Clinical Study Manager
Takeda · Warsaw · PLN 212,800–PLN 292,600 (stated in the posting)
Job Description
Clinical Study Manager (CSM)
Location: Poland Lodz
Function: Global Clinical Development Operations (GCDO)
Organisation: Global Development Organisation (GDO)
About the Role
We are seeking an experienced Clinical Study Manager (CSM) to join our Global Clinical Development Operations team.
As a key member of the study execution team, you will be accountable for the operational planning, delivery and oversight of clinical studies supporting global clinical development programmes. You will work collaboratively with cross-functional stakeholders and external partners to ensure studies are delivered to the highest quality standards, on schedule and within budget.
This role offers the opportunity to lead complex global clinical studies, influence operational strategy, and contribute to the development of innovative medicines that make a meaningful difference for patients worldwide.
Key Responsibilities
As a Clinical Study Manager, you will:
- Lead and participate in cross-functional Study Execution Teams (SETs) for assigned clinical studies.
- Plan, oversee and deliver clinical trials in compliance with ICH-GCP, applicable regulations and company procedures.
- Provide operational expertise and input into protocol development and study-related documentation.
- Drive operational feasibility assessments, including evaluation of patient and site burden.
- Support country and site feasibility activities and contribute therapeutic and operational expertise to study planning.
- Develop and implement operational strategies, ensuring appropriate risk identification and mitigation plans are in place.
- Manage study timelines, budgets and external spend throughout the study lifecycle.
- Oversee Contract Research Organisations (CROs), strategic partners and external vendors, ensuring effective delivery and sponsor oversight.
- Act as an escalation point for operational risks, issues and vendor performance concerns.
- Partner with Data Management, Statistics and Regulatory colleagues to ensure alignment of study delivery, database lock and reporting timelines.
- Ensure assigned studies remain inspection-ready and support regulatory inspections when required.
- Facilitate onboarding of study team members and external partners.
What You'll Bring
Essential Qualifications & Experience
- Bachelor's degree in Life Sciences, Health Sciences, Technology or a related discipline, or an equivalent combination of education, training and experience.
- 5+ years' experience in the pharmaceutical industry and/or a Clinical Research Organisation (CRO), including 3+ years of clinical study management/oversight experience.
- Significant clinical trial management support experience, such as Clinical Trial Assistant, Clinical Trial Associate or Lead CRA experience.
- Experience supporting either early-phase clinical studies or Phase II/III studies.
- Experience working on global or international clinical studies or programmes.
- Knowledge of global clinical research regulations and compliance requirements, including:
- ICH-GCP
- US CFR requirements
- EU Clinical Trial Regulation (CTR)
- Awareness of local country requirements
Preferred Qualifications
- Experience across multiple therapeutic areas.
- Advanced degree (Master's or Doctorate).
- Additional relevant training, fellowships, internships or similar development experiences.
Key Skills
- Demonstrated success in project and programme management.
- Strong matrix leadership and stakeholder management skills.
- Excellent communication and influencing capabilities.
- Strong organisational, analytical and problem-solving skills.
- Ability to manage competing priorities in a complex global environment.
- Excellent collaboration and teamwork skills.
- Fluent written and spoken English.
Why Join Us?
You'll have the opportunity to work in a highly collaborative global environment, helping to advance clinical development programmes that have the potential to transform patient outcomes. You'll partner with experts across multiple functions while developing your own leadership and study management expertise on a global scale.
Compensation Range:
zł212,800.00 - zł292,600.00