Senior Study Start-Up Specialist

The Senior Study Start-Up Specialist (SSUS) produces high-quality deliverables at the country level for all clinical trial site activation activities, leveraging project requirements and applicable country rules to ensure effective outcomes. This role is essential to ensuring investigator sites are prepared to start clinical trials with emphasis on reducing site activation timelines, facilitating rapid clinical trial start up, and collating and tracking of site feasibility.

With minimal oversight from the Study Start-Up Manager, the SSUS works independently as well as collaboratively with internal cross-functional partners (e.g., Clinical Operations, Regulatory, Study Start-Up Specialists) and external stakeholders, including contract vendors, on project-specific deliverables. The SSUS ensures compliance and tracks milestone progress in agreed upon SSUS tracking system in real time, analyzing data to provide insight and rationale for forecasted timelines that are not realized and delayed. If forecasted timelines are not realized and delayed, the SSUS analyzes all relevant data to provide rationale for and insights into delays, provides contingency plans to mitigate impacts, and escalates issues as soon as identified. The SSUS ensures continuous improvement of process and quality in all Site Start-Up activities at the country level where assigned and contributes to change initiatives across the SSU department. This role may have line management and/or mentoring responsibilities for junior staff.

Essential Functions

• Independently identify and resolve minor to moderately complex site-related issues and risks during the start-up process, including risks that can impact site activation timelines. Escalate complex issues to Study Start-Up leadership and Clinical Trial management as appropriate and actively participate in their resolution.
• Manage the preparation and submission of ongoing regulatory documentation, including amendments, periodic notifications required by central and local IRB/Ethics Committee (EC) as needed within the country, and safety reports and notifications, ensuring alignment with both local and international regulatory requirements.
• Collect and maintain current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information within JVRIM/CTIS as well as similar information for other related organizations for the assigned country (e.g., IRAS).
• Ensure Confidential Disclosure Agreements are in place and clinical trial insurance is in place for submission.
• Collect and review initial regulatory packets and site contracts for investigator sites, partnering with Regulatory, Legal, Contractor Vendors, and Study Start-Up Leadership to secure required authorization of these documents. Inform team members of completion status of regulatory and contractual documents for individual sites.
• Obtain and maintain regulatory and ethics approvals, review, and approval of essential documents for IP release.
• Inform team members of completion status of regulatory and contractual documents for individual sites.
• Apply knowledge and judgment to influence continuous improvement efforts aligned with organizational goals and regulatory standards.
• Ensure all relevant documents are submitted to the Trial Master File (TMF).
• Active involvement in the creation and development of start-up plans and essential document checklists.
• Manage SSU data tracking entries, ensuring completeness and accuracy.
• Review site performance metrics and provide feedback to Study Start-Up Leader
• Active involvement with training within SSU department and updating of SOPs/WI
• Routinely participate in project meetings with cross-functional department leads, providing updates on all site activation activities.
• The listed responsibilities and essential functions are not exhaustive. The Company may assign other responsibilities as needed.

Required Knowledge, Skills, and Abilities

• Pharmaceutical or related industry experience, including regulatory and study start-up experience and experience with in-house trials/process design
• Excellent knowledge of GCP and regulations and Standard Operating Procedures
• Adept at understanding study phases and general knowledge of how they apply to clinical development
• Excellent ability to establish rapport and build relationships with internal and external stakeholders at all levels of seniority
• Excellent attention to detail and problem-solving skills
• Ability to mentor, motivate, and lead junior staff. Previous mentoring or people management experience is helpful
• Demonstrated ability to work independently as well as collaboratively within a fast-paced, dynamic environment
• Advanced knowledge of Word, Excel, and PowerPoint

Required/Preferred Education and Licenses

• Bachelor's Degree or equivalent combination of education, training, and experience.