Senior Study Start-Up Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee study start-up, including initial and ongoing submissions, while adhering to established timelines and quality benchmarks.

• Ensure compliance of clinical trial activities during study start-up with ICH/GCP, BeOne SOPs, and local regulations.

• Collect and track start-up metrics in relation to KPIs.

• Promote best practices and process enhancements within the study start-up team and the Americas region.

• Lead the setup of central IRB from initiation to close-out.

• Act as the primary contact for study start-up onboarding and process enhancements in the Americas.

• Execute study start-up activities, from site identification to activation.

• Offer country-specific study start-up expertise to project teams.

• Provide support for study start-up leads as needed.

• Engage with sites during the feasibility phase, execute CDAs, and gather information to aid in site identification and selection.

• Coordinate with CRAs, FMDs, CSMs, and other internal stakeholders.

• Suggest potential initial sites to achieve First Patient In (FPI) status.

• Drive the initiation and completion of tasks from site selection through activation.

• Utilize site partnership data to minimize start-up cycle times.

• Prepare, negotiate, manage, and submit documentation from start-up to close-out.

• Prepare and present documents to the central IRB for prompt reviews.

• Facilitate discussions in study start-up forums.

• Create local workflows to enhance the efficiency of deliverables.

• Oversee resource allocations and engage in resource forecasting.

• Enhance study start-up infrastructure across the Americas.

• Interview and onboard new hires for line management and FSP roles.

• Ensure compliance with ongoing training requirements.

• Conduct regular one-on-one meetings, provide feedback, monitor goals, mentor, and develop team members.

• Perform mid-year and year-end performance check-ins and evaluations.

• Participate in meetings with FSP leadership and line managers.

⛳️ Requirements

• A Bachelor’s degree or higher in a scientific or healthcare discipline is preferred.

• At least 7+ years of progressive experience in clinical research and clinical operations, ideally within the biotech, pharmaceutical sector, or CRO setting.

• Expertise in conducting study start-up activities from site identification to activation.

• Country-specific knowledge in study start-up processes.

• Familiarity with ICH/GCP, relevant country regulations/guidelines, and SOPs.

• Understanding of clinical trial execution.

• Ability to effectively prioritize tasks.

• Excellent written and verbal communication abilities.

• Highly organized with strong attention to detail.

• Committed to diligent follow-through.

• Proficient in risk mitigation strategies.

• Experience in line management.

• Knowledge and/or experience with the Functional Service Provider model.

• Background in mentoring and training team members.

• Proficiency in Microsoft Office applications: Outlook, Word, Excel, PowerPoint, and Teams.

• Ability to manage and sustain study start-up resources.

• Willingness to travel up to 10% of the time.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Opportunity for discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account (FSA)/Health Savings Account (HSA).

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness benefits.

• Up to 10% travel required.