Managing the execution of clinical studies and data collection
Overseeing the review, monitoring, and adherence to clinical protocols
Interacting internally and externally with members of the cross-functional study team
Supervising more junior CTMs and Associate CTMs as required
Providing oversight of clinical research studies across all functional areas of the drug development process
Providing operational and strategic input into study planning and specific documents
Coordinating and leading study team meetings
Developing the subject recruitment/retention strategy
Overseeing TMF set-up, quality review, and reconciliation of study documents
Developing training materials for the study team
Managing information proactively and sharing with key stakeholders
Assuring compliance with ICH/GCP and other regulations
Overseeing preparation of RFPs and bid templates
Collaborating with counsel to negotiate and draft research contracts
Performing study risk management and implement mitigations
Managing and coaching direct reports

Bachelor’s degree required, preferably in a scientific discipline
Minimum of 8 years of prior clinical operations experience managing clinical trials, preferably with CRO/small biotech experience; at least 5 years in a supervisory role
Experience managing early phase studies is preferred
Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, IRT and EDC systems
Excellent understanding of the drug development process
Effective verbal and written communication skills
Experience in rare disease and/or oncology is preferred

discretionary annual target bonus
stock options
ESPP
401k match
top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
winter company shutdown

Senior Clinical Trial Manager

Key skills