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Job DescriptionObjective / Purpose:- As an experienced professional, you will work independently under general direction, using your expertise to solve complex problems related to clinical study start up.
- You will analyze diverse data and apply established methods, processes, and policies to determine appropriate solutions.
- As part of the role, you will also support and manage the day-to-day work of colleagues, including those working within an FSP model, through direction, guidance, knowledge sharing, and training.
Accountabilities:
- Establish, develop and deliver the Site Start Up Plan.
- Lead the Site Start Up team to implement the plan and drive delivery of Takeda and CRO-supported sites to Ready to Enroll status.
- Partner with Clinical Operations teams and TAU partners to improve site start up metrics, processes and overall study initiation performance.
- Provide guidance and oversight to the Site Start Up team across Clinical Programs, including protocol study start up, country and site selection, planning and modeling.
- Oversee the collection and analysis of clinical trial data to drive accurate, data-driven study start up forecasts, benchmarking, and scenario planning.
- Leverage industry tools and data sources to evaluate start up timelines, data quality and cycle times, supporting project teams with site initiation forecasting and decision-making.
- Ensure consistent standards are applied across project portfolios and contribute to continuous improvement of Site Start Up processes, methodologies and technologies.
- Develop site start up strategies aligned with therapeutic area needs.
- Agree site-level deliverables with the Site Start Up team, monitor performance and proactively address potential delays or non-performance.
- Resolve escalated site start up issues in partnership with the Study Manager.
- As part of the role, provide ongoing management, guidance and operational support to FSP colleagues, helping them navigate site start up activities, resolve operational issues and deliver against agreed expectations.
- Ensure site start up activities comply with Good Clinical Practice (GCP) and applicable regulatory requirements.
Experience & Competencies:
- 4 or more years of experience in Clinical Operations, Project Management, site start up and/or trial optimization, with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor.
- At least 2 years of direct responsibility in site activation and managing site start up processes for clinical research studies at a sponsor or CRO.
- Expertise in principles driving country/site start up and study start up strategies.
- Understanding and application of Good Clinical Practice (GCP) and relevant clinical trial requirements.
- Proficiency with software models and database structures.
- Ability to interpret and explain data and facilitate data-driven decision-making.
- Ability to manage complex activities with a high level of attention to detail.
- Ability to work independently and collaborate effectively with internal and external stakeholders.
- Ability to identify and resolve complex site start up issues and escalate risks where appropriate.
- Exposure to formal or informal people management, including providing direction, guidance and support to team members.
- Demonstrated ownership and accountability, with a proactive approach to driving activities through completion.
- Motivation to make an impact by improving ways of working and contributing to better study start up performance.
- European Site Start Up experience preferred.
LocationsWarsaw, PolandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Skills Required
- At least 4 years of experience in Clinical Operations, Project Management, site start-up, and/or trial optimization
- At least 2 years of direct responsibility for site activation and site start-up processes in clinical research studies at a sponsor or CRO
- Expertise in country, site, and study start-up strategies
- Understanding and application of Good Clinical Practice and relevant clinical trial requirements
- Proficiency with software models and database structures
- Ability to interpret and explain data and facilitate data-driven decision-making
- Ability to manage complex activities with strong attention to detail
- Ability to work independently and collaborate with internal and external stakeholders
- Ability to identify and resolve complex site start-up issues and escalate risks appropriately
- Experience providing direction, guidance, and support to team members
- Demonstrated ownership, accountability, and proactive execution
- Motivation to improve ways of working and study start-up performance
- European site start-up experience
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.
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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.
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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.
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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
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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