Senior Clinical Trial Manager

Rocket Pharmaceuticals•Cranbury, NJ

About The Position

Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. The Sr. Clinical Trial Manager reports through the Director, Clinical Operations – AAV and will be responsible for the operational aspects of the planning, implementation, and execution of the clinical studies for our AAV programs. The Sr. CTM will drive collaboration with internal stakeholders to ensure expected timelines, quality standards, Good Clinical Practices and applicable regulations are being met throughout study development, maintenance, and close out.

Requirements

Bachelor’s degree is required, preferably in health care or life sciences or other related field of study.
10 years of relevant clinical trial experience in the pharmaceutical or biotech industry.
Minimum of 5 years managing all aspects of clinical trial activities (start-up through close-out) including vendor management, preferably in a global environment
Direct clinical monitoring and site management experience is required.
Thorough, integrated knowledge of all Clinical Operations and site management/site monitoring activities using ICH/GCP
Ability to troubleshoot site-related issues and provide solutions and mitigation strategies.
Prior experience working on cross-functional teams in a lead capacity.
History of successfully developing effective relationships with outside vendors, CROs, and central/specialty labs
Demonstrated experience with EDC (Rave), CTMS and eTMF (Veeva) platforms.
Ability to adapt and prioritize competing demands within a dynamic environment.
Outstanding organizational, time management, planning and record keeping skills.
Advanced skills in Project Management, particularly regarding management of schedule, budget, communication, resources, and quality

Nice To Haves

Experience in gene therapy, rare/orphan disease, and cardiology are highly desirable.
Experience in regulatory filings (e.g., NDA, BLA, MAA) highly desired.

Responsibilities

Lead the planning, start-up, execution, maintenance, and close-out of clinical studies to ensure delivery against timelines, budget, quality, and regulatory requirements.
Provide operational guidance and input into protocol development, study design, enrollment planning, patient recruitment and retention strategies, and study execution plans.
Oversee site feasibility, selection, activation, training, monitoring, and close-out activities while ensuring compliance with GCP, SOPs, FDA, ICH, and applicable regulatory requirements.
Serve as the primary Clinical Operations lead and key point of contact for cross-functional study teams, investigators, CROs, vendors, and clinical sites.
Manage study progress, timelines, risks, issues, and mitigation plans, providing regular updates, metrics, and study dashboards to stakeholders and leadership.
Ensure the integrity, quality, and inspection readiness of study conduct and documentation, including oversight of monitoring activities, protocol deviations, eTMF/CTMS maintenance, audits, and regulatory inspections.
Partner cross-functionally with Clinical, Regulatory, Quality, Supply Chain, Biospecimen Operations, Legal, Procurement, and external vendors to support successful study execution and delivery of study milestones and clinical documents.
Oversee CRO and vendor performance, budgets, contracts, invoices, and deliverables to ensure effective partnership and operational excellence throughout the study lifecycle.