Premier Research jobs - 62 jobs

Premier Research is looking for a Senior Vice President, Regulatory and Product Strategy to join our Regulatory Affairs team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What You'll Be Doing: Lead integrated Regulatory Strategy, Regulatory Affairs, Commercial Strategy, and Clinical Development Strategy services to meet client needs. Drive organizational design and development, including building a contractor network to complement in-house capabilities. Monitor industry trends and implement plans to achieve revenue and margin growth aligned with corporate goals. Foster strong collaboration across consulting and clinical development functions to ensure client service excellence. Oversee operational performance, budgets, and proposal templates to maintain consistency and profitability. Represent the organization with regulatory agencies and in the scientific community while maintaining compliance knowledge globally. What We Are Searching For: Advanced degree in a science-related field (PharmD or PhD preferred) and 20+ years in pharma, CRO, or biotech, including 10+ years of leadership experience. Proven expertise in regulatory submissions support for US and Europe, plus IND applications and product approvals. Strong financial acumen with experience managing budgets and driving business development. In-depth knowledge of global drug development regulations, including clinical, pre-clinical, and manufacturing requirements. Remote based opportunity, however priority consideration for those physically located in San Francisco or Boston. Demonstrated ability in complex reasoning, risk management, and strategic decision-making. Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $290,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off. #LI-TW1 Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status

The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve. Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients. **Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading obesity global studies.** Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior role of Senior Project Leader. To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills. \#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.

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. Title: Principal Real World Research Delivery Lead (RWRDL) Location: US - Remote Are you ready to take on a challenge and accelerate your career? This is an excellent opportunity for a self-driven, autonomous leader eager for growth and progression. Parexel is seeking a Principal Real World Research Delivery Lead (RWRDL) to join our team and deliver innovative Real World Research (RWR) solutions for global clients. This is a great opportunity to join our team as a senior leader driving Real World Research (RWR) solutions for global clients. In this role, you'll lead cross-functional teams, manage budgets and timelines, and serve as the primary client contact for innovative RWD projects. We're looking for a strategic project leader with strong communication skills, adaptability, and a go-getter mindset. Experience in RWD/RWE, data privacy, and drug development is a plus. Career Growth: Shape new services, mentor emerging leaders, and gain visibility in a lean PM model. As a senior leader, you will: Lead cross-functional teams and act as the primary client contact for complex RWR and RWD projects. Oversee project proposals, budgets, timelines, and milestones while ensuring compliance with SOPs and data privacy standards. Collaborate with multidisciplinary teams to design and implement RWR-enabled solutions. Mentor junior team members and help shape new services in a lean PM model. What We're Looking For: Strong project leadership experience with proven ability to manage multiple projects and decentralized teams. Excellent communication skills, adaptability, and a proactive, go-getter mindset. Knowledge of RWD/RWE methodologies, data privacy, and drug development processes. Ability to thrive in dynamic environments and lead independently. Preferred Experience: RWD/RWE expertise, commercial experience, and familiarity with late-phase clinical research. Understanding of RWD platforms, project management systems, and GCP environments. Education: Bachelor's degree in a science or clinical-related field; Prince II or AMPM certification preferred. Why Join Us? Career progression and visibility in a growing RWD space. Opportunity to develop new services and mentor emerging leaders. Work on impactful projects that shape the future of clinical research. If you're ambitious, adaptable, and ready to make a difference, apply today and lead the way in Real World Research! 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.

**Parexel is hiring an FSP** **Consultant, Advanced Analytics: Meta-Analysis (HTA Statistician)** **to work remotely. Must be able to accommodated East Coast/CET hours. The ideal candidate will have key experience in** **NMA/Evidence Synthesis, Survival analysis, and HTA experience.** **Location: US -** Remote | **Employment Type:** Full-Time **Job Purpose** The Statistician, **Consultant, Advanced Analytics: Meta-Analysis,** contributes statistical capabilities and methodological leadership at all stages of projects, from planning to completion. The role involves working with junior team members to design, develop, and deliver client solutions across multiple projects-leveraging competencies in **statistical theory, data analysis and interpretation, regression analysis, systematic review, and evidence synthesis methodologies** . The individual must have a **Master's or Doctoral Degree** in **Health Economics, Health Policy, Statistics, Biostatistics, Mathematics** , or other quantitative fields. Proficiency in **data analytics and statistical software/tools** such as **WinBUGS, R, Stata, Python, and SAS** is required. **Key Accountabilities** + Provide expert input on the design of clinical development programs to ensure Access/HTA evidence needs are considered within global development and commercialization strategies. + Identify evidence gaps, possible data sources, and design and implement robust evidence-generation plans. + Ensure Access/HTA evidentiary activities are strategically aligned with other functions within Global Access and the wider organization (affiliates, Product Development, commercial, etc.). + Plan and conduct statistical analyses of clinical trials and other relevant data sources and develop supporting technical documentation for statistical analyses and economic models. + Interpret and communicate the findings of analyses and work closely with affiliates to incorporate global statistical and health economics input into their local reimbursement applications. + Lead or contribute to cross-functional teams within a matrix structure and actively contribute to the development of methodologies and continuous improvement within the Evidence Chapter. + Keep up to date with the changing Access/HTA landscape and academic research to ensure current access trends and methodologies are incorporated into evidentiary plans and build relationships with relevant external statistics, health economics, Access/HTA, and policy experts. **Additional Responsibilities** The Consultant is responsible for ensuring that all assigned projects are conducted efficiently and that **quality and client satisfaction** are maximized-ensuring project direction and deliverables meet objectives and client needs. Consultants are expected to guide **Senior Associates and Associates** in their daily duties and flag any areas of acute training needs to their line managers. Supported by senior staff and Business Development partners, the Consultant is responsible for maintaining client relationships on their projects. Candidates will be part of **multi-disciplinary research teams** and will provide statistical expertise and methodological leadership at all stages of projects from planning to completion. Duties may include: + Preparing network meta-analysis protocols + Reviewing data extracted from systematic literature reviews + Conducting feasibility assessments + Generating network diagrams + Critically assessing study heterogeneity + Conducting network meta-analysis + Assisting with interpretation and dissemination of findings The candidate is also expected to support **thought leadership and innovation objectives** in advanced analytics, including but not limited to: + Pairwise meta-analysis + Mixed treatment comparison + Indirect treatment comparison + Network meta-analysis + Match-adjusted indirect treatment analysis + Meta-regression + Single-arm trial analysis + Simulated treatment comparison + Surrogate outcome assessment **Skills & Qualifications** + **Master's or Doctoral-level degree** in applied statistics, health economics, or related quantitative fields. + Minimum of **3 years of hands-on experience** in the pharmaceutical industry, consultancy, Access/HTA/reimbursement agency, or academic institution (pharma affiliate experience is a plus). + In-depth knowledge of **Access and HTA** , clinical research and development methods, and international payer evidence requirements. + Skilled in research design and statistical methods, such as **Generalized Linear Models, Survival Analysis, Network Meta-Analysis, and Bayesian statistics** . + Proficient in **R** and **GitLab** (experience with SAS, Python, WinBUGS, JAGS, or other relevant statistical software is a plus). + Strong strategic, collaboration, and communication skills; excellent organization, planning, and prioritization abilities; ability to meet tight deadlines; and strong written and verbal communication skills in English. \#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.

We are looking to fill a microbiologist position (environmental monitoring focus) working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. **Qualifications** + Bachelor's degree required; concentration in a scientific or applied discipline strongly preferred + A minimum of two years of experience in pharmaceutical microbiology related position required (occasional overtime) **Required Skills and Experience** + Experience in working in a GMP Pharmaceutical environment with specific experience environmental monitoring + Proven technical writing skills (SOPs, protocols) **Responsibilities** ENVIRONMENTAL MONITORING + Proficiency in the pharmaceutical microbiology laboratory workflow for EM collection and testing, reporting and trending + Sampling EM rooms, surface and air + Collection and testing water samples + Weekly water trends- visually to be able to report back to the source area + Equipment responsibilities with metrology oversight, automation, etc + MODA USE + Responsible for writing annual reports + Responsible for writing trend reports + Able to clearly interpret adverse vs desirable data + Mold investigations and studies + PSIM work + Biological indicator analysis and certification + Disinfection studies where appropriate + Critical thinking with data MICROBIOLOGICAL PRODUCT ANALYSIS + Analyze samples and compile meaningful data + Perform Investigations and prepare/respond to CAPA + Review, revise Test Procedures/Standard Operating Procedures + Ad Hoc work + Rotational on-call assignments for responding to alarms MICROBIOLOGICAL ACTIVITIES Include (but not limited to): + Receive, verify & Log in samples + Return templates and shipping paperwork when and where appropriate + Prepare and ship materials offsite for ID/testing (when applicable) + Stock culture management and quality control of same + Biological indicator management + Bioburden testing + Water sampling + Microbiological media management and quality control of same + Sterilization activities + Research experiments as deemed appropriate by client management + Method Validation/Qualification + Other microbiological activities CALIBRATIONS: + Execute "Before-Use" calibrations prior to performing testing + Review calibration data within the ELN + Prepare and submit equipment for calibrations (offsite or onsite) + Complete calibration/PM paperwork GMP ACTIVITIES: + Prepare GMP documentation as requested by management + Perform laboratory sanitizations and ensure cleanliness of laboratory workspace + Perform equipment sanitizations (incubators / hoods / refrigerators) + Purchase supplies (GMP) + Prepare and send documents to Records Center INVESTIGATIONS: + Initiate, facilitate, and perform Investigations and NOEs (Notice of Event-NOE) for Environmental samples [NOE for Microbiological Environment Event (MEN)] + Inform management of non-conforming events AUDITS: + Participate in audits (Regulatory, In-house, Corporate) + Participate in self-inspections and safety inspections + Retrieve data when requested by Microbiology management TRAINING: + Complete assigned training when required + Ensure training is complete prior to performing tasks + The role is intended to be a 40-hour-per-week position. **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! \#LI-DK1 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. Internal Job Title: Research Associate (CPT license required) Work location: onsite in Glendale, CA Shift: Flex - predominantly work the day shift but must be able to flex to work evening shifts starting after 3:00pm when business requires. 2 to 3 weekend shifts required. Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. At Parexel Glendale, CA unit our highly trained and skilled Research Associates are crucial to ensuring the successful completion of Phase I trials. This is a great role for anyone that aspires to be an enrollment specialist, clinical research coordinator, or eventually manager. Parexel provides a great system of support to help you grow and advance your career internally. Parexel comes along with an extensive induction program and ongoing training while following your individual career path. What you'll do after training is completed (including but not limited): You will understand study protocols and be able to complete required medical procedures. Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments. Enter study participants in the study participant tracking system and study logs, maintain appointment calendars, and operate company information systems and computer programs. Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results. Prepare/monitor study supplies and stock levels in clinic/hospital. Label, inventory, and send plasma samples. Problem solves study participant issues as they arise. Ensure basic study participant safety is provided. Assist with Monitor visits (i.e., room set up, etc.). Identify issues that need Sponsor approval and bring these to the attention of the CRC. Maintain and update knowledge of Clinical Operating Guidelines and their proper application. Assume appropriate role with study participants and caregivers. Assure quality and accuracy of source and CRF documentation. Comply with Quality Management (QM) department guidelines and perform corrections for QM, CRC and Monitor/Sponsor Representative in a timely manner. Your Profile: Customer service experience in a fast-paced environment Clinical Research experience or patient experience is required B.S.+ in related life science field OR HS diploma or GED with experience Comfortable standing and walking for a prolonged period of time Certified Phlebotomy Technician I License is required Base Pay Range: $20.00 to $26.00 per hour Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. 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. Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do. Job Title: Investigator Financial Analyst II Job Introduction: At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking an Investigator Financial Analyst II to join our team. As an Investigator Financial Analyst, you'll be joining a fast-paced, driven environment that's helping to make life-changing differences to patients by steering the investigator budget management for crucial projects. Through the collaboration and diversity of the Investigator Payment Division the Investigator Financial Analyst is provided with opportunities to excel and discover where your skills can take you. Who we are looking for: Curious individuals interested in understanding investigator budget economic drivers. Who are detailed-oriented while assisting in translating the clinical conduct into a financial impact and proactively advising the project leader and the project financial analyst on how to influence critical budget and cash flow levers to prevent negative impact project financials. What you'll do: Lead the monthly investigator payment forecast cycle and support project analysis requirements, including a review of accruals, costs incurred, contracts signed, and patients enrolled. Collaborate with clients, clinical team members, and other members of the organization to gather information and/or explain the financial impact of the observed clinical conduct. Manage all required variance analyses for the set of projects, with insight and identify risks in the project forecast and to the budget. Present updates on financial status of investigator payments for assigned projects and create information in response to client financial reporting needs for assigned projects in the area of project reporting, forecasting, or transactional details for the projects within the portfolio. Why join us: Be part of groundbreaking projects that are pushing the boundaries of the industry. Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities. Enjoy work life balance and flexible working hours. Parexel US Benefits: Health, Vision & Dental Insurance Tuition Reimbursement Vacation/Holiday/Sick Time Flexible Spending & Health Savings Accounts Work/Life Balance 401(k) with Company match Pet Insurance Full list of benefits available here: *********************************** About Parexel International: At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you're exposed to a world of experiences and open doors. If this job does not sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply! 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. Job Title: Research Associate - fluent in Japanese Work Location: onsite in Glendale, CA Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. At Parexel Glendale, CA unit our highly trained and skilled Research Associates are crucial to ensuring the successful completion of Phase I trials. This is a great role for anyone that aspires to be an enrollment specialist, clinical research coordinator, or eventually manager. Parexel provides a great system of support to help you grow and advance your career internally. Parexel comes along with an extensive induction program and ongoing training while following your individual career path. What you'll do after training is completed (including but not limited): You will understand study protocols and be able to complete required medical procedures. Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments. Enter study participants in the study participant tracking system and study logs, maintain appointment calendars, and operate company information systems and computer programs. Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results. Prepare/monitor study supplies and stock levels in clinic/hospital. Label, inventory, and send plasma samples. Problem solves study participant issues as they arise. Ensure basic study participant safety is provided. Assist with Monitor visits (i.e., room set up, etc.). Identify issues that need Sponsor approval and bring these to the attention of the CRC. Maintain and update knowledge of Clinical Operating Guidelines and their proper application. Assume appropriate role with study participants and caregivers. Assure quality and accuracy of source and CRF documentation. Comply with Quality Management (QM) department guidelines and perform corrections for QM, CRC and Monitor/Sponsor Representative in a timely manner. Your Profile: Customer service experience in a fast-paced environment Experience working in a medical or clinical setting is highly preferred Comfortable standing and walking for a prolonged period of time B.S.+ in related life science field OR HS diploma/GED with relevant experience Fluent in Japanese Hours/Shift - all shifts are onsite (no remote work) **please note this is not a full-time opportunity we are currently seeking per diem candidates (this role is not eligible for full time benefits). Required Training: two weeks working 40 hours a week Mon - Fri 8:00am to 4:30pm Post training requirements: Employees must provide, at minimum, full-day availability to work any shift between 5:00 AM and 12:00 AM three days a week, with one of those days being Sunday. Additional availability is strongly recommended when possible. Can be scheduled up to 8 hours per day & 40 hours per week; but hours are not guaranteed and will vary based on business needs Base Pay Range: $20.00 to $26.00 per hour (this role is eligible for shift differentials) Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. 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. Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. At the Parexel Glendale, CA Early Phase Clinical Unit the Clinical Scheduling Coordinator, plays a critical role in ensuring efficient and effective scheduling of clinical trials by working closely with cross-functional teams to ensure seamless coordination and execution of study timelines. If you thrive in a fast-paced environment, have strong organizational skills, and enjoy collaborating with diverse teams, this position is perfect for you. Please note: this role is 100% onsite at our Glendale, CA unit (no remote work) What you'll do after training is completed (including but not limited): Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and all work processes to ensure the efficient and compliant operation of the EPCU. Provides help in designs for EPCU clinical staffing schedules to rationally meet the demands of workflow processes in the EPCU and creatively minimize any unnecessary overtime scheduling. Assist clinical teams in performing study procedures when necessary Provide administrative assistance in maintenance of study flow sheets and staffing schedule. Work with study coordinators in identifying staff needs of assigned protocols. Assigns tasks and clinical procedures to appropriately trained research nurses, research assistants, research associates, research technicians, laboratory technicians (if applicable). Supports introduction of new technologies and equipment for efficient operations. Participates in the fiscal objectives of the unit and recognizes cost reduction opportunities. Exemplify guest and staff relations standards in all activities. Attend study specific training and staff training on protocols, GCP guidelines, treatment, possible side effects and participant safety. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and is not to be considered as all-inclusive. Your Profile: At least 2-3 years related experience in clinical research coordination Experience developing and implementing strategies to optimize scheduling efficiency and resource utilization highly preferred Computer skills; ability to use MS Word, Excel, Power Point and Outlook Education: BS/BA preferred Base Pay Range: $25.00 to $30.00 hourly Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. Parexel is dedicated to supporting, developing, and retaining a diverse workforce, inclusive of veteran and military spouse talent. The skills and values you have developed are transferrable to meaningful careers at Parexel. 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. The Manager, Data Analysis, is responsible for overseeing centralized monitoring activities for global and/or complex clinical trials, ensuring the effective configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) systems. This role involves configuring studies within an RBQM platform, performing recurring data refreshes, troubleshooting errors in execution, and leveraging programming expertise to support advanced data analyses, automation, and reporting. The Manager will play a critical role in interpreting and presenting Key Risk Indicator (KRI) and Key Performance Indicator (KPI) data, as well as conducting comprehensive reviews of supplemental operational data, trends, and issues. Proficiency in programming languages such as R, SQL, or SAS will be essential for creating custom analyses, automating workflows, and integrating data systems. As an integral member of the Central Monitoring team, the Manager will deliver actionable insights to drive decision-making and optimize trial performance. Additionally, the Manager will oversee multiple studies within a designated therapy area, lead process improvement initiatives, and contribute to innovation in central monitoring capabilities through collaboration with cross-functional teams and industry partners. This role requires a combination of technical expertise, analytical problem-solving skills, and effective communication to succeed in a dynamic, fast-paced environment. Job Duties: Act as a subject matter expert for the configuration, implementation, and execution of Central Monitoring RBQM system across studies. Maintain Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries within Central Monitoring RBQM system to ensure standard deployment consistency and alignment with regulatory requirements. Coordinate with functional and cross functional stakeholders to develop configuration specifications for Central Monitoring in RBQM system. Provide operational expertise, training, and guidance as a point of escalation for Central Monitoring issues related to Central Monitoring RBQM system. Conduct central monitoring reviews in support of study central monitor. Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials that support Central Monitoring and RBQM. Represent Central Monitoring in process improvement initiatives. May require 25% travel. Job Requirements: At least 4 years of relevant biotechnology/pharmaceutical industry experience. Central Monitoring, site monitoring or data management experience a plus. Minimum 2 years with direct RBQM systems experience. Technical expertise in database design, system configuration, and report development, with experience in managing Risk-Based Quality Management (RBQM) systems or similar platforms. Proficiency in programming languages such as Python, R, SQL, or SAS, with the ability to develop scripts for data analysis, automation, and system integration. Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements. Aptitude for mathematical concepts, statistical methodologies, and data analytics, with a focus on interpreting Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs). Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures. Proficiency in Microsoft Office applications, with advanced skills in Excel for data manipulation and reporting. Preferred: Experience using CluePoints or similar centralized monitoring and risk-based quality management solutions. #LI-LO1 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.

Premier Research is looking for a Regulatory Strategy Associate to join our Regulatory Affairs team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What you'll be doing: Independently prepare IND Modules for routine submissions. Support regulatory affairs leadership in preparation of complex submissions, using regulatory intelligence to support regulatory strategies and other regulatory deliverables (e.g., Orphan Designation Applications, Fast Track and Breakthrough Designations, Briefing Packages, etc.). Perform thorough independent background research through all pertinent search engines for further in-depth research efforts related to medical and regulatory documents, filings, and/or submissions. Ensure that documents appropriately evaluate and present data and methodology, accurately reflecting the information provided in scientific literature available in the public domain. Navigate and obtain information for projects from all available resources. Produce timely, scientifically accurate data summaries, ensuring documents are appropriate for inclusion in final reports and submissions to client and/or FDA. Construct documents in a manner consistent with applicable regulations and guidance and client strategic intent, conforming to Premier Consulting's internal Standard Operating Procedures (SOPs). Serve as Regulatory representative in department discussions and present issues, challenges, and potential solutions accordingly. Interface with international affiliates on regional regulatory strategy and implementation plans. What we are searching for: Preferred location: Bay Area or Boston Master's degree, or international equivalent from an accredited institution, in a science or health related field; PhD or PharmD preferred. 2+ years of experience working in a CRO, pharmaceutical biotechnology, consulting, regulatory affairs, or device/diagnostics industry; industry experience may be considered in lieu of an advanced degree and a post advanced degree fellowship may be considered in lieu of industry experience. Strong scientific verbal and writing skills. Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously. Ability to communicate and interact effectively within the department, across departments and on project team(s). We are unable to support VISA sponsorship now or in the future for this role Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $75,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off. Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or 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. During the last five years, Parexel has participated in more than 1,000 Oncology and Hematology clinical projects. The range of services includes compound clinical development planning, collaboration with feasibility, protocol writing or optimization, medical monitoring and pharmacovigilance. Parexel has global presence in every phase of clinical research and expertise in virtually every indication and mechanism of action, including novel Immuno-oncology agents, cellular based therapy, and cancer stem cell targeted treatment. Join our growing team of Oncologists/Hematologists and make a difference in the lives of patients searching for more effective and better tolerated cancer therapies. Parexel's continued success has positioned us for significant North American growth in the coming year. As we prepare for this expansion, we're seeking to connect with Board-Certified Oncologists who are passionate about advancing clinical research and interested in learning more about the Medical Director role. As a Medical Director at Parexel, you will provide medical monitoring for assigned projects, function as medical representative on the project team, provide medical consultation as required or requested to client/sponsor or to other Parexel service groups, and assume the role of Senior Technical Lead in selected circumstances. In addition, you will also: Review all individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness. Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis, summarizing adverse experiences as required by FDA or the sponsor, depending on the contract. Review data listings of safety data, including adverse experiences, laboratory data, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate with the project team, sponsor, investigator, and FDA. Review documents written by various Parexel divisions for safety issues. Review coding of adverse events and concomitant medications for accuracy and consistency. Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors or in conjunction with clients/sponsors and in conjunction with other Parexel divisions. Attend and present material, as requested, at meetings within Parexel as well as extra-company external meetings and conferences Successful applicants will be medically qualified based on successful completion of training at an accredited medical school and be US or Canada Board-certified in Oncology with experience in adult or pediatric clinical patient care. Past experience as a Medical Monitor, Physician in Industry, or as a Clinical Trial Primary Investigator or Sub-Investigator is highly preferred. Successful applicants will also have: Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts. Excellent time management skills Excellent verbal and written medical communication skills Excellent standard of written and spoken English A flexible attitude with respect to work assignments and new learning The ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. A willingness to work in a matrix environment and to value the importance of teamwork. The ability to travel 10% domestically and/or internationally as needed. 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.

in Cincinnati, OH. Responsibilities * Write statistical programs for use in creating analysis datasets, tables, listings & figures; * Lead programming activities for one or more studies; * Review analysis plans for appropriate methodologies; * Program study analysis & review study results; * Communicate project requirements for cleanup & data capture to ensure the key study variables are suitable for analysis; and * Supervise junior-level Statistical Analysts. * Remote work may be allowed approximately 40% of the time. Qualifications * Master's degree in Statistics, Biostatistics or related field (foreign equivalent degree accepted). * 2 years of experience as a Statistical Analyst or closely related. * 2 years of experience with each of the following: * SAS and/or statistical programming; * Databases & data management process; * Statistical methods commonly used in pharmaceutical clinical trials; * Pharmaceutics/Biotech/CRO clinical trials study analysis; * Drug development & regulatory requirements; * SAS programming/analysis skills; * CDISC SDTM/ADaM requirements; and * Clinical trial data management terminologies/processes. Experience may be gained concurrently. Apply online at: **************** No calls. 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 4,000 people across almost 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.

Join our CRA Team in Cincinnati, Ohio! The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with PhD/Life Science backgrounds who want to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you! MEDPACE CRA TRAINING PROGRAM (PACE ) No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence: * PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA. * PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums. * To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process. WHY BECOME A CRA This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including: * Dynamic working environment, with varying responsibilities day-to day * Expansive experience in multiple therapeutic areas * Work within a team of therapeutic and regulatory experts * Defined CRA promotion and growth ladder with potential for mentoring and management advancements * Competitive pay and many additional perks unmatched by other CROs (SEE BELOW). WE OFFER THE FOLLOWING * Competitive travel bonus; * Equity/Stock Option program; * Training completion and retention bonus; * Annual merit increases; * 401K matching; * The opportunity to work from home; * Flexible work hours across days within a week; * Retain airline reward miles and hotel reward points; * Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere; * In-house travel agents, reimbursement for airline club, and TSA pre-check; * Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more; * CRA training program (PACE ); * Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts; * In-house administrative support for all levels of CRAs; and * Opportunities to work with international team of CRAs. Responsibilities * Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; * Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; * Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; * Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; * On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; * Verification that the investigator is enrolling only eligible subjects; * Regulatory document review; * Medical device and/or investigational product/drug accountability and inventory; * Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; * Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and * Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications * Must have a minimum of a Bachelor's degree in a health or life science related field; * Ability to travel 60-70% to locations nationwide is required, or less if remote/virtual visits required; * Must maintain a valid driver's license and the ability to drive to monitoring sites; * Minimum 1 year healthcare-related work experience preferred; * Proficient knowledge of Microsoft Office; * Strong communication and presentation skills; and * Must be detail-oriented and efficient in time management. 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.

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.

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. Parexel is hiring an FSP Consultant, Advanced Analytics: Meta-Analysis (HTA Statistician) to work remotely. Must be able to accommodated East Coast/CET hours. The ideal candidate will have key experience in NMA/Evidence Synthesis, Survival analysis, and HTA experience. Location: US - Remote | Employment Type: Full-Time Job Purpose The Statistician, Consultant, Advanced Analytics: Meta-Analysis, contributes statistical capabilities and methodological leadership at all stages of projects, from planning to completion. The role involves working with junior team members to design, develop, and deliver client solutions across multiple projects-leveraging competencies in statistical theory, data analysis and interpretation, regression analysis, systematic review, and evidence synthesis methodologies. The individual must have a Master's or Doctoral Degree in Health Economics, Health Policy, Statistics, Biostatistics, Mathematics, or other quantitative fields. Proficiency in data analytics and statistical software/tools such as WinBUGS, R, Stata, Python, and SAS is required. Key Accountabilities Provide expert input on the design of clinical development programs to ensure Access/HTA evidence needs are considered within global development and commercialization strategies. Identify evidence gaps, possible data sources, and design and implement robust evidence-generation plans. Ensure Access/HTA evidentiary activities are strategically aligned with other functions within Global Access and the wider organization (affiliates, Product Development, commercial, etc.). Plan and conduct statistical analyses of clinical trials and other relevant data sources and develop supporting technical documentation for statistical analyses and economic models. Interpret and communicate the findings of analyses and work closely with affiliates to incorporate global statistical and health economics input into their local reimbursement applications. Lead or contribute to cross-functional teams within a matrix structure and actively contribute to the development of methodologies and continuous improvement within the Evidence Chapter. Keep up to date with the changing Access/HTA landscape and academic research to ensure current access trends and methodologies are incorporated into evidentiary plans and build relationships with relevant external statistics, health economics, Access/HTA, and policy experts. Additional Responsibilities The Consultant is responsible for ensuring that all assigned projects are conducted efficiently and that quality and client satisfaction are maximized-ensuring project direction and deliverables meet objectives and client needs. Consultants are expected to guide Senior Associates and Associates in their daily duties and flag any areas of acute training needs to their line managers. Supported by senior staff and Business Development partners, the Consultant is responsible for maintaining client relationships on their projects. Candidates will be part of multi-disciplinary research teams and will provide statistical expertise and methodological leadership at all stages of projects from planning to completion. Duties may include: Preparing network meta-analysis protocols Reviewing data extracted from systematic literature reviews Conducting feasibility assessments Generating network diagrams Critically assessing study heterogeneity Conducting network meta-analysis Assisting with interpretation and dissemination of findings The candidate is also expected to support thought leadership and innovation objectives in advanced analytics, including but not limited to: Pairwise meta-analysis Mixed treatment comparison Indirect treatment comparison Network meta-analysis Match-adjusted indirect treatment analysis Meta-regression Single-arm trial analysis Simulated treatment comparison Surrogate outcome assessment Skills & Qualifications Master's or Doctoral-level degree in applied statistics, health economics, or related quantitative fields. Minimum of 3 years of hands-on experience in the pharmaceutical industry, consultancy, Access/HTA/reimbursement agency, or academic institution (pharma affiliate experience is a plus). In-depth knowledge of Access and HTA, clinical research and development methods, and international payer evidence requirements. Skilled in research design and statistical methods, such as Generalized Linear Models, Survival Analysis, Network Meta-Analysis, and Bayesian statistics. Proficient in R and GitLab (experience with SAS, Python, WinBUGS, JAGS, or other relevant statistical software is a plus). Strong strategic, collaboration, and communication skills; excellent organization, planning, and prioritization abilities; ability to meet tight deadlines; and strong written and verbal communication skills in English. 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.

Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine. Will work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries. Additional responsibilities include overall project management in alignment with the core business strategy. **Operations Management** Study Team Support + Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders, such as working with Informed Consent Form (ICF) specialist in SKDL on ICF and other trial documents impacting samples and testing Operational Support of Sample Analysis (including exploratory analysis) + Establishment, oversight, planning, and integration of all issues related to collection, processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations + Liaises with Precision Medicine Strategy Leads and other scientists by assessing vendors, forecasting sample operational costs, timelines and reviewing invoices to ensure alignment with budget plans Data Acquisition and Management + Works closely with data management lead to determine how sample and testing data will be captured, blinded and transferred for clinical trials Human Sample Management Flow and Compliance + Provides guidance to clinical teams and clinical sites regarding collection, storage, and shipping of samples acquired in the course of clinical trials or other human sample acquisition projects + Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF + Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed **Compliance with Parexel Standards** + Complies with required training curriculum + Completes timesheets accurately as required + Submits expense reports as required + Updates CV as required + Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery **Skills:** - Excellent written and verbal communication skills - Resolve problems spontaneously and possess strong project management and organizational skills - Work independently and proactively while still contributing to group initiatives and goals - Good interpersonal skills and ability to work with many different groups/teams - Microsoft applications **Knowledge and Experience** : 6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry. We are seeking a professional with working knowledge of clinical trials and clinical databases. Laboratory sample management experience is a plus. **Education:** Bachelor's degree in a life science, nursing qualification or other relevant experience required. \#LI-LO1 \#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.

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. The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve. Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients. Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading obesity global studies. Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior role of Senior Project Leader. To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills. 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.