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Project Manager I - Cell & Gene Therapy

Syneos Health/ inVentiv Health Commercial LLC

Detroit, MI

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JOB DETAILS
SKILLS
Americans with Disabilities Act (ADA), Biology, Biotech and Pharmaceutical, Budgeting, Cancer, Career Development, Clinical Information Systems, Clinical Trial, Clinical Trial Management, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Data Quality, Detail Oriented, Disease, Documentation, Drug Development, Electronic Data Capture (EDC), Embedded Systems, FDA (Food and Drug Administration), FDA Requirements, GCP (Good Clinical Practices), Gene Therapy, Health Plan, Healthcare, IP (Internet Protocol), Leadership, Maintain Compliance, Mentoring, Monitor Regulations, Needs Assessment, Nursing, Oncology, Performance Metrics, Pharmacy, Problem Solving Skills, Process Improvement, Project Management Software, Project/Program Management, Remote Access, Risk Analysis, Risk Management, Startup, Stock Purchase Plans, Team Player, Time Management, Work From Home
LOCATION
Detroit, MI
POSTED
3 days ago
Project Manager I - Cell & Gene Therapy (Sponsor Dedicated - US Remote; Preference for Los Angeles, CA)Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health* We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.* We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.Job ResponsibilitiesProject Manager I - Sponsor Dedicated (Cell & Gene Therapy)Location: strongly prefer candidates located near our sponsor's Los Angeles office (near Westwood neighborhood/ UCLA campus)Role SummaryWe are seeking a skilled and motivated Project Manager I to join our sponsor-dedicated team supporting high-impact oncology and cell & gene therapy trials, including CAR-T studies. In this role, you will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO-offering the best of both worlds: sponsor collaboration and CRO resources.This position focuses on early-phase trial execution, operational oversight, and cross-functional coordination across global study teams. While remote work is supported, we strongly prefer candidates located near our sponsor's Los Angeles office (near Westwood neighborhood/ UCLA campus) to allow for periodic in-office collaboration and faster integration with the sponsor team.What You Will Do
  • Act as a sponsor-facing project manager, ensuring the successful execution of assigned CAR-T and gene therapy trials from startup through closeout.
  • Lead or support study start-up, site activation, and enrollment, working closely with site monitors, regulatory teams, and contracts personnel.
  • Serve as a key point of contact across internal (CRO) and sponsor teams, facilitating regular communications, status reporting, and governance updates.
  • Coordinate with cross-functional stakeholders to ensure timelines, budgets, and milestones are met, particularly in complex, high-touch studies.
  • Track and manage protocol compliance, CAPAs, and site-level quality indicators; support resolution of audit findings.
  • Ensure inspection readiness and regulatory compliance by overseeing TMF maintenance, data accuracy, and documentation completeness.
  • Manage or contribute to the tracking of low-stability endpoint samples and IP-related processes, ensuring timely lab delivery and site support.
  • Assist with risk identification and mitigation planning, while continuously optimizing trial execution processes.Skills and Experience You Have
    • 2-4 years of clinical trial experience, preferably in a CRO setting, with a focus on oncology, rare disease, or gene-modified cell therapy trials.
    • Prior involvement in CAR-T or other cell therapy studies is highly desirable.
    • Strong familiarity with GCP/ICH guidelines, FDA/EMA regulations, and inspection-readiness standards.
    • Experience working in sponsor-dedicated or embedded roles within a CRO is a plus.
    • Proficiency in clinical systems (e.g., CTMS, EDC, eTMF) and project management tools.
    • Confident in leading sponsor calls, presenting KPIs, and contributing to operational governance.
    • Bachelor's degree in a relevant field (Life Sciences, Nursing, Pharmacy, etc.) or equivalent work experience.
    • Comfortable with remote work but agreeable to occasional in-person collaboration in Los Angeles.Why You Want to Work Here
      • Work sponsor-side, stay CRO-strong: This sponsor-dedicated role offers the visibility and strategic engagement of working directly with a biotech leader, while maintaining CRO support and infrastructure.
      • Advance life-saving research: Be a part of cutting-edge cell and gene therapy trials, helping bring breakthrough therapies to patients faster.
      • Grow your career intentionally: Gain exposure to high-impact projects with opportunities to step up into larger roles and leadership paths.
      • Collaborate where it counts: Enjoy the flexibility of remote work with access to in-office opportunities that foster deeper team integration and mentorship.
      • Be mission-aligned: Work with a team that shares your urgency, attention to detail, and dedication to patients battling cancer and rare diseases.Why Join Us?This role offers the opportunity to do more than manage clinical trials - it's a chance to be at the center of some of the most promising therapeutic advancements in the world. You'll play a critical role in accelerating the development of treatments that could change patients' lives forever.If you're looking to grow your career while making a real-world impact, we invite you to apply and join a mission that matters.At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.Salary Range:The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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Syneos Health/ inVentiv Health Commercial LLC