Clinical Data Management Manager

Tekskills; Mumbai; Hybrid; INR 2,500,000 - 4,500,000; Full time

Job summary

Tekskills is seeking a Senior Manager for Clinical Data Management in Navi Mumbai, offering hybrid work arrangements. The role leads data management deliverables across Takeda-like portfolios, guiding CROs and vendors to meet ICH-GCP obligations and project budgets.

Strong CDISC knowledge and senior project oversight are required. The ideal candidate should have 8–10 years of data management experience in drug development, with expertise in cross-functional interfaces, NDA/CTD knowledge, and

Qualifications

• Bachelor-level degree in health/life sciences or tech fields.
• Significant experience in data management for drug development.
• Knowledge of CDISC standards and data capture processes.

Responsibilities

• Oversee data management activities at project/program level to ensure quality and timelines.
• Lead cross-functional teams, provide guidance on CDISC standards and data reviews.
• Ensure compliance with ICH-GCP, FDA/ICH regulations and project budgets.

Skills

CDM

Clinical data management

Programming

Study setup

Education

BS/BA in life sciences

Job description

Job Role: Senior Manager Clinical Data Management

Job Location: Navi Mumbai, MH / Thane, MH

Work Mode: (Hybrid/WFO)

Skills Required: Life Sciences CDM_Clinical database Programming Overview and study Setup

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

Job Description:

• 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