Job Title:  Clinical Trial Manager-Oncology (2 openings)

Assignment Duration:    1 year

Job Description: 

Position Summary:
The Clinical Trial Manager will support Oncology Clinical Operations by managing investigator-sponsored trial operations and ongoing quality improvements in the processing and review of ISTs. The CTM will liaise with field medical teams, medical strategy, legal, and other departments as needed to ensure investigator sponsored trial requirements are met or exceeded. Key responsibilities include coordination of concept submissions to cross-functional committee review teams, forecast and tracking of study budgets and milestones, ensure timely distribution of Dear Investigator Letters, oversee that study progress is tracked and reported to the cross-functional team, ensure clinical trial databases are maintained, and actively participate in process improvement initiatives, taskforces, and committees within Clinical Operations.

Role Responsibilities:
Participate in the review and critique of investigator-sponsored trial protocols for compliance with company policy and alignment with corporate strategy.
Track the execution of the ISTs and budgets from approval decisions through execution of contract payments, and outcomes.
Critically evaluate budgets for proposed ISTs.
Maintain an accurate and current database on the status of all ISTs.
Participate in cross-functional teams and ensure working teams meet frequently to evaluate IST progress and provide feedback
Provide mentoring to Clinical Trial Coordinators in study management and conduct of clinical trials, as appropriate
Demonstrate functional knowledge of Good Clinical Practices, Corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines

Must have 4 years of experience and have extensive experience in Oncology. Must have a Bachelors degree in a scientific discipline.

If interested, please email your resume at gmauk@greenkeyllc.com or call me at 407-209-3343.