Study Start Up Manager - 258610

Role Highlights

• Work Schedule: Full-time, Monday – Friday standard business hours.
• Work Location: 100% onsite for the initial ~3-month onboarding and training period, with limited hybrid flexibility available post-onboarding based on performance and department needs.
• Impact: High-visibility position leading end-to-end study activation, protocol design, and cross-functional execution across complex clinical research programs.

Key Responsibilities

• Lead and coordinate study start-up workflows, ensuring milestones, timelines, and deliverables remain on track through study activation.
• Partner directly with Principal Investigators (PIs) and cross-functional teams on protocol development, substantive editing, research agreements, and IRB submissions.
• Build and configure electronic data capture tools and databases (e.g., REDCap), including data collection planning.
• Align operational, regulatory, financial, and contractual components prior to study launch.
• Collaborate cross-functionally across regulatory, legal, finance, and research operations teams to clear execution bottlenecks.

Required Qualifications

• Proven experience in clinical research study start-up or research program management.
• Demonstrated track record of managing multiple study start-up timelines and concurrent workstreams.
• Working knowledge of protocol development, IRB requirements, human subjects research regulations, study budgets, and research contracts.
• Strong written communication, organizational skills, and cross-functional project management abilities.

Preferred Qualifications

• Experience in an Academic Medical Center (AMC) or with Investigator-Initiated Research (IIR).
• Hands-on protocol writing, substantive editing, or direct experience developing study budgets with PIs.
• Technical experience building databases and developing data dictionaries in REDCap or similar EDC systems.
• Familiarity with clinical research agreements, including CTAs, CDAs, DUAs, and MTAs.