Manager, Study Design & Execution Lead

IND - 2028 Takeda Innovations India Private Limited; Bengaluru; Hybrid; INR 2,500,000 - 4,500,000; Full time

Benefits offered by this job

Annual bonus

Hybrid work

Health care for family

Life and accident insurance

Wellness programs

Employee assistance program

Humanitarian leave

Job summary

IND - 2028 Takeda Innovations India Private Limited in Bengaluru seeks a role focused on internal evidence generation study activities. You will support study setup, routine analyses, milestone tracking, and documentation to enable study teams to focus on design and interpretation.

The role emphasizes coordination across Global Evidence Generation and partners, with responsible use of AI-enabled tools and a strong emphasis on quality and traceability.

Qualifications

• Degree in a scientific, medical, life sciences, pharmacy, public health, epidemiology, data science, health economics, or related discipline is required.
• 5+ years of related work experience with 2+ years in biopharma exposure.
• Experience in evidence generation operations, study coordination, analytics operations, or medical affairs operations is preferred.

Responsibilities

• Input study details into systems, manage data inputs and analysis workflows, and generate draft outputs for review.
• Track milestones, dependencies, deviations, and execution risks; maintain study trackers and documentation.
• Coordinate with Global Evidence Generation and cross-functional partners to resolve dependencies and improve templates.
• Adopt AI-enabled tools with proper controls to improve study setup and documentation quality.

Skills

Study operations

Data management

Documentation

Cross-functional coordination

AI-enabled tools

Quality assurance

Education

Bachelor’s degree in life sciences / pharmacy / public health / data science

Tools

Study systems

Repositories & trackers

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.
• 5+ plus 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

• 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 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 Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.

Locations

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