Clinical Project Manager
August 30, 2007 11:32 AM
My client is a respected biopharmaceutical company focused on small-molecule therapeutics for cancer and autoimmune disorders, located in Cambridge, Massachusetts.
We are seeking a Clinical Project Manager to oversee and track the progress of site identification, start-up, monitoring and study completion activities. The role will include the management of CROs and/or contract CRAs and other clinical vendors.
You will help develop clinical protocols and documentation, manage study budgets, plan timelines and ensure that deliverables are achieved and deadlines are met. You'll oversee and review CRA performance and work effectively with the rest of the clinical team.
The successful applicant will have 5-10 years of progressive experience in clinical operations, with at least 2 years of site monitoring (CRA) experience as well as trial management experience. Specific experience with clinical trials in oncology would be valuable.
You should have excellent communications and organizational skills and the ability to understand and manage the "big picture" of global registration trials (principally phases II and III). Good interpersonal and project management skills are a must, and thorough knowledge of ICH-GCP guidelines and FDA regulations pertaining to the drug development process is required. This role may require some travel (25%). Applicants should have at least a bachelor's degree in a relevant field of study; an advanced degree would be an asset.
payscale: ~$100,000 USD
job type: full-time
We are seeking a Clinical Project Manager to oversee and track the progress of site identification, start-up, monitoring and study completion activities. The role will include the management of CROs and/or contract CRAs and other clinical vendors.
You will help develop clinical protocols and documentation, manage study budgets, plan timelines and ensure that deliverables are achieved and deadlines are met. You'll oversee and review CRA performance and work effectively with the rest of the clinical team.
The successful applicant will have 5-10 years of progressive experience in clinical operations, with at least 2 years of site monitoring (CRA) experience as well as trial management experience. Specific experience with clinical trials in oncology would be valuable.
You should have excellent communications and organizational skills and the ability to understand and manage the "big picture" of global registration trials (principally phases II and III). Good interpersonal and project management skills are a must, and thorough knowledge of ICH-GCP guidelines and FDA regulations pertaining to the drug development process is required. This role may require some travel (25%). Applicants should have at least a bachelor's degree in a relevant field of study; an advanced degree would be an asset.
payscale: ~$100,000 USD
job type: full-time
This job has been filled.