Manager, Study Execution and Design Lead
Takeda · Bengaluru
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 escalate 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. Amongst our benefits are:
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