Senior Study Start-Up Manager

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

📋 Description

• Responsible for the timely delivery of study start-up, initial and ongoing submissions while adhering to established quality standards.

• Ensure that SSU clinical trial activities comply with specified timelines and quality benchmarks.

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

• Promote best practices and process enhancements within the SSU Team and the Americas region.

• Oversee the entire central IRB setup process up to close-out.

• Act as the primary contact for SSU onboarding and process enhancements in the Americas.

• Execute SSU activities from site identification to activation.

• Offer country-specific SSU expertise to project teams.

• Provide backup support for SSU Leads on studies as required.

• Ensure prompt follow-up, issue resolution, and updates on reports.

• Manage SSU resources, including the SSU Toolbox.

• Engage with sites during feasibility assessments, execute CDAs, and gather information for site identification and selection.

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

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

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

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

• Prepare, negotiate, and oversee documents and submissions from start-up to close-out.

• Prepare and submit documents to the central IRB.

• Facilitate discussions during SSU Forums.

• Assist in the development of local workflows.

• Manage resource allocations and participate in resource forecasting.

• Enhance SSU infrastructure across the Americas.

• Conduct interviews and onboard BeOne hires.

• Ensure compliance with training requirements.

• Conduct one-on-ones, provide constructive feedback, track goals, and foster team development.

• Carry out mid-year and year-end performance evaluations and reviews.

• Onboard FSP new hires, offering guidance, mentoring, and development.

• Attend meetings with FSP leadership and line managers.

⛳️ Requirements

• 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.

• Experience ideally within the biotech, pharmaceutical sector, or CRO environment.

• Understanding of clinical trial execution.

• Knowledge of ICH/GCP guidelines.

• Familiarity with relevant country regulations, guidelines, and SOPs.

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

• Strong ability to prioritize tasks effectively.

• Excellent written and verbal communication skills.

• Highly organized and diligent in follow-through.

• Possess risk mitigation skills.

• Experience in line management.

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

• Experience in mentoring and training team members.

• Willingness to travel up to 10%.

🏝️ Benefits

• Eligibility for an annual bonus plan for Non-Commercial roles.

• Discretionary equity awards.

• Option to voluntarily participate in the Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance.

• 401(k) retirement plan.

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

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness benefits.

• Commitment to being an equal opportunity employer.

• Provision of reasonable accommodation in the job application process.