Manager, Study Design & Execution Lead

Posted 10 Days Ago
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Bengaluru, Bengaluru Urban, Karnataka, IND
Hybrid
Senior level
Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Takeda exists to create better health for people, brighter future for the world.
The Role
Supports internal evidence-generation study execution, including study setup, routine analysis coordination, milestone tracking, documentation, quality checks, risk escalation, and archival. Coordinates across global evidence-generation, R&D, analytics, data, local operating companies, and vendors. Maintains traceable, version-controlled, audit-ready study records and contributes to automation, AI-enabled workflows, standardization, and continuous improvement.
Summary Generated by Built In

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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 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

LocationsIND - Bengaluru

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Skills Required

  • Degree in scientific, medical, life sciences, pharmacy, public health, epidemiology, data science, health economics, or a related discipline
  • 5+ years of related work experience
  • More than 2 years of experience in the biopharmaceutical industry
  • 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 cross-functional coordination skills
  • High attention to detail and ability to manage multiple concurrent study workstreams
  • Ability to maintain complete, traceable, version-controlled study records and execution packages
  • Comfort using AI-enabled and automated tools with human review, traceability, privacy, quality, and compliance controls
  • Fluent English
  • Experience in evidence-generation operations, clinical or study operations, HEOR or real-world evidence operations, study coordination, analytics operations, or medical affairs operations
  • Experience supporting multiple concurrent study workstreams and coordinating cross-functional partners
  • Additional language proficiency

Takeda Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.

  • Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
  • Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
  • Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.

Takeda Insights

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The Company
HQ: Cambridge, MA
50,000 Employees
Year Founded: 1781

What We Do

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world.  We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts.   Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives.   Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.  

Why Work With Us

We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.

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