Clinical Data Management Manager

Tekskills; Thane; Hybrid; INR 2,500,000 - 4,200,000; Full time

Job summary

Tekskills in Navi Mumbai, MH is seeking a Senior Manager, Clinical Data Management to drive timely, high‑quality data deliverables for clinical studies. You will collaborate with cross‑functional teams, oversee CROs and vendors, and ensure compliance with ICH‑GCP and internal SOPs in a hybrid/WFO setup.

Ideal candidates have 8–10 years in data management or drug development, strong project management, and expertise in CDISC standards, FDA/ICH regulations, and study setup.

Qualifications

• BS/BA required, preferably in health sciences or related field.
• 6+ years in data management or drug development with cross-functional interfaces.
• Proven project management skills for data management on large programs.
• Strong knowledge of CDISC standards, FDA/ICH regulations, and data review processes.

Responsibilities

• Oversee data management activities at the project/program level to meet ICH-GCP obligations described in the scope of work.
• Provide and enable solutions for complex problems that align with company values.
• Lead cross-functional team members to perform data reviews and guide CDISC standards.
• Serve as an expert for clinical data management and ensure data quality across studies.

Skills

Life Sciences

CDM

Clinical programming

Study setup

Education

BS/BA in health 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