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Senior Clinical Data Manager at Cytel

, , Spain -

Full Time

Start Date

Immediate

Expiry Date

27 May, 26

Salary

0.0

Posted On

26 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Database Design, Data Validation, Compliance Oversight, Project Management, RAVE, Drug Development, Data Review Plan, Data Management Plan, Clinical Study Protocols, FDA Regulations, ICH Standards, CRF, Statistical Analysis Plans, Study Reports

Industry

Pharmaceutical Manufacturing

Description

The Senior Data Manager brings advanced understanding of the clinical data management process from study start-up through database lock, including database design and data validation as per the requirements in the clinical study protocols, data review plan, & data management plan, and oversees the compliance activities across multiple CROs as it relates to data management. The scope of this role may span multiple programs and across multiple CROs.

Responsibilities

The Senior Data Manager is responsible for overseeing the clinical data management process from study start-up through database lock, encompassing database design and data validation according to study protocols and plans. This role also involves managing compliance activities related to data management across multiple Contract Research Organizations (CROs) and potentially spanning several development programs.