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 Job #02866 Email this job to a friend
About our client
Our client is a young venture-backed pharmaceutical company headquartered in Massachusetts that is focused on the development and commercialization of therapeutics for blood disorders.
Position Location
Clinical Trial Manager/Senior Clinical Research Associate (Home-Based) West Coast, USA
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Prepare/review CRO proposal/contract and scope of work
2) Supervise site CDA, CTA or contract process
3) Arrange CRO training
4) Oversee CRO clinical and drug manufacturing (DM) operations as well as work on assignments
5) Monitor study and deliverable timelines as well as quality and budget
6) Act as the main contact for day-to-day CRO interactions
7) Organize hosting and development of sponsor meetings
8) Oversee site feasibility and selection process
9) Interface with CRO project managers
10) Review/approve study plans and reports
11) Accompany CRA on select site visits
12) Coordinate other study start-up activities with internal team members
13) Oversee protocol, ICF and CRF/eCRF review inputs
14) Ensure proper management and archiving of clinical trial documents
15) Coordinate DMC data review with sites, CRO and company team members
16) Attend internal and CRO teleconferences
Requirements
1) B. Sc.
2) 5 – 7 years of clinical research experience
3) 3 – 5 years of clinical trial management experience
4) Good organizational and time-management skills
5) Knowledge of computers
6) Excellent communication skills (oral and written)
7) Accessibility to a major airport
8) Willingness to travel (40% – 60%)

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