Senior Manager / Associate Director, Clinical Operations
Boston, Massachusetts, United States · Origin Biosciences
Sr. Manager/Associate Director, Global Clinical Study Manager
Clinical Development / Clinical Operations
The Sr. Manager/Associate Director will function as a cross-functional study team lead for a late stage pediatric development program, responsible for delivery of all clinical trial operational activities, across multiple studies. This role should demonstrate strong matrix management skills, confidence in working independently and have proven ability to champion a team to deliver on key study milestones. In addition, he/she will be responsible for operating within budget and in accordance with established timelines and quality standards.
Role will be filled commensurately to experience.
Responsibilities include, but are not limited to:
Study Planning and Management: Establish and coordinate all on-going study management activities, including leading the cross-functional study team to develop an overall study execution plan to deliver on key study deliverables. Daily activities may include updating/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.), monitoring study status across internal Origin functions and external vendors, anticipating and mitigating risks within the timeline, quality and cost paradigm.
Study Team Meetings: Lead team meetings, as assigned, both internally and with multiple vendors. Attend Origin Project Team and/or Executive Team Meetings, as required.
Clinical Trial Budgeting: Maintain oversight of clinical operations budget, including regular forecasting and internal reporting to Origin management and finance; review vendor invoices against scope of work and work completed to date; identify and communicate variances.
Vendor Management: Responsible for management of all clinical operations support vendor contracted for the assigned study(ies); oversee budgets and timelines, performance management, risk management and issue resolution.
eTMF Management/Maintenance: Manage and maintain electronic Trial Master Files and associated vendors; ensure eTMF is inspection-ready in collaboration with Origin QA.
Other duties as assigned
Position Requirements and Experience
- BA/BS required in a scientific/medical field. Advanced degree preferred.
- At least 7 years of experience in managing global clinical trials within the biopharma industry. Significant portion of this experience should be in late stage development studies.
- Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities.
- Significant experience with cross-functional leadership of clinical teams, including leading data review, database lock and study reporting activities. Strong vendor management experience required.
- Preferred experience in neurology clinical trials and/or rare/orphan disease studies and/or pediatric studies preferred.
- Experience in maintenance of a submission ready eTMF required.
- Certified in GCP and strong working knowledge in ICH GCP E6 R2 regulations.
- Demonstrate strong leadership and matrix management skills, ability to multi-task in a dynamic and fast paced environment.
- Excellent written and verbal skills required. Knowing of Microsoft Project preferred.