Sr. Manager - Clinical Trial Lead
Biogen
6 months ago
Remote friendly (Cambridge, MA)
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 consideration.
- Develop and implement study-level operational plans by cascading key operational aspects from the Integrated Asset Plan (IAP) and Program Operational Plan (POP).
- Perform day-to-day study management to ensure successful delivery.
- Manage study execution activities: ensure GCP compliance, track milestones, resolve operational risks.
- As a core Study Management Team (SMT) member, use available data to support informed SMT decisions and align execution with strategy and plans.
- Support development of comprehensive clinical trial budgets reflecting costs across patient care, research procedures, and administrative expenses.
- Chair the SMT; drive scientifically robust, operationally feasible, clear protocol concepts/protocols.
- Collaborate with core SMT and program team members to direct phase/disease/therapeutic area for study design aligned to IAP/POP and governance approval.
- Evaluate study feasibility and support protocol development.
- Support development of cross-functional operational plans; align on team perspectives using relevant data and therapeutic knowledge.
- Support ongoing day-to-day operations, ensuring compliance with protocol, GCP, and regulatory guidelines; manage communications and proactive risk identification/mitigation.
- Participate in ongoing data review to mitigate patient safety, study design, data integrity, or conduct issues.
- Ensure successful study delivery vs. time and budget forecasts; oversee SMT culture, communication, goal management, and strategy implementation.
- Maintain understanding of study design, rationale, endpoints, and patient population.
- Review outsourced study performance and partnership metrics; ensure milestones/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 baseline plans for required governance forum information (e.g., Baseline, Study Delivery forum).
- Proactively manage inflection points and course-correct as needed.
- Collaborate with Procurement on FMV transparency; monitor budget for overspending and cost drivers.
- Maintain data accuracy/completeness/quality in study systems (e.g., Planisware, Veeva CTMS, Beacon).
- For outsourced studies: chair SMT with CRO SMT Lead; ensure CRO risk mitigation plans and proactive issue identification/resolution.
- Champion best practices; seek innovation and efficiencies; improve and streamline processes for outsourcing models.
- Seek synergies with other studies/programs; advocate for the department and promote interaction with other teams; contribute SME expertise.
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 company and CRO.
- Scientific/clinical expertise; strong project management, risk assessment, contingency planning, and communication skills.
- Knowledge of clinical development phases (I, II, III, or 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 clinical trial outsourcing strategies/models.
- Working knowledge of financial aspects of clinical trials (budgeting, financial management, reporting, analysis).
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- 15 days paid vacation plus end-of-year shutdown time off (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 consideration.
- Develop and implement study-level operational plans by cascading key operational aspects from the Integrated Asset Plan (IAP) and Program Operational Plan (POP).
- Perform day-to-day study management to ensure successful delivery.
- Manage study execution activities: ensure GCP compliance, track milestones, resolve operational risks.
- As a core Study Management Team (SMT) member, use available data to support informed SMT decisions and align execution with strategy and plans.
- Support development of comprehensive clinical trial budgets reflecting costs across patient care, research procedures, and administrative expenses.
- Chair the SMT; drive scientifically robust, operationally feasible, clear protocol concepts/protocols.
- Collaborate with core SMT and program team members to direct phase/disease/therapeutic area for study design aligned to IAP/POP and governance approval.
- Evaluate study feasibility and support protocol development.
- Support development of cross-functional operational plans; align on team perspectives using relevant data and therapeutic knowledge.
- Support ongoing day-to-day operations, ensuring compliance with protocol, GCP, and regulatory guidelines; manage communications and proactive risk identification/mitigation.
- Participate in ongoing data review to mitigate patient safety, study design, data integrity, or conduct issues.
- Ensure successful study delivery vs. time and budget forecasts; oversee SMT culture, communication, goal management, and strategy implementation.
- Maintain understanding of study design, rationale, endpoints, and patient population.
- Review outsourced study performance and partnership metrics; ensure milestones/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 baseline plans for required governance forum information (e.g., Baseline, Study Delivery forum).
- Proactively manage inflection points and course-correct as needed.
- Collaborate with Procurement on FMV transparency; monitor budget for overspending and cost drivers.
- Maintain data accuracy/completeness/quality in study systems (e.g., Planisware, Veeva CTMS, Beacon).
- For outsourced studies: chair SMT with CRO SMT Lead; ensure CRO risk mitigation plans and proactive issue identification/resolution.
- Champion best practices; seek innovation and efficiencies; improve and streamline processes for outsourcing models.
- Seek synergies with other studies/programs; advocate for the department and promote interaction with other teams; contribute SME expertise.
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 company and CRO.
- Scientific/clinical expertise; strong project management, risk assessment, contingency planning, and communication skills.
- Knowledge of clinical development phases (I, II, III, or 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 clinical trial outsourcing strategies/models.
- Working knowledge of financial aspects of clinical trials (budgeting, financial management, reporting, analysis).
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- 15 days paid vacation plus end-of-year shutdown time off (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