Clinical Trial Manager
$153,118–$153,118 year
HybridWatertown, Massachusetts, United States
Job Summary
Lead the execution of day-to-day operational aspects of clinical study(ies) from protocol concept through clinical study report, ensuring all deliverables meet established timelines, goals, budget, and quality standards. Collaborate with cross-functional teams and CRO partners to establish study timelines, manage budgets, and select third-party vendors. Direct the cross-functional study team, assess operational performance, and manage risks by escalating issues to leadership. Support preparation for Safety Review Committee and investigator meetings, contribute to study document development including protocols and informed consent forms, and perform clinical data cleaning. Represent Clinical Operations to internal and external stakeholders while maintaining compliance with ICH/GCP and internal SOPs. This hybrid role requires regular presence at the Watertown, MA office.
Required Qualifications
- A Bachelor's Degree in health/life sciences or related field
- Minimum of five years of progressive clinical operations experience
- Trial management across phases of development
- Experience at a pharmaceutical or biotechnology sponsor
- Serving as a primary point of contact for CROs and third-party vendors
- Demonstrated knowledge of clinical operations methodologies
- Knowledge of FDA Regulations
- Knowledge of ICH/GCP guidelines in clinical trials
- Related organizational capabilities
- Project management capabilities
- Leadership capabilities
- Ability to communicate and collaborate in an open and clear manner with varied stakeholders
- Listening effectively
- Inviting response and discussion with internal partners and external service providers
- Demonstrated effective problem-solving
- Risk management to prevent and overcome complex safety and compliance related issues during clinical study implementation
Desired Qualifications
- Experience with oncology clinical trial management
- Experience with global clinical trials
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