Program Manager jobs at Charles River Labs

Clinical Project Manager - Rare Disease San Diego, CA - On- Site $115,000 - $140,000 A clinical-stage biotech company in San Diego is seeking a Clinical Development Operations Lead to manage global clinical trials and support regulatory strategy across a diverse pipeline. This role is ideal for someone with a strong foundation in clinical research, regulatory coordination, and cross-functional leadership. Key Responsibilities Clinical Trial Oversight: Lead the planning, execution, and closeout of global clinical studies, ensuring alignment with development and regulatory goals. Protocol & Site Management: Contribute to protocol design, site selection, and ongoing site relationships. Regulatory Support: Assist in the preparation of regulatory documents (e.g., INDs, briefing books, investigator brochures) and support health authority interactions. Cross-Functional Collaboration: Partner with internal teams across clinical operations, data management, medical affairs, and external vendors. Scientific Contribution: Review clinical data, support interpretation of results, and contribute to publications and presentations. Process Optimization: Participate in internal process improvement initiatives and mentor junior team members. Budget & Vendor Management: Develop and manage clinical trial budgets and oversee CROs and other external partners. Qualifications Advanced degree in life sciences (PharmD, PhD or MS required). 5-7 years of clinical experience in biotech or pharmaceutical settings. Proven track record in IND submissions and regulatory interactions. Experience in rare diseases, metabolic, CNS, or liver/kidney indications preferred. Familiarity with RNA-based platforms (si RNA, ASO) is a plus. Strong project management, communication, and leadership skills. Ability to work across time zones and manage international teams This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.

Job Title: Project Manager - Life Sciences Employment Type: Full-Time About the Role: We are seeking an experienced Project Manager to lead and deliver complex projects within the life sciences sector. This role requires strong technical expertise and hands-on experience with DeltaV and OSIsoft PI systems, ensuring successful implementation and integration across manufacturing and automation environments. Key Responsibilities Manage end-to-end project lifecycle for automation and process control initiatives in life sciences. Coordinate cross-functional teams including engineering, validation, and operations. Develop and maintain project plans, timelines, budgets, and resource allocation. Ensure compliance with regulatory standards (GMP, FDA, etc.). Oversee implementation and optimization of DeltaV distributed control systems. Manage data integration and analytics using OSIsoft PI for process monitoring and reporting. Identify risks, develop mitigation strategies, and ensure timely project delivery. Communicate project status and updates to stakeholders and leadership. Required Qualifications Bachelor's degree in Engineering, Life Sciences, or related field. 5+ years of project management experience in life sciences or pharmaceutical manufacturing. Proven experience with DeltaV automation systems and OSIsoft PI data historian. Strong understanding of process control, automation, and data analytics. Excellent leadership, communication, and stakeholder management skills. Familiarity with GMP and regulatory compliance requirements. Preferred Qualifications PMP or equivalent project management certification. Experience with large-scale automation projects in biotech or pharmaceutical environments. Knowledge of validation processes and documentation standards. Why Join Us? Work on cutting-edge projects in a world-class life sciences hub. Collaborative team environment with opportunities for growth. Competitive compensation and benefits package.

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. Join Our Medical Communications Team at Parexel as a Senior Program Specialist Are you a seasoned project manager or account manager with experience in medical communications-particularly in publications? We're seeking a Senior Program Specialist to lead the execution of complex, multidisciplinary publication programs while driving excellence across cross-functional teams. This is a full-time, remote position that may require occasional travel. This is a full time remote position. Candidates need to work out of Canada or the continental United States. What You'll Do As a Senior Program Specialist, functioning as a program/project manager you will: Lead and facilitate program/project kick-off meetings, establishing clear roles, responsibilities, and expectations across internal teams and external stakeholders. Develop and manage comprehensive project plans, delivery schedules, and tracking systems to ensure timely, high-quality execution. Maintain proactive communication with clients, faculty, and internal teams, serving as the key point of contact for project status updates and issue resolution. Monitor budgets, timelines, and deliverables, identifying risks and resolving issues promptly to keep projects on track and within scope. Collaborate cross-functionally to define project scope, staffing requirements, and implementation strategies, raising concerns and adjusting plans as needed. Support proposal development and budgeting processes, contributing to program specifications, cost assessments, and implementation planning. Champion best practices in communication, process efficiency, and team collaboration, continuously identifying opportunities for improvement and innovation. Ensure alignment with strategic goals and product messaging, working closely with Account Managers/Directors and functional teams to deliver impactful solutions. What You Bring Must have 5+ years experience in medical communications project management, (Publications). Proven ability to lead teams and deliver projects on time and within budget. Strong organizational, negotiation, and interpersonal communication skills. Advanced proficiency in Microsoft Word, PowerPoint, Excel, Outlook, and database tools. iEnvision experience is required. Familiarity with publication guidelines (e.g. ICMJE). Bachelor's degree required; Master's preferred in Business or Life Sciences. Why You'll Love Working Here Be part of a collaborative and innovative team. Work on impactful healthcare and scientific programs. Enjoy a flexible work environment with growth opportunities. Ready to make a difference? Apply today and bring your expertise to a team that values excellence, innovation, and collaboration. 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.

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. Join Our Medical Communications Team at Parexel as a Senior Program Specialist Are you a seasoned project manager or account manager with experience in medical communications-particularly in publications? We're seeking a Senior Program Specialist to lead the execution of complex, multidisciplinary publication programs while driving excellence across cross-functional teams. This is a full-time, remote position that may require occasional travel. This is a full time remote position. Candidates need to work out of Canada or the continental United States. What You'll Do As a Senior Program Specialist, functioning as a program/project manager you will: Lead and facilitate program/project kick-off meetings, establishing clear roles, responsibilities, and expectations across internal teams and external stakeholders. Develop and manage comprehensive project plans, delivery schedules, and tracking systems to ensure timely, high-quality execution. Maintain proactive communication with clients, faculty, and internal teams, serving as the key point of contact for project status updates and issue resolution. Monitor budgets, timelines, and deliverables, identifying risks and resolving issues promptly to keep projects on track and within scope. Collaborate cross-functionally to define project scope, staffing requirements, and implementation strategies, raising concerns and adjusting plans as needed. Support proposal development and budgeting processes, contributing to program specifications, cost assessments, and implementation planning. Champion best practices in communication, process efficiency, and team collaboration, continuously identifying opportunities for improvement and innovation. Ensure alignment with strategic goals and product messaging, working closely with Account Managers/Directors and functional teams to deliver impactful solutions. What You Bring Must have 5+ years experience in medical communications project management, (Publications). Proven ability to lead teams and deliver projects on time and within budget. Strong organizational, negotiation, and interpersonal communication skills. Advanced proficiency in Microsoft Word, PowerPoint, Excel, Outlook, and database tools. iEnvision experience is required. Familiarity with publication guidelines (e.g. ICMJE). Bachelor's degree required; Master's preferred in Business or Life Sciences. Why You'll Love Working Here Be part of a collaborative and innovative team. Work on impactful healthcare and scientific programs. Enjoy a flexible work environment with growth opportunities. Ready to make a difference? Apply today and bring your expertise to a team that values excellence, innovation, and collaboration. 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.

ApotheCom is an exciting leader in the field of medical communications. Drawn together from several backgrounds including the pharmaceutical industry, research, marketing, medical and regulatory writing, sales, publishing, digital media and design, we have the experience and all-round ability to conceive and deliver the best quality medical communications programs. About the Role At ApotheCom, we believe science has the power to change lives-and we help our clients share that science with the world. As a Program Manager on our publications team, you'll be the operational backbone of client projects, ensuring that every element-timelines, budgets, deliverables, and communications-runs smoothly. You'll collaborate across internal teams and with clients, medical experts, and vendors to deliver high-quality publications and scientific content that make an impact. This is a great opportunity for someone who thrives on organization, loves working in a fast-paced environment, and wants to contribute to meaningful work that advances healthcare. What You'll Do Own project operations: Manage day-to-day tasks across multiple publication programs, keeping timelines, budgets, and deliverables on track. Be the communication hub: Coordinate with internal scientific, creative, and digital teams to align on priorities and progress. Keep clients informed: Develop and distribute project status reports and updates to ensure full visibility. Drive efficiency: Route materials for review, consolidate feedback, and ensure all deadlines are met. Support growth: Help prepare proposals and pricing estimates for new projects and initiatives. Manage budgets: Build, track, and reconcile budgets-reporting progress and resolving issues as they arise. Lead meetings: Schedule and facilitate kick-offs, team check-ins, and client discussions. Ensure accuracy: Draft and proof client correspondence, project summaries, and meeting materials. What You Bring Bachelor's degree required (Life Sciences or related field preferred). 2-4 years of experience in medical communications, ideally with exposure to publications or program management. Strong communication skills-written, verbal, and interpersonal. Comfort managing multiple projects and priorities in a fast-moving environment. Strong financial and organizational acumen; skilled with Excel and project tracking tools. A proactive, team-focused attitude and a keen eye for detail. Passion for science and enthusiasm for bringing new treatments and innovations to patients. Benefits: Health coverage Retirement plan PTO ApotheCom can offer an attractive rewards package, excellent development opportunities, a supportive and friendly environment and the opportunity to achieve your potential. Our Pledge At ApotheCom, we value inclusivity, recognize the power of diversity and inspire the next generation of change-makers. We are an equal opportunities employer. We believe in creating a work environment that values diversity, equity and inclusion. We aim to recruit from a diverse slate of candidates and foster an environment that provides the right conditions for long-term success. We welcome all applications regardless of race, color, religion or belief, gender, gender identity, age, national origin, marital status, military veteran status, genetic information, sexual orientation and physical or mental disability. ApotheCom is part of Inizio Medical. Inizio is a strategic partner for health and life sciences with a full suite of medical, marketing, advisory and engagement services. The base salary range represents the low and high end of the salary range for this position. This range may differ based on your experience and skill set, geographic location, and cost of living considerations. We consider compensation more than just a base salary - that's why we also offer an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work.Compensation$60,000-$78,000 USD Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.

Job Description Scientific Program Manager & Biologics SME (Subject Matter Expert) Fulltime Exton, PA Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary The Scientific Program Manager & Biologics SME will serve as the primary scientific liaison for large molecule bioanalytical programs, including PK, immunogenicity (ADA), cell-based and non-cell-based neutralizing antibody (NAb) assays, and other complex ligand-binding and cell-based assay platforms. This role combines scientific expertise and client-facing communication to drive successful execution of GLP, non-GLP, and clinical support studies within the Biologics Service group. The position works closely with laboratory operations, quality assurance, program management, and business development teams to ensure technical excellence, regulatory compliance, and efficient delivery of high-quality data to sponsors. Key Responsibilities: Scientific Liaison & SME Support: Present and introduce Biologics services to clients, including LBA-based assays for PK, ADA, NAb, and cell-based functional assays. Provide scientific consultation during pre-clinical and clinical program design, including assay selection, format, feasibility, and method development strategy. Serve as subject matter expert on large molecule assay performance, MRD, analytical range, cut-point strategy, validation parameters, and sample analysis workflow. Program Management & Client Engagement: Act as scientific point-of-contact for assigned programs; attend kickoff, alignment, troubleshooting, and result review meetings. Coordinate with Program Management to ensure timelines, deliverables, and sponsor expectations are clearly communicated and met. Prepare or review scientific sections of proposals, protocols, validation plans, and study reports. Collaborate with lab supervisors and technical teams to troubleshoot assay challenges and implement scientific improvements. Regulatory & Quality Compliance: Familiar with appropriate regulatory frameworks, including FDA 21 CFR Part 58 (GLP) Non-GLP discovery and early development programs. Clinical sample testing requirements (GCP interface). Partner with QA and Compliance on audits, data integrity requirements, documentation accuracy, and deviation investigations. Qualifications: Required Master's degree or higher in Biology, Biochemistry, Pharmaceutical Sciences, Immunology, or related field (PhD preferred but not required). 5+ years of hands-on experience developing, validating, and troubleshooting large molecule assays, including PK (ligand-binding assays), ADA (screening, confirmatory, titration). Cell-based NAb assays. Other functional / MOA-based cell assays. Demonstrated knowledge of GLP regulations (21 CFR Part 58) and experience supporting non-GLP and clinical programs. Strong ability to interpret complex scientific data and communicate clearly with internal teams and external sponsors. Experience working in a CRO or regulated bioanalytical environment strongly preferred. Preferred Experience in a leadership or supervisory role. Familiarity with BioA reporting structures, immunogenicity risk assessments, and cut-point strategies. Experience interacting with regulatory agencies or contributing to submissions. Competencies Strong scientific communication and presentation skills. Ability to lead projects cross-functionally and coordinate with operations, PM, BD, and QA. Strategic problem-solving mindset with attention to detail. Client-focused, collaborative, and able to operate in a fast-paced CRO environment. Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Scientific Program Manager & Biologics SME (Subject Matter Expert) Fulltime Exton, PA Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary The Scientific Program Manager & Biologics SME will serve as the primary scientific liaison for large molecule bioanalytical programs, including PK, immunogenicity (ADA), cell-based and non-cell-based neutralizing antibody (NAb) assays, and other complex ligand-binding and cell-based assay platforms. This role combines scientific expertise and client-facing communication to drive successful execution of GLP, non-GLP, and clinical support studies within the Biologics Service group. The position works closely with laboratory operations, quality assurance, program management, and business development teams to ensure technical excellence, regulatory compliance, and efficient delivery of high-quality data to sponsors. Key Responsibilities: Scientific Liaison & SME Support: Present and introduce Biologics services to clients, including LBA-based assays for PK, ADA, NAb, and cell-based functional assays. Provide scientific consultation during pre-clinical and clinical program design, including assay selection, format, feasibility, and method development strategy. Serve as subject matter expert on large molecule assay performance, MRD, analytical range, cut-point strategy, validation parameters, and sample analysis workflow. Program Management & Client Engagement: Act as scientific point-of-contact for assigned programs; attend kickoff, alignment, troubleshooting, and result review meetings. Coordinate with Program Management to ensure timelines, deliverables, and sponsor expectations are clearly communicated and met. Prepare or review scientific sections of proposals, protocols, validation plans, and study reports. Collaborate with lab supervisors and technical teams to troubleshoot assay challenges and implement scientific improvements. Regulatory & Quality Compliance: Familiar with appropriate regulatory frameworks, including FDA 21 CFR Part 58 (GLP) Non-GLP discovery and early development programs. Clinical sample testing requirements (GCP interface). Partner with QA and Compliance on audits, data integrity requirements, documentation accuracy, and deviation investigations. Qualifications: Master's degree or higher in Biology, Biochemistry, Pharmaceutical Sciences, Immunology, or related field (PhD preferred but not required). 5+ years of hands-on experience developing, validating, and troubleshooting large molecule assays, including PK (ligand-binding assays), ADA (screening, confirmatory, titration). Cell-based NAb assays. Other functional / MOA-based cell assays. Demonstrated knowledge of GLP regulations (21 CFR Part 58) and experience supporting non-GLP and clinical programs. Strong ability to interpret complex scientific data and communicate clearly with internal teams and external sponsors. Experience working in a CRO or regulated bioanalytical environment strongly preferred. Preferred Experience in a leadership or supervisory role. Familiarity with BioA reporting structures, immunogenicity risk assessments, and cut-point strategies. Experience interacting with regulatory agencies or contributing to submissions. Competencies Strong scientific communication and presentation skills. Ability to lead projects cross-functionally and coordinate with operations, PM, BD, and QA. Strategic problem-solving mindset with attention to detail. Client-focused, collaborative, and able to operate in a fast-paced CRO environment. Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Scientific Program Manager & Biologics SME (Subject Matter Expert) Fulltime Exton, PA Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary The Scientific Program Manager & Biologics SME will serve as the primary scientific liaison for large molecule bioanalytical programs, including PK, immunogenicity (ADA), cell-based and non-cell-based neutralizing antibody (NAb) assays, and other complex ligand-binding and cell-based assay platforms. This role combines scientific expertise and client-facing communication to drive successful execution of GLP, non-GLP, and clinical support studies within the Biologics Service group. The position works closely with laboratory operations, quality assurance, program management, and business development teams to ensure technical excellence, regulatory compliance, and efficient delivery of high-quality data to sponsors. Key Responsibilities: Scientific Liaison & SME Support: * Present and introduce Biologics services to clients, including LBA-based assays for PK, ADA, NAb, and cell-based functional assays. * Provide scientific consultation during pre-clinical and clinical program design, including assay selection, format, feasibility, and method development strategy. * Serve as subject matter expert on large molecule assay performance, MRD, analytical range, cut-point strategy, validation parameters, and sample analysis workflow. Program Management & Client Engagement: * Act as scientific point-of-contact for assigned programs; attend kickoff, alignment, troubleshooting, and result review meetings. * Coordinate with Program Management to ensure timelines, deliverables, and sponsor expectations are clearly communicated and met. * Prepare or review scientific sections of proposals, protocols, validation plans, and study reports. * Collaborate with lab supervisors and technical teams to troubleshoot assay challenges and implement scientific improvements. Regulatory & Quality Compliance: * Familiar with appropriate regulatory frameworks, including FDA 21 CFR Part 58 (GLP) * Non-GLP discovery and early development programs. * Clinical sample testing requirements (GCP interface). * Partner with QA and Compliance on audits, data integrity requirements, documentation accuracy, and deviation investigations. Qualifications: Required * Master's degree or higher in Biology, Biochemistry, Pharmaceutical Sciences, Immunology, or related field (PhD preferred but not required). * 5+ years of hands-on experience developing, validating, and troubleshooting large molecule assays, including PK (ligand-binding assays), ADA (screening, confirmatory, titration). Cell-based NAb assays. * Other functional / MOA-based cell assays. * Demonstrated knowledge of GLP regulations (21 CFR Part 58) and experience supporting non-GLP and clinical programs. * Strong ability to interpret complex scientific data and communicate clearly with internal teams and external sponsors. * Experience working in a CRO or regulated bioanalytical environment strongly preferred. Preferred * Experience in a leadership or supervisory role. * Familiarity with BioA reporting structures, immunogenicity risk assessments, and cut-point strategies. * Experience interacting with regulatory agencies or contributing to submissions. Competencies * Strong scientific communication and presentation skills. * Ability to lead projects cross-functionally and coordinate with operations, PM, BD, and QA. * Strategic problem-solving mindset with attention to detail. * Client-focused, collaborative, and able to operate in a fast-paced CRO environment. Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Scientific Program Manager & Biologics SME (Subject Matter Expert)

C Corium Innovations is seeking a Program Manager to manage program deliverables, timelines and budgets for internal and external development, commercial, and continuous improvement programs and projects in the pharmaceutical industry. This is a unique opportunity to take on a key role with a broad range of responsibilities. Your most Innovative career move is here! At Corium Innovations, we've led the way in innovating drug delivery technologies for millions of patients whose GI systems just can't tolerate pills, who can't remember to take their meds as directed, or who have needle-phobia. This is only the beginning! There's so much more to deliver, and we need YOU to do it! Our Purpose is to create, develop and manufacture innovative healthcare products for partners that deliver superior value to patients. Our Goal is to be the best-in-class specialty CDMO through the use of innovative technologies and superior execution. Our Company Values are core to our positive and people-centric culture which inspires all of us to come to work every day on behalf of our people, our partners, our customers, and our patients. Through our four core values, we put people first and create opportunities to make each day better than the last. Celebrate Individuals: We're looking for talent who will celebrate the uniqueness of each of our team members by encouraging everyone to bring their authentic self to work. Successful Together: We believe we're better together, so we prioritize teamwork as we work to achieve our shared vision knowing each one of us has an important role to play. Embrace Innovation: We embrace new challenges and opportunities while encouraging creative thinking and innovative solutions to best meet the needs of our people and our partners. Pride in Ownership: We take pride in owning our progress and successes, feeling empowered to pursue our growth to reach our full potential. And we hope you will too! Responsibilities: • Develops, maintains and owns Corium Innovations project management system and procedures, including the Microsoft Dynamics D365 project module and the Product Development Process while also managing programs to meet PDP requirements which ensures compliance to combination product regulations for development and commercial programs. • Participates as a core member of the Corium Innovations Operations Leadership Team, which is responsible for oversight of all Corium Innovations site operations. • Develops project scope, budgets and timelines with the input, support and alignment of cross-functional team members and leadership. Tracks, identifies, and resolves scope changes as well as communicates these changes to internal and external partners and ensures appropriate leadership approvals. Also manages CRO's and Clinical Trial Reports Database. • Partners directly with COO, CBO and CTO in reacting to new RFPs and subsequently developing new business proposals, while also managing site visits and due diligence for new potential customers. • Coordinates internal and external project meetings, including agendas and minutes including action items and follow up as necessary. • Provides project updates to internal management and partners. • Participates in the strategic planning for long range projects, including business impact. • Reviews project hours and out-of-pocket expenses monthly to ensure accurate time reporting and budget adherence. Works with management to address labor/expense overage. • Forecasts labor hours, using analytical tools, to understand potential labor overages. • Partners with the Finance Department with development and implementation of tools for project budgeting; leads month-end billing and authorization of invoices as they pertain to project deliverables and milestones. • Mentors, guides and provides oversight to less senior project/program managers as necessary. • Responsible for long range financial planning for multiple projects or programs, including prediction of cash flow on a fiscal year (or longer) basis. • Partners with COO in ownership of the project management department budget. • Supports the cross-functional project teams in the structured and timely submission of regulatory applications and supplements. • Supports partner, ISO, or regulatory audits / inspections to ensure team inspection readiness. • Coordinates the scheduling, agenda, and minutes for Quarterly Business Reviews (QBRs)with partners as appropriate. Participates in QBR meetings, including providing executive level updates and presenting information to gain agreement on changes in scope, status, or direction of a project. • Responsible for managing multiple projects or programs while objectively assessing progress, likelihood of success and alignment with corporate objectives. In doing so, makes recommendations for progression or remediation of programs and projects. Qualifications: • Bachelor of Science Degree; MS/MBA preferred. • PMP or other project management certification preferred; pharma preferred • 10+ years related experience, including at least 3 years managing pharmaceutical programs. • Microsoft Word, Excel, Powerpoint, Outlook and Project. • Strong operational knowledge of the product development life cycle with regards to new and generic drugs. • Must be able to interact with individuals at all levels of the organization as well as external strategic partners and regulatory authorities. • Must be able to maintain strict confidentiality regarding internal and external information. • Must be detail-oriented and able to provide self-direction. • Must be able to provide coaching and constructive criticism to project management • Strategic analytical thinker with strong business acumen. • Proven ability to make sound decisions about allocation of resources and managing priorities. • Demonstrated team leadership capabilities with a proven track record of meeting objectives. • Ability to plan over a 12-to-24-month time span. • Excellent interpersonal and communication skills. • Strong team player. Benefits: Highly competitive benefits program including medical, dental, vision, flexible spending accounts, life insurance, disability insurance, and employee assistance program. 401(k) retirement savings account with a company match and immediate vesting. 12 paid holidays. Competitive paid vacation plan plus ~1 additional week of paid time off for our annual holiday shutdown.

Summary of Job Description: The Program Manager provides overall management and supervision of the agency's housing program; including supervision of staff, oversight of rental assistance and housing counseling services, support in the development and monitoring of budgets, developing, and implementing policies and procedures, and participating in obtaining ongoing funding/grants to support Housing Services. This position is responsible for data collection and reporting, maintaining adequate monitoring and reporting systems to ensure adequacy, quality, and program services timeliness. Participating in continuous quality improvement and quality management activities; and participating in various community collaborations and administrative responsibility for housing counseling services. The Program Manager is directly responsible to the Director of Housing and Emergency Services. Summary of Requirements: bachelor's degree in human services field such as public administration, social work, psychology, sociology, or related field. Two to five years of professional experience is required in the housing field, such as housing counseling, affordable housing (Public/Section 8/Tax Credit, Etcetera.), real estate, property management, lending, or related experience. Experience in the management of federal and state grants is a plus. Nonprofit sector experience preferred. Possess a demonstrated successful track record of mid-management level agency oversight. A strong background in program management, personnel management, and community engagement is required. Working knowledge of the community action agency network is a plus but not required. Other experience requirements include grants management and oversight of major programs; budget, planning, effective working relationships at the federal, state, regional, and local governmental levels; excellent written, verbal, and technology-driven communication and presentation skills; public speaking; and effective team-based leadership. Strong ability to work independently and as a team player exercising mature judgment; Highly motivated self-starter with a capacity to complete multiple tasks in a timely manner; Must have excellent problem-solving skills and ability to develop innovative solutions; Must demonstrate the ability to communicate with a variety of professionals including bankers, realtors, and landlords; Must maintain and execute confidential information; Ability to translate technical information; and sensitive to the needs within the community and individuals. Skills and intermediate proficiency using and navigating the agency's client management system CAP60 and Microsoft 365 - Word, Excel, Outlook, Publisher, TEAMS (virtual platform), and other software applications to retrieve data, create spreadsheets and generate reports. Communication Skills: Communicates effectively and professionally, using tact, discretion, and diplomacy in both written and verbal formats with coworkers, supervisors, customers, and vendors. Demonstrate team-building skills to establish and maintain good working relationships with colleagues and staff. Demonstrates the ability to analyze problems/issues, gather data and information, evaluate, and recommend alternative solutions, or effect solutions with a tolerance for ambiguity and change, when necessary. Responsibilities and Duties: According to HUD regulations and the National Industry standards for homeownership counseling, manage the agency's housing counseling program. Include identifying and securing funds for program operations, ensuring that housing education and counseling are conducted, maintaining effective communications with funding sources, participating in internal and external monitoring reviews, and preparing monthly programmatic reports required by agency and funding sources. Assist with grants management and budgeting. - Research grant opportunities - Prepare grant narratives. - Prepare budget drafts. - Participate in strategic planning and program evaluations. - Monitor progress. Other duties as assigned. Licenses or Certificates: Certified by HUD as a Housing Counselor required. Certifications in Post Purchase Homeownership Education, Pre-Purchase Homeownership Education, Foreclosure Intervention/Default Counseling, and Financial Capability within one year of employment. Possess a valid Maryland Driver's License. Special Requirements: State and Federal Bureau of Investigation Criminal Background Check, National Sex Offender Public Registry Check, Current Certified Driving Record, Physical, Tuberculin PPD Tine Test at the time of employment, and annually, or by physician requirement, thereafter, and Pre-Employment, Random, Post-Accident Drug, and Alcohol testing. Must be available to meet with customers on evenings or Saturdays as needed. Physical Demands: Work requires limited physical effort. An Equal Opportunity/Affirmative Action Employer

We are seeking an entry-level, analytically-oriented Associate Project Manager to join our team! Our ideal candidate is someone who thrives in a fast-paced and dynamic environment, and takes initiative to seek out information, knowledge, and development, proactively. He or she is a resourceful problem solver who is savvy with technology and finds effective and efficient solutions to complex client problems. The Associate Project Manager is a true self-starter who deals well with uncertainty and ambiguity. Lastly, he or she is a proven team player who puts the success of the team first. Responsibilities include (but are not limited to): * Work as part of a cross-functional project team responsible for the delivery of Interactive Response Technology (IRT) for randomization and drug supply management in clinical trials * Support the Services Delivery project team in: * Liaising with the client to discuss requirements, handle issues, provide status updates, and answer questions * Designing the IRT solution to meet the study requirements based on the clinical protocol, Suvoda proposal and discussions with the client * Accurately and completely documenting all requirements and participating in internal and external specification review meetings * Assisting with client review meetings of IRT specifications and supporting documents, making any required updates * Managing project schedules and scope, tracking all internal and client tasks required to meet project milestones * Managing the cross-functional project team's schedule and task assignments * Assisting with creating the UAT plan, developing test scripts, coordinating data setup, and providing client support for client UAT * Providing protocol-specific support to the client and support team after go-live * Ensure client satisfaction throughout the project build and maintenance phase, working with Suvoda management, the Suvoda product team, and business development as needed * Provide system training to end-users using in-person meetings, web meetings, and user manuals * Provide telephone and email support to system users globally * Travel to client sites to attend meetings and conduct user training sessions * Perform other related duties as required Requirements: * Bachelor's degree (in life sciences or computer science preferred) * Interpersonal and communication skills * Time management and organizational skills * Analytical thinking ability * Creative problem-solving ability * Attention to detail Special Note: Applicants must be currently authorized to work in the United States on a full-time basis. #LI-AC1 We are aware that an individual(s) are fraudulently representing themselves as Suvoda recruiters and/or hiring managers. Suvoda will never request personal information such as your bank account number, credit card number, drivers license or social security number - or request payment from you - during the job application or interview process. Any emails from the Suvoda recruiting team will come from ************* email address. You can learn more about these types of fraud by referring to this FTC consumer alert. As set forth in Suvoda's Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you are based in California, we encourage you to read this important information for California residents linked here.

Job Description Associate Project Manager- Bioanalytical & Biologics Services Reports to: Group Leader, BioA Project Management Full-time Frontage Laboratories: Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Bioanalytical & Biologics Services: At Frontage, we believe that we deliver high quality services through our focus on technical excellence, which enables us to understand and solve complex drug development challenges. Our deep scientific expertise in method development, transfer and validation allows us to provide clients with complex solutions for challenging studies including oncology clinical trials, rare disease assay development and specialty assays Position Summary: -Manage and monitor project progress and timelines to ensure successful completion from start up to end of study. -Participate and communicate effectively in project meetings with clients on a regular basis as well as with cross-functional teams to ensure projects are met with quality and within the applicable scope and budget. -Collaborate with the financial sector throughout various stages of projects (monthly invoices, revenue recognition, and budget final reconciliation). -Support Management and BD team for new business opportunities. -Onsite is required as needed. Position Responsibilities: -Minimizes risks on projects by working closely with the lab operations and lab support teams, PIs, and sponsors to ensure project progress is met for each milestone in accordance with project scope per requested timelines by the sponsor. -Creates, updates and tracks projects in project management tool (QuickBase) daily and generating project trackers and reports as requested. -Leads/participate in project meetings with sponsors on a regular basis or on as needed basis and prepare meeting minutes to ensure alignment of deliverables. -Serves as a liaison between internal departments (scientific staff, QC/TW, QA, SM, etc.) to ensure project timelines are met with quality. -Proactively communicate with clients on project timelines, issues, and updates via phone, e-mails, or TC as necessary. -Requests and reviews invoices per milestone on a rolling basis that are tracked in QuickBase and respond to client's questions related to invoices or finance aspects or assists finance team on those issues as needed (i.e. revenue recognition per month and final budget reconciliation. -Facilitate internal and external communication and activities on data transfer specification (DTS) development and complete data transfers to data management vendors/sponsors. -Participate in onsite client visits and assist internally in preparation as necessary. Position Requirements: Bachelor's degree or higher in biological sciences, chemistry, or related discipline. In-depth knowledge of bioanalytical and/or biologics assays. Minimum 1-2 years of project management experience in GLP, Pharmaceutical or CRO environment. Excellent communication and strong client relationship management skills. Proficient with Excel, Word, PowerPoint and other computer skills. Good Time Management/ Organizational skills adopting a committed approach to providing a high level of customer service when managing multiple tasks. Demonstrated professionalism including excellent work ethic, positive attitude and experience communicating with external clients. Salary and Benefits: Frontage Laboratories offer a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Associate Project Manager- Bioanalytical & Biologics Services Reports to: Group Leader, BioA Project Management Full-time Frontage Laboratories: Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Bioanalytical & Biologics Services: At Frontage, we believe that we deliver high quality services through our focus on technical excellence, which enables us to understand and solve complex drug development challenges. Our deep scientific expertise in method development, transfer and validation allows us to provide clients with complex solutions for challenging studies including oncology clinical trials, rare disease assay development and specialty assays Position Summary: * Manage and monitor project progress and timelines to ensure successful completion from start up to end of study. * Participate and communicate effectively in project meetings with clients on a regular basis as well as with cross-functional teams to ensure projects are met with quality and within the applicable scope and budget. * Collaborate with the financial sector throughout various stages of projects (monthly invoices, revenue recognition, and budget final reconciliation). * Support Management and BD team for new business opportunities. * Onsite is required as needed. Position Responsibilities: * Minimizes risks on projects by working closely with the lab operations and lab support teams, PIs, and sponsors to ensure project progress is met for each milestone in accordance with project scope per requested timelines by the sponsor. * Creates, updates and tracks projects in project management tool (QuickBase) daily and generating project trackers and reports as requested. * Leads/participate in project meetings with sponsors on a regular basis or on as needed basis and prepare meeting minutes to ensure alignment of deliverables. * Serves as a liaison between internal departments (scientific staff, QC/TW, QA, SM, etc.) to ensure project timelines are met with quality. * Proactively communicate with clients on project timelines, issues, and updates via phone, e-mails, or TC as necessary. * Requests and reviews invoices per milestone on a rolling basis that are tracked in QuickBase and respond to client's questions related to invoices or finance aspects or assists finance team on those issues as needed (i.e. revenue recognition per month and final budget reconciliation. * Facilitate internal and external communication and activities on data transfer specification (DTS) development and complete data transfers to data management vendors/sponsors. * Participate in onsite client visits and assist internally in preparation as necessary. Position Requirements: * Bachelor's degree or higher in biological sciences, chemistry, or related discipline. * In-depth knowledge of bioanalytical and/or biologics assays. * Minimum 1-2 years of project management experience in GLP, Pharmaceutical or CRO environment. * Excellent communication and strong client relationship management skills. * Proficient with Excel, Word, PowerPoint and other computer skills. * Good Time Management/ Organizational skills adopting a committed approach to providing a high level of customer service when managing multiple tasks. * Demonstrated professionalism including excellent work ethic, positive attitude and experience communicating with external clients. Salary and Benefits: Frontage Laboratories offer a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Associate Project Manager- Bioanalytical & Biologics Services Reports to: Group Leader, BioA Project Management Full-time Frontage Laboratories: Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Bioanalytical & Biologics Services: At Frontage, we believe that we deliver high quality services through our focus on technical excellence, which enables us to understand and solve complex drug development challenges. Our deep scientific expertise in method development, transfer and validation allows us to provide clients with complex solutions for challenging studies including oncology clinical trials, rare disease assay development and specialty assays Position Summary: -Manage and monitor project progress and timelines to ensure successful completion from start up to end of study. -Participate and communicate effectively in project meetings with clients on a regular basis as well as with cross-functional teams to ensure projects are met with quality and within the applicable scope and budget. -Collaborate with the financial sector throughout various stages of projects (monthly invoices, revenue recognition, and budget final reconciliation). -Support Management and BD team for new business opportunities. -Onsite is required as needed. Position Responsibilities: -Minimizes risks on projects by working closely with the lab operations and lab support teams, PIs, and sponsors to ensure project progress is met for each milestone in accordance with project scope per requested timelines by the sponsor. -Creates, updates and tracks projects in project management tool (QuickBase) daily and generating project trackers and reports as requested. -Leads/participate in project meetings with sponsors on a regular basis or on as needed basis and prepare meeting minutes to ensure alignment of deliverables. -Serves as a liaison between internal departments (scientific staff, QC/TW, QA, SM, etc.) to ensure project timelines are met with quality. -Proactively communicate with clients on project timelines, issues, and updates via phone, e-mails, or TC as necessary. -Requests and reviews invoices per milestone on a rolling basis that are tracked in QuickBase and respond to client's questions related to invoices or finance aspects or assists finance team on those issues as needed (i.e. revenue recognition per month and final budget reconciliation. -Facilitate internal and external communication and activities on data transfer specification (DTS) development and complete data transfers to data management vendors/sponsors. -Participate in onsite client visits and assist internally in preparation as necessary. Position Requirements: Bachelor's degree or higher in biological sciences, chemistry, or related discipline. In-depth knowledge of bioanalytical and/or biologics assays. Minimum 1-2 years of project management experience in GLP, Pharmaceutical or CRO environment. Excellent communication and strong client relationship management skills. Proficient with Excel, Word, PowerPoint and other computer skills. Good Time Management/ Organizational skills adopting a committed approach to providing a high level of customer service when managing multiple tasks. Demonstrated professionalism including excellent work ethic, positive attitude and experience communicating with external clients. Salary and Benefits: Frontage Laboratories offer a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

About Summit Summit Therapeutics Inc is a biopharmaceutical oncology company with a mission focused on improving quality of life increasing potential duration of life and resolving serious unmet medical needs At Summit we believe in building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology Summit has multiple global Phase 3 clinical studies including Non small Cell Lung Cancer NSCLC HARMONi Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who were previously treated with a 3rd generation EGFR TKI HARMONi 3 Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLC HARMONi 7 Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLC Colorectal Cancer CRC HARMONi GI3 Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration NMPA Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland Overview of Role The Associate Director of Project Management sits within the Program Management and Business Strategy department and is pivotal in contributing to a fit for purpose PMO and driving cross functional execution and operational excellence across oncology development programs particularly Phase 2 and beyond The Associate Director will serve as a strategic integrator aligning corporate and clinical development goals with functional execution across departments such as Clinical Operations Development Biometrics Regulatory Clinical Pharmacology Biomarker Strategy Bioanalytical New Indication Planning Quality IT and Compliance This role will be responsible for building and refining infrastructure and processes that support scalable transparent and adaptive program execution This includes dashboarding process improvement and continuous monitoring to ensure visibility accountability and agility as the organization grows and our pipeline evolves Role and Responsibilities Project ManagementDevelop integrated project plans timelines and templates from scratch tailored to program cross functional and governance needs Drive execution of project milestones proactively identifying risks and mitigation strategies Ensure alignment between functional execution and strategic program goals Lead and manage ad hoc cross functional workstreams on specific initiatives Functional IntegrationServe as a project management strategic liaison to 12 functional departments eg Clin Ops Biometrics Clinical Quality Clin DevTranslate functional needs into actionable infrastructure and project plans Support functional teams in achieving operational excellence and compliance Process Improvement & PMO development Design and implement scalable adaptable processes that support program execution Lead initiatives to improve operational efficiency transparency and agility Ensure all infrastructure initiatives are documented and integrated into the PMO library Apply continuous monitoring and feedback loops to refine processes as the organization evolves Dashboarding & VisibilityDevelop and maintain dashboards using Smartsheets and other tools to track timelines deliverables and risks Ensure real time visibility into project status for leadership and stakeholders Champion data driven decision making through effective reporting and visualization Leadership & CollaborationNavigate ambiguity with confidence and clarity Be a self starter while knowing when to seek input and guidance Lead diverse teams in both direct and matrixed environments Foster strong relationships across functions and levels of the organization All other duties as assigned Experience Education and Specialized Knowledge and Skills EducationMinimum of a Bachelors degree preferably in a scientific or business discipline Masters degree preferred ExperienceMinimum of 8 years in a pharmaceutical company or CRO Direct experience in oncology drug development Phase 2 and beyond Expertise in drug development financial operations and strategic planning Strong project management experience PMP certification preferred Experience leading diverse teams in direct and matrixed environments Technical SkillsProficiency in Smartsheets and dashboarding tools Experience with systems such as Veeva SAP CTMS Janus Power BI highly preferred Solid understanding of financial aspects of clinical operations Prior experience in resource planning capacity management and project baselining highly preferred Ability to derive key insights on complex topics and deliver verbal and written communications accordingly Core CompetenciesEffective leadership and team building skills Excellent communication analytical and conceptual skills Strong planning and organizational abilities with a focus on results Performance driven with the ability to lead and deliver in complex environments Skilled in recommending and implementing process improvements Capable of managing multiple projects simultaneously The pay range for this role is 153000 180000 annually Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location This may be different in other locations due to differences in the cost of labor The total compensation package for this position may also include bonus stock benefits andor other applicable variable compensation Summit does not accept referrals from employment businesses andor employment agencies in respect of the vacancies posted on this site All employment businessesagencies are required to contact Summits Talent Acquisition team at recruitingsmmttxcom to obtain prior written authorization before referring any candidates to Summit

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. The Group also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description Role Overview The GMP Testing Project Manager is responsible for planning, coordinating, and overseeing Good Manufacturing Practice (GMP)-compliant testing projects within a regulated laboratory environment. This role ensures timely delivery of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal teams and external clients. Key Responsibilities Project Management Lead and manage multiple GMP testing projects from initiation to closure. Establish and maintain comprehensive tracking tools for projects, including schedules, action trackers and dashboards to enforce accountability and timely delivery. Monitor progress, identify risks, and implement mitigation strategies. Ensure all deliverables meet client expectations and regulatory requirements. Prepare and present project updates and reports to internal and external stakeholders. Track, manage and report turnaround time metrics and schedule variance. Client Communication Serve as the primary point of contact for clients, ensuring clear communication and accurate interpretation of technical data across functional teams. Organize and facilitate planned and ad hoc project meetings including: project kick off, recurring project status calls, client technical visits, and project closure meetings. Prepare and present project status and performance KPIs in client Business Review Meetings. Financial Management Work closely with the Business Development team to grow client relationship and revenue through cross selling and managing assigned projects to provide exemplary customer experience and value Track financial performance - including FTE utilization, planned vs actual hours, budget variance, and cash flow. Compliance & Quality Ensure testing activities comply with GMP, GLP, and relevant regulatory guidelines. Maintain accurate documentation in accordance with Quality Management Systems (QMS). Support audits and inspections by regulatory authorities and clients. Drive investigations to timely closure. Team Collaboration Collaborate with cross-functional teams (Operations, QA, Sample Registration, Pricing, Business Development). Collaborate with partner Eurofins sites and subcontractors as required. Qualifications Education: Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field Experience: Strong background in pharmaceutical sciences, analytical chemistry, or biologics. Experience in GMP lab operations, especially in CMC testing. Proven ability to manage complex projects and cross-functional teams. Familiarity with regulatory requirements and quality standards. Excellent communication and client management skills. Skills: Knowledge of GMP regulations (21 CFR Part 210/211, EU GMP). Excellent organizational and time-management skills. Proficiency in project management tools (MS Project, Smartsheet). Strong communication and stakeholder management abilities. Authorization to work in the United States indefinitely without restriction or sponsorship Additional Information Position is full-time, Monday-Friday, 8:00 a.m.-4:00 p.m. with additional hours, as needed. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply. We offer excellent full-time benefits including: comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, dental and vision options. Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

at Havas Health & You .

The eCaseLink Associate Project Manager will assist the eCaseLink Project Manager in the project management of the capture and maintenance of clinical data, from setup to completion of a clinical trial. Major responsibilities include project documentation, customer communications, timeline tracking, and project schedules. As a successful candidate, you will need to meet the following technical requirements and qualifications: * Bachelor's Degree or equivalent experience. * Pharmaceutical industry experience a plus. * Strong management references required. Description of Duties and Responsibilities: * Act as a liaison with Clinical Project Managers and Clinical Data Managers at top pharmaceutical companies, taking projects for clinical trials from start to completion. * Ensure client expectations are met as well as developing plans in order to meet client's production data. * Ensure the quality of DSG software products, solutions, and deliverables in order to meet client expectations . * Organize and run project maintenance meetings at the discretion of the eCaseLink Project Manager. * Assist in the organization, direction and coordination of both internal and external teams on a daily basis. * Creation and review of the EDC screens and system edits specification that outlines data field requirements and appropriate edits. * Creation and review of project specific eCaseLink system specifications based on client requirements. * Review all project specific documentation (validation documentation, system specifications, etc.) prior to delivery to eCaseLink Project Manager. * Assist in edit specification testing and project specific system validation as needed. * Familiarity with the clinical trial process. * Working knowledge of application design and the development process. * Assist the eCaseLink Project Manager with training and support to end users. * Assist in the verification of eCaseLink product releases. * ePro experience is helpful. * Other duties as necessary. Minimum Required: * Bachelors Degree or equivalent experience. * Pharmaceutical industry experience a plus. * Strong management references required. If you meet these requirements and enjoy a fast paced environment and want to join a great team, we encourage you to apply.