Manager, Study Design and Execution Lead

IND - 2028 Takeda Innovations India Private Limited; Bengaluru; Hybrid; INR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Hybrid work environment

Competitive benefits

Job summary

IND - 2028 Takeda Innovations India Private Limited seeks an experienced professional to support internal evidence generation studies. You will input study data, track milestones, and coordinate with Global Evidence Generation teams to ensure timely, audit-ready documentation. Fluent English is required, with additional languages a plus.

The role focuses on study setup, coordinated execution, and quality control, enabling R&D and analytics partners to advance study design and interpretation.

Qualifications

• Requires degree in scientific/medical/public health or related field.
• 5+ years of related work experience; 2+ years in biopharma preferred.
• Experience in evidence generation operations, study coordination, analytics, or medical affairs preferred.
• Fluent English; additional languages advantageous.

Responsibilities

• Input study details into systems, including data inputs, analysis workflows, assumptions logs, checkpoints, and documentation expectations.
• Execute defined study activities using approved processes and templates with support from various centers.
• Maintain study trackers, status summaries, action logs, review packages, and documentation checklists.
• Coordinate with Global Evidence Generation teams, R&D, Insights & Analytics, and vendors to resolve dependencies.
• Ensure documentation is complete, traceable, version-controlled, and audit-ready.

Skills

Fluent English

Coordination

Attention to detail

Cross-functional collaboration

Education

Life sciences or related degree

Job description

About the Role

Execute defined internal evidence generation study activities, including study setup support, routine analysis coordination, milestone tracking, quality review coordination, documentation, and study record archival.

Support consistent study execution within approved scope, enabling Global Evidence Generation study teams to focus on study design, methodology changes, strategic judgment, interpretation, and final decisions.

How you will Contribute

Internal Study Setup and Execution Support Input study details into relevant systems, including data inputs, analysis workflows, assumptions logs, required checkpoints, and documentation expectations.

Execute defined internal study activities using approved processes and templates, with support from R&D, the Real-World Data Center of Excellence, or analytics partners where needed.

Conduct routine analyses or execution tasks within agreed scope and generate draft outputs for Global Evidence Generation review.

Milestone Tracking and Documentation Track study milestones, dependencies, open questions, deviations, assumptions, limitations, and execution risks.

Maintain study trackers, status summaries, action logs, review packages, and documentation checklists.

Finalize execution packages and maintain study records, analysis outputs, assumptions logs, limitations, and review history.

Ensure documentation is complete, traceable, version-controlled, and linked to the appropriate study repository.

Quality, Escalation, and Stakeholder Coordination Perform first-pass checks for completeness, formatting, required fields, and documentation quality.

Escalate methodology changes, scope issues, interpretation questions, data issues, quality concerns, and strategic decision points to the appropriate accountable owners.

Coordinate with Global Evidence Generation, the Real-World Data Center of Excellence, R&D, Insights & Analytics, DD&T, local operating companies, and other study partners to resolve operational dependencies.

Support improvements to study execution templates, trackers, checklists, and handoff materials.

Digital, Automation, and AI-Enabled Ways of Working Use approved digital, automation, and AI-enabled capabilities responsibly to improve study setup, milestone tracking, documentation quality, workflow coordination, and identification of execution risks.

Apply appropriate human review, traceability, privacy, quality, and compliance controls when using AI-enabled or automated tools.

Identify repeatable study execution activities that may benefit from standardization or automation and contribute to continuous improvement of GCM ways of working.

Qualifications

A degree in a scientific, medical, life sciences, pharmacy, public health, epidemiology, data science, health economics, or related discipline is required. More than 5 + years of related work experience and more than 2 years of experience in the biopharmaceutical industry. Experience in evidence generation operations, clinical or study operations, HEOR or real-world evidence operations, study coordination, analytics operations, or medical affairs operations is preferred. Experience supporting multiple concurrent study workstreams, maintaining study documentation, and coordinating across cross-functional partners is preferred. Working knowledge of the evidence generation study lifecycle, study execution support, milestone tracking, and documentation requirements. Ability to execute defined study tasks within approved scope and elevate methodology or interpretation questions appropriately. Familiarity with study systems, repositories, trackers, study reports, analysis workflows, and audit-ready documentation. Strong coordination skills across Global Evidence Generation study teams, the Real-World Data Center of Excellence, R&D, Insights & Analytics, DD&T, local operating companies, and vendors. High attention to detail and demonstrated ability to manage multiple concurrent study workstreams. Ability to maintain complete, traceable, version-controlled study records and execution packages. Comfort using approved AI-enabled and automated tools with appropriate human review, traceability, privacy, quality, and compliance controls. Fluent English is required; additional languages are advantageous.

Benefits

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career.

• Competitive Salary + Performance
• Annual Bonus
• Flexible work environment, including hybrid working
• Comprehensive Healthcare Insurance Plans for self, spouse, and children
• Group Term Life Insurance and Group Accident Insurance programs
• Health & Wellness programs including annual health screening, weekly health sessions for employees.
• Employee Assistance Program
• 5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves
• Broad Variety of learning platforms
• Diversity, Equity, and Inclusion Programs
• No Meeting Days
• Reimbursements – Home Internet & Mobile Phone
• Employee Referral Program
• Leaves – Paternity Leave (4 Weeks) ,
• Maternity Leave (up to 26 weeks),
• Bereavement Leave (5 days)

About ICC in Takeda

Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day. As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.

Locations

Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time

Locations IND - Bengaluru - Research and Development Worker Type Employee Worker Sub-Type Regular Time Type Full time

Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time

Takeda is an equal opportunity employer.