Senior Manager, Clinical Operations
Nuvalent, Inc.
1 month ago
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities:
- Contribute to one or more clinical studies; collaborate with cross-functional clinical study teams to support delivery.
- Evaluate and ensure appropriate oversight of CROs and external vendors.
- Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals.
- Establish and maintain effective communication/collaboration with functional peers to meet study objectives.
- Identify risks and propose solutions to facilitate clinical studies.
- Review and oversee study-level budgets; manage contract/work order changes; support budget forecasting and accruals with Finance.
- Oversee and manage creation, maintenance, QC, and closeout of TMF activities.
- Ensure oversight of enrollment, site activation, and data collection milestones.
- Support completeness of study documents (protocol, investigator brochure, informed consent forms, clinical study reports, case report forms).
- Collaborate with Data Management to ensure timely database lock; participate in data review and reconciliation.
- Lead or co-lead department initiatives.
- Travel may be required (10%–15%).
Competencies:
- Detail- and process-oriented; strong project management including risk assessment and contingency planning.
- Excellent problem-solving, communication, and organization.
- Flexibility with changing priorities; critical thinking; strong attention to detail; works well under pressure.
- Collaborative; builds effective relationships across the organization.
- Demonstrated leadership; strategic planning and ability to manage multiple projects simultaneously.
Qualifications:
- 5–7+ years of Clinical Operations experience.
- Bachelor’s degree or higher in a scientific/healthcare discipline preferred; relevant biotech/pharma/CRO experience.
- Extensive knowledge of current ICH-GCP guidelines.
- Experience managing early through late Phase clinical trials.
- Demonstrated cross-functional leadership and ability to motivate teams.
- Ability to challenge status quo using a risk management approach.
- Ability to thrive in a remote/virtual environment.
Benefits:
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement savings plan, and generous paid time off (including summer and winter company shutdown).
Application instructions:
- Apply and complete the job application process; interviews may include 1:1 and/or group interviews via phone, video, and/or in-person.
- Contribute to one or more clinical studies; collaborate with cross-functional clinical study teams to support delivery.
- Evaluate and ensure appropriate oversight of CROs and external vendors.
- Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals.
- Establish and maintain effective communication/collaboration with functional peers to meet study objectives.
- Identify risks and propose solutions to facilitate clinical studies.
- Review and oversee study-level budgets; manage contract/work order changes; support budget forecasting and accruals with Finance.
- Oversee and manage creation, maintenance, QC, and closeout of TMF activities.
- Ensure oversight of enrollment, site activation, and data collection milestones.
- Support completeness of study documents (protocol, investigator brochure, informed consent forms, clinical study reports, case report forms).
- Collaborate with Data Management to ensure timely database lock; participate in data review and reconciliation.
- Lead or co-lead department initiatives.
- Travel may be required (10%–15%).
Competencies:
- Detail- and process-oriented; strong project management including risk assessment and contingency planning.
- Excellent problem-solving, communication, and organization.
- Flexibility with changing priorities; critical thinking; strong attention to detail; works well under pressure.
- Collaborative; builds effective relationships across the organization.
- Demonstrated leadership; strategic planning and ability to manage multiple projects simultaneously.
Qualifications:
- 5–7+ years of Clinical Operations experience.
- Bachelor’s degree or higher in a scientific/healthcare discipline preferred; relevant biotech/pharma/CRO experience.
- Extensive knowledge of current ICH-GCP guidelines.
- Experience managing early through late Phase clinical trials.
- Demonstrated cross-functional leadership and ability to motivate teams.
- Ability to challenge status quo using a risk management approach.
- Ability to thrive in a remote/virtual environment.
Benefits:
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement savings plan, and generous paid time off (including summer and winter company shutdown).
Application instructions:
- Apply and complete the job application process; interviews may include 1:1 and/or group interviews via phone, video, and/or in-person.