Clinical Study Director Job

CLINICAL STUDY DIRECTOR needed for a CONTRACT opportunity with Yoh's client located in Cambridge, MA.

What You'll Be Doing:

- Medical reference and medical expertise for operational strategy within the CSO for study registries he/she is allocated to
- Medical consultant for projects to be proposed to the CSO
- Medical contact for interaction with physicians responsible for the project or the study at the customer level
- Support with his/her medical knowledge and background a study or a project from business negotiation with customers to final product delivery (eg study completion or project report or publication)
- Conduct the feasibility for study/project with the feasibility manager and other team members (especially Medical Advisors in CSUs)
- Prepare and/or organize and/or participate to Investigator's Meetings, Steering Committees, Data Monitoring Committee meetings (only "open" part of the DMC meetings).
- Prepare and/or approve any documents related to the study and requiring a medical expertise (extended synopsis, protocol, medical training material for study monitoring team and for investigators)
- Provide medical training to study team, CSUs (Medical Advisors, monitoring) and investigators
- Develop interaction with Medical Advisors in CSUs for the best knowledge of the study, compound protocol
- Participate to Investigators meetings
- Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts
- Participate to clinical trial team (and cluster if any) meetings
- Accountable for the medical review of data done by the clinical trial team, the case by case review of safety events reported to GPE and coding of events and drugs
- Provide appropriate medical input for patient recruitment and retention strategy
- Support the CSUs and affiliates to develop network of KOLs and experts and to select National Coordinators or members of Study Committees
- Prepare and provide key medical information to investigators and/experts in respect with communication policies (eg study results, DMC advice)

What You Need to Bring to the Table:

- Must be an MD
- Five (5) or more years of Clinical Research and/or Drug Development experience in Diabetes
- Knowledge in ICH, GCP and local regulations
- Fluent in English (writing and speaking)
- Additional Clinical Research and/or Drug Development experience in other therapeutic areas, especially Cardiovascular

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

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