Sr. Manager - Clinical Trial Lead
Biogen
6 months ago
Remote friendly (Triangle, NC)
United States
Clinical Research and Development
Responsibilities
- Independently manage and ensure delivery of one or more clinical studies.
- Partner with cross-functional representatives to develop operationally feasible, robust protocol designs applying patient focus, risk management, quality, and scientific integrity; manage budget responsibility and endpoint-driven cost considerations.
- Develop and implement study-level operational plans, cascading key operational aspects from the Integrated Asset Plan (IAP) and Program Operational Plan (POP) to support protocol delivery.
- Manage day-to-day study operations to ensure successful delivery.
- Manage study execution activities to ensure GCP compliance, track milestones, and resolve operational risks.
- As a core Study Management Team (SMT) member, use available data to support informed SMT decisions and align execution with agreed strategy and plans.
- Support development of comprehensive clinical trial budgets reflecting all trial activity costs (patient care, research procedures, administrative expenses).
What You’ll Do
- Chair the SMT to drive development of scientifically robust, operationally feasible protocol concepts/protocols.
- Collaborate with core SMT and program team members on phase/disease/therapeutic area direction aligned with IAP/POP to enable governance-approved protocol development.
- Evaluate study feasibility and support protocol development using operational expertise and scientific assessment.
- Align cross-functional perspectives to build operational plans using expertise and supporting data.
- Support day-to-day study operations with strong team building, clear communications, proactive risk identification/mitigation, and compliance with protocol, GCP, and regulatory guidelines.
- Participate in ongoing data review to mitigate patient safety, study design, data integrity, and conduct issues.
- Develop study budgets aligned to endpoint needs.
Study Delivery / Execution
- Drive effective, efficient SMT operations (culture, communication, goal setting/management, strategy oversight).
- Ensure operational aspects support patient safety, endpoint integrity, and data validity.
- Demonstrate strong understanding of study design, rationale, endpoints, and patient population.
- Review outsourced study performance and partnership metrics to ensure milestones and deliverables.
- Develop project plans (e.g., Project Management Plan, Monitoring Plan, Study Risk Management Plan) and ensure required plans (e.g., Monitoring Plan, Quality Plan) are in place.
- Lead SMT to develop robust baseline plans for governance forums.
- Manage inflection points to enable course correction.
- Collaborate with Procurement for FMV transparency; monitor budget for overspending and cost drivers.
- Maintain data accuracy, completeness, and quality in study systems (e.g., Planisware, Veeva CTMS, Beacon).
- For outsourced studies, chair SMT with the CRO SMT Lead; ensure CRO risk mitigation plans and proactive issue identification/resolution.
Process Improvement
- Champion best practices; seek innovation and efficiency.
- Identify synergies across studies/programs to enhance planning and execution.
- Improve and streamline processes supporting clinical trial outsourcing models.
- Advocate for the department and promote interaction with other teams/groups.
- Contribute SME expertise and promote a strong knowledge base.
Required Skills / Qualifications
- B.A. or B. Sc. in a scientific discipline.
- 6+ years in clinical operations management overseeing outsourced clinical trials (quality, timeline, budget), preferably with sponsor and CRO experience.
- Scientific/clinical expertise; strong project management, risk assessment, contingency planning, and communication skills.
- Working knowledge of clinical development across one or more trial phases (I–IV) and cross-functional drug development.
- Expertise in Good Clinical Practices (GCP), ICH guidelines, and regulatory requirements.
- Ability to develop and execute operational plans supporting clinical trial delivery.
- Effective CRO management skills; ability to adapt to outsourcing strategies/models.
- Working knowledge of clinical trial financial aspects (budgeting, financial management, reporting, analysis).
Benefits (as listed)
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including fitness reimbursement
- Short- and Long-Term Disability insurance
- Paid vacation (minimum 15 days) and end-of-year shutdown (Dec 26–Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours sick time per calendar year
- Paid Maternity and Parental Leave
- 401(k) with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement up to $10,000 per calendar year
- Employee Resource Groups participation
- Independently manage and ensure delivery of one or more clinical studies.
- Partner with cross-functional representatives to develop operationally feasible, robust protocol designs applying patient focus, risk management, quality, and scientific integrity; manage budget responsibility and endpoint-driven cost considerations.
- Develop and implement study-level operational plans, cascading key operational aspects from the Integrated Asset Plan (IAP) and Program Operational Plan (POP) to support protocol delivery.
- Manage day-to-day study operations to ensure successful delivery.
- Manage study execution activities to ensure GCP compliance, track milestones, and resolve operational risks.
- As a core Study Management Team (SMT) member, use available data to support informed SMT decisions and align execution with agreed strategy and plans.
- Support development of comprehensive clinical trial budgets reflecting all trial activity costs (patient care, research procedures, administrative expenses).
What You’ll Do
- Chair the SMT to drive development of scientifically robust, operationally feasible protocol concepts/protocols.
- Collaborate with core SMT and program team members on phase/disease/therapeutic area direction aligned with IAP/POP to enable governance-approved protocol development.
- Evaluate study feasibility and support protocol development using operational expertise and scientific assessment.
- Align cross-functional perspectives to build operational plans using expertise and supporting data.
- Support day-to-day study operations with strong team building, clear communications, proactive risk identification/mitigation, and compliance with protocol, GCP, and regulatory guidelines.
- Participate in ongoing data review to mitigate patient safety, study design, data integrity, and conduct issues.
- Develop study budgets aligned to endpoint needs.
Study Delivery / Execution
- Drive effective, efficient SMT operations (culture, communication, goal setting/management, strategy oversight).
- Ensure operational aspects support patient safety, endpoint integrity, and data validity.
- Demonstrate strong understanding of study design, rationale, endpoints, and patient population.
- Review outsourced study performance and partnership metrics to ensure milestones and deliverables.
- Develop project plans (e.g., Project Management Plan, Monitoring Plan, Study Risk Management Plan) and ensure required plans (e.g., Monitoring Plan, Quality Plan) are in place.
- Lead SMT to develop robust baseline plans for governance forums.
- Manage inflection points to enable course correction.
- Collaborate with Procurement for FMV transparency; monitor budget for overspending and cost drivers.
- Maintain data accuracy, completeness, and quality in study systems (e.g., Planisware, Veeva CTMS, Beacon).
- For outsourced studies, chair SMT with the CRO SMT Lead; ensure CRO risk mitigation plans and proactive issue identification/resolution.
Process Improvement
- Champion best practices; seek innovation and efficiency.
- Identify synergies across studies/programs to enhance planning and execution.
- Improve and streamline processes supporting clinical trial outsourcing models.
- Advocate for the department and promote interaction with other teams/groups.
- Contribute SME expertise and promote a strong knowledge base.
Required Skills / Qualifications
- B.A. or B. Sc. in a scientific discipline.
- 6+ years in clinical operations management overseeing outsourced clinical trials (quality, timeline, budget), preferably with sponsor and CRO experience.
- Scientific/clinical expertise; strong project management, risk assessment, contingency planning, and communication skills.
- Working knowledge of clinical development across one or more trial phases (I–IV) and cross-functional drug development.
- Expertise in Good Clinical Practices (GCP), ICH guidelines, and regulatory requirements.
- Ability to develop and execute operational plans supporting clinical trial delivery.
- Effective CRO management skills; ability to adapt to outsourcing strategies/models.
- Working knowledge of clinical trial financial aspects (budgeting, financial management, reporting, analysis).
Benefits (as listed)
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including fitness reimbursement
- Short- and Long-Term Disability insurance
- Paid vacation (minimum 15 days) and end-of-year shutdown (Dec 26–Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours sick time per calendar year
- Paid Maternity and Parental Leave
- 401(k) with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement up to $10,000 per calendar year
- Employee Resource Groups participation