Clinical Data Management Manager

Job Role: Senior Manager Clinical Data Management

Job Location: Navi Mumbai, MH / Thane, MH

Work Mode: (Hybrid/WFO)

Skills Required:

Experience: 8-10 Years(Rel 7+ yrs)

• Senior Manager, Clinical Data Management Under the direction of the Takeda Data Management Lead, the Senior Manager Clinical Data Management is responsible for timely and high quality data management deliverables supporting the Takeda portfolio.
• They are responsible for conducting oversight of Data Management activities at the project or program level - as performed within Takeda or by Strategic Partners, CROs or other 3rd Party Vendors - to ensure they meet obligations as described in ICH-GCP and Takeda's Scope of Work, maximize effectiveness and maintain budgets.
• The Senior Manager Clinical Data Management provides and enables solutions for complex problem solving that align with the Takeda values.
• The Senior Manager Clinical Data Management serves as an expert for clinical data management.
• They will lead cross-functional team members to perform proper Data Reviews and provides guidance on CDISC standards.

Educational Qualifications

• BS/BA required preferably in a health-related, life science area or technology-related fields.

Experience

• Preferred 6 plus years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
• Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
• Experience with all phases of development in one or more therapeutic areas preferred.
• Ability to handle multiple development programs simultaneously.
• NDA/CTD Experience preferred.
• Strong knowledge of data management best practices & technologies as applied to clinical trials.
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function