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  5. Project Manager I - Cell & Gene Therapy
Syneos Health Commercial Solutions logo

Project Manager I - Cell & Gene Therapy

Not Disclosed•Full-TimeHybrid

location_onBurton School, 3420, Cass Avenue, Chinatown, Midtown, Detroit, Wayne County, Michigan, 48201, United States

Apply Now

About Syneos Health

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. Over the past five 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.

Our Clinical Solutions team members act with a drug development mindset, applying years of experience and deep expertise to truly understand customer needs. 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.

We are passionate about developing our people through career development, supportive line management, and technical training. Central to our culture 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 committed to building an inclusive culture where you can authentically be yourself, bringing together smart colleagues from across the world to shape the future of healthcare.

About the Role

We 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 unique 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: direct sponsor collaboration and robust CRO resources.

This position focuses on early-phase trial execution, operational oversight, and cross-functional coordination across global study teams. You will be at the center of some of the most promising therapeutic advancements in the world, playing 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, you will have the opportunity to step up into larger roles and leadership paths while working with a team that shares your urgency and dedication to patients battling cancer and rare diseases.

While remote work is supported, we strongly prefer candidates located near our sponsor's Los Angeles office (near the Westwood neighborhood/UCLA campus). This location preference allows for periodic in-office collaboration and faster integration with the sponsor team, fostering deeper team connections and mentorship.

Hiring Process

To join our mission, please submit your application highlighting your experience in clinical trial execution and your passion for cell and gene therapy. We look for candidates who are ready to challenge the status quo in a highly competitive and ever-changing environment.

Equal Opportunity & Culture

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We are 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. We consider qualified applicants regardless of background and are committed to building an inclusive culture where you can authentically be yourself.

Work location

Work model: Hybrid

location_on

Burton School, 3420, Cass Avenue, Chinatown, Midtown, Detroit, Wayne County, Michigan, 48201, United States

Detroit, Michigan

Key Responsibilities

  • check_circleAct as sponsor-facing project manager ensuring successful execution of CAR-T and gene therapy trials from startup through closeout
  • check_circleCoordinate with cross-functional stakeholders to ensure timelines, budgets, and milestones are met for complex studies
  • check_circleTrack and manage protocol compliance, CAPAs, and site-level quality indicators while supporting audit resolution
  • check_circleEnsure inspection readiness by overseeing TMF maintenance, data accuracy, and documentation completeness
  • check_circleManage tracking of low-stability endpoint samples and IP-related processes to ensure timely lab delivery and site support
  • check_circleAssist with risk identification and mitigation planning while continuously optimizing trial execution processes
  • check_circleLead or support study start-up, site activation, and enrollment while collaborating with site monitors and regulatory teams

Requirements

  • verified2-4 years of clinical trial experience
  • verifiedBachelor's degree in Life Sciences, Nursing, Pharmacy, or equivalent
  • verifiedFamiliarity with GCP/ICH guidelines and FDA/EMA regulations
  • verifiedProficiency in CTMS, EDC, eTMF, and project management tools

Nice to Have

Experience in a CRO setting, prior involvement in CAR-T or other cell therapy studies, and experience working in sponsor-dedicated or embedded roles within a CRO.

Benefits & Perks

check_circleCompany car or car allowancecheck_circleMedical, Dental, and Vision health benefitscheck_circle401(k) with company matchcheck_circleEmployee Stock Purchase Plan eligibilityEligibility for commissions and performance-based bonuses
Syneos Health Commercial Solutions cover image
Syneos Health Commercial Solutions logo
Company

Syneos Health Commercial Solutions

Industry

Biotechnology Research

Headquarters

Morrisville, NC

Syneos Health Commercial Solutions operates within the biotechnology research sector, delivering fully integrated biopharmaceutical solutions from its headquarters in Morrisville, North Carolina. The organization focuses on accelerating client success by translating distinct insights from clinical, medical affairs, and commercial domains into actionable outcomes. This approach allows the company to address modern market realities while supporting the diverse needs of its customer base. By combining strategic data with operational expertise, Syneos Health Commercial Solutions facilitates the advancement of biopharmaceutical projects. For additional details regarding services and corporate information, the company directs inquiries to syneoshealth.com.
View company profile

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Skills, education and keywords

Skills: GCP, Ich Guidelines, Fda Regulations, Ema Regulations, CTMS, Edc, Etmf, Oncology, Cell Therapy, Gene Therapy.

Education: Bachelor's degree in Life Sciences, Nursing, Pharmacy, or equivalent work experience.

Frequently asked questions about Project Manager I - Cell & Gene Therapy at Syneos Health Commercial Solutions

What does a Project Manager I - Cell & Gene Therapy at Syneos Health Commercial Solutions do?expand_more
A Project Manager I - Cell & Gene Therapy at Syneos Health Commercial Solutions is responsible for the following: Act as sponsor-facing project manager ensuring successful execution of CAR-T and gene therapy trials from startup through closeout; Coordinate with cross-functional stakeholders to ensure timelines, budgets, and milestones are met for complex studies; Track and manage protocol compliance, CAPAs, and site-level quality indicators while supporting audit resolution; and Ensure inspection readiness by overseeing TMF maintenance, data accuracy, and documentation completeness.
What are the requirements for this Project Manager I - Cell & Gene Therapy role?expand_more
To qualify for the Project Manager I - Cell & Gene Therapy at Syneos Health Commercial Solutions position, applicants should have: 2-4 years of clinical trial experience; Bachelor's degree in Life Sciences, Nursing, Pharmacy, or equivalent; Familiarity with GCP/ICH guidelines and FDA/EMA regulations; and Proficiency in CTMS, EDC, eTMF, and project management tools.
Where is the Project Manager I - Cell & Gene Therapy role at Syneos Health Commercial Solutions located?expand_more
Project Manager I - Cell & Gene Therapy at Syneos Health Commercial Solutions is based in Burton School, 3420, Cass Avenue, Chinatown, Midtown, Detroit, Wayne County, Michigan, 48201, United States. This is a hybrid role.
Is this Project Manager I - Cell & Gene Therapy job remote, hybrid, or on-site?expand_more
Syneos Health Commercial Solutions has listed this Project Manager I - Cell & Gene Therapy role as hybrid.
How much experience is required for this Project Manager I - Cell & Gene Therapy role?expand_more
Project Manager I - Cell & Gene Therapy at Syneos Health Commercial Solutions typically requires 2–4 years of relevant experience at the mid level level.
What skills do you need for the Project Manager I - Cell & Gene Therapy role at Syneos Health Commercial Solutions?expand_more
Key skills for Project Manager I - Cell & Gene Therapy at Syneos Health Commercial Solutions include GCP; Ich Guidelines; Fda Regulations; Ema Regulations; CTMS; Edc; Etmf; and Oncology.
What education is required for Project Manager I - Cell & Gene Therapy at Syneos Health Commercial Solutions?expand_more
Educational requirements for this role: Bachelor's degree in Life Sciences, Nursing, Pharmacy, or equivalent work experience.
What category does the Project Manager I - Cell & Gene Therapy role belong to?expand_more
Project Manager I - Cell & Gene Therapy at Syneos Health Commercial Solutions is part of the scientific & qa job category on Recrutus.

About Syneos Health Commercial Solutions

Syneos Health Commercial Solutions operates within the biotechnology research sector, delivering fully integrated biopharmaceutical solutions from its headquarters in Morrisville, North Carolina. The organization focuses on accelerating client success by translating distinct insights from clinical, medical affairs, and commercial domains into actionable outcomes. This approach allows the company to address modern market realities while supporting the diverse needs of its customer base. By combining strategic data with operational expertise, Syneos Health Commercial Solutions facilitates the advancement of biopharmaceutical projects. For additional details regarding services and corporate information, the company directs inquiries to syneoshealth.com.

Browse more roles: All Syneos Health Commercial Solutions jobs, scientific & qa jobs on Recrutus.

Recrutus

Curating the world's most innovative career opportunities. We bridge the gap between visionary talent and industry-leading companies.

Search roles by city, category, skill, or job type — explore verified US employers, salary benchmarks, and remote-friendly teams hiring nationwide.

publiclanguageshare
Job seekers
Browse jobsCompanies hiringRemote jobsJobs by locationJobs by cityJobs by categoryJobs by skillCareer guidesCareer blogSalary insights
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CDL-A jobsExcel jobsEnglish jobsMicrosoft Office jobs
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Recrutus helps candidates discover roles that match their skills and helps teams reach qualified applicants faster. Browse by metro, discipline, or work style — from internships to senior leadership.

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Serve as key point of contact across internal and sponsor teams to facilitate communications and governance updates
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check_circleFlexible paid time off and sick time
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Quick Overview

Experience

2-4 yrs (Mid Level)

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or equivalent work experience

Job Type

Full-Time

Skills Required

GCPIch GuidelinesFda RegulationsEma RegulationsCTMSEdcEtmfOncologyCell TherapyGene Therapy
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