Sr. Study Startup Specialist
$90,000–$115,000 year
Hybrid · Princeton, New Jersey, United States
Job Summary
Senior Study Startup Specialist leading complex, global study start-up activities across oncology clinical trials in a fast-paced biotech environment. Serves as SME for study start-up, site activation strategy, regulatory submissions, and start-up process execution; mentors junior Study Start-Up Specialists; drives timely site activation and enrollment readiness in compliance with ICH-GCP, SOPs, and local regulatory requirements; develops activation strategies to optimize timelines, mitigates risks, and escalates issues to leadership; prepares and submits regulatory documents (IND, IRB/EC submissions, FDA forms); leads contract and budget negotiations with clinical sites; sets standards and drives process improvements for SSU processes, templates, and tools; provides CRO oversight for start-up deliverables and KPI tracking; ensures eTMF is audit- and inspection-ready; stays current on evolving global regulations; communicates complex start-up issues to senior stakeholders; mentors junior staff; offers a comprehensive benefits package and competitive compensation.
Required Qualifications
- Bachelor's degree in Life Sciences, Nursing, Business, or related field
- 5-8 years of progressive experience in clinical study start-up, site activation, or regulatory submissions within biotech/pharma/CRO
- Oncology clinical trial experience required; experience with biologics, bi-specifics, ADCs, or cell therapy programs strongly preferred
- Deep working knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements for clinical trial initiation
- Proven experience mentoring and developing junior team members
- Advanced proficiency with CTMS, eTMF, and clinical trial platforms
- Strong contract and budget negotiation experience
- Exceptional organizational, project management, and risk-management skills
- Ability to thrive in fast-paced, ambiguous startup environment and pivot quickly
- Strong written and verbal communication skills; able to communicate complex issues to senior stakeholders
- Demonstrated ability to drive process improvements and set standards across SSU function
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.