Data Management team in our Cincinnati, OH office. This role will work with both local and international teams and will manage global studies. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities * Manage multiple projects from am eClinincal/eCOA perspective; * Develop and review study documentation related to eClinical/eCOA activities for clinical trials with sponsor companies and other departments; * Coordinate overall eClinical activities by serving as primary contact for the sponsor; * Monitor study timelines in relation to clinical trial needs; * Attend face to face sponsor meetings and Investigator Meetings Qualifications * Bachelor's degree and prior eClinical experience; including setting up and managing multiple eClinical/eCOA projects and acting as the main point of contact for the sponsor; * General knowledge of technology trends and system / application development; * Possess excellent organizational, prioritization, and time management skills; * A basic knowledge of medical terminology is needed, as well as knowledge of a scientific investigative methodologies and clinical research methodologies. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $66k-97k yearly est. Auto-Apply 16d ago
  • Neuroimaging Project Manager

    Medpace 4.5company rating

    Cincinnati, OH jobs

    Responsibilities * The primary role of the Project Manager is to provide tactical management, administration, and leadership to Medpace Core Laboratory's project teams in order to ensure that the project proceeds on time and within budget as it relates to central imaging, ECG, and/or remote biosensing technology data management; * Utilize study management tools to track: site start-up activities, site performance issues, submission of data, etc.; * Responsible for the delivery of Medpace Core Laboratory services to sponsors within expected timelines and budget; * Conducts ongoing study team meetings; * Performs scheduling of activities and deliverables in conjunction with client and internal customers; * Provides timely notification of all appropriate parties with deviations from timelines and/or deliverables; * Conducts regular communication with team members, formal and informal, regarding study status or any other changes; * Maintain ongoing Sponsor contact for project issues; serve as primary contact for Sponsor, internal project team and external imaging-related vendors. Qualifications * Phd in Neuroscience, biomedical engineering, physics or related field with knowledge * Knowledge and experience with Imaging interpretation and acquisition required; and * Prior experience in Imaging Core Lab preferred. * Knowledge and experience in advance neuroimaging methods for human brain mapping including: VBM, fMRI, DTI, MRS. * Knowledge of current image analysis software and methods for these imaging modalities is also essential. * Familiarity with other brain mapping modalities such as PET, SPECT/CT, considered a plus * Experience within clinical trials also a plus * Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $66k-97k yearly est. Auto-Apply 23d ago
  • Study Start-Up Project Manager (Cincinnati)

    Medpace 4.5company rating

    Cincinnati, OH jobs

    Do you enjoy working in a fast-paced environment where you are empowered to make strategic decisions and contribute to a growing and profitable company? Join us at Medpace! Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Global Study Start-Up Project Manager to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace. Incentives can include: Competitive bonus program, sign-on/relocation bonus, and equity awards. Location: Position is office based in Cincinnati, OH. Responsibilities * Efficiently manage successful execution of global start-up, maintenance, and close-out studies; * Effectively lead others in a matrix environment; * Perform quality checks on submission documents and site essential documents; * Prepare and approve informed consent forms; * Serve as a Sponsor point of contact for start-up and regulatory submissions items; * Review pertinent regulations to develop proactive solutions to start-up challenges; * Prepare new business proposals and present during bid defenses, general capabilities meetings, and audits; * Contribute to the growth and development of departmental staff, processes and systems. Qualifications * Bachelor's degree required, advanced degree in Life Sciences preferred * Experience with Cardiovascular and Metabolic indications in an academic and/or clinical trial setting is desired, such as, but not limited to, NASH, diabetes, medical devices and coronary artery diseases. * 5+ years of experience in clinical research, preferably in a Senior/Lead role at a CRO in Study Start-Up * Project management experience and demonstrated role in developing others * Strong oral and written communication skills required Travel: Minimal Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $66k-97k yearly est. Auto-Apply 17d ago
  • Project Manager

    Hikma Pharmaceuticals 4.9company rating

    Bedford, OH jobs

    Job Title: Project Manager Job Type: Full-time (onsite) About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Project Manager. In this role, you will be responsible for coordinating and ensuring completion of manufacturing projects by a set deadline to uphold business initiatives. This position will be responsible for the oversight of all aspects of projects, setting deadlines, assigning responsibilities, and monitoring and summarizing progress of projects. Key Responsibilities: * Coordinate internal resources and cross-functional groups for flawless execution of multiple projects * Ensure that all projects are delivered on-time, within scope and within budget * Report and escalate to management as needed * Meet with site leadership to clarify specific requirements of each project and to keep project aligned with their goals * Manage the relationship with site leadership and relevant stakeholders * Facilitate resource availability and allocation * Create long- and short-term plans, including setting targets for milestones and adhering to deadlines * Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques * Perform risk management to minimize potential risks * Make effective decisions when presented with multiple options for how to progress with the project * Delegate project tasks based on team members' individual strengths, skill sets, and experience levels * Performing quality control on the project throughout development to maintain the standards expected * Assist in the definition of project scope and objectives, involving all relevant internal stakeholders and ensuring technical feasibility * Develop comprehensive project plans to be shared with team members as well as other staff members * Develop a detailed project plan to monitor and track progress * Measure performance using appropriate project management tools and techniques * Create and maintain comprehensive project documentation * Track project performance, specifically to analyze the successful completion of short and long-term goals * Develop spreadsheets, diagrams and process maps to document needs * Use and continually develop leadership skills * Attend conferences and training as required to maintain proficiency * Perform other related duties as assigned * Site Engineering - Collaboration to define scope of projects, equipment/process design, schedule generations/execution, regular check-ins on project status * Technical Services - Collaboration to define validation needs/timing, regular check-ins on project status * Manufacturing - Collaboration to determine production needs, coordination of labor and resources, communication of project schedules and status updates * QA/QC & EHS - Documentation approvals, collaboration on compliance issues, communication of project schedules and status updates * Vendor/Contractors as required for project related follow-up and communication Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * B.S. degree in engineering or science is required. * 2-4 years of experience in pharmaceutical manufacturing, and 2-4 years of experience in project management * Knowledge of cGMPs, FDA guidelines, and pharmaceutical industry practices * Demonstrated knowledge of pharmaceutical facilities and production equipment * Proven working experience in project management and capable of managing multiple projects at once * Excellent client-facing and internal communication skills * Excellent written and verbal communication skills * Solid organizational skills including attention to detail and multitasking skills * Strong working knowledge of Microsoft Office * Experience with project management software tools Compensation: Base Salary: $62,700 to $130,300 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Bedford, OH, US, 44146 Nearest Major Market: Cleveland
    $62.7k-130.3k yearly Auto-Apply 7d ago

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