Clinical Study Manager

Takeda Pharmaceutical Co.; Województwo mazowieckie; Vor Ort; PLN 213.000 - 293.000; Vollzeit

Zusammenfassung

Takeda Pharmaceutical Co. is seeking an experienced Clinical Study Manager (CSM) to join the Global Clinical Development Operations team in Poland.

You will oversee operational planning, delivery and oversight of global clinical studies, collaborating with cross-functional partners to ensure high quality, on-time, and within-budget execution. The role requires leading SETs, managing timelines and budgets, and ensuring compliance with ICH-GCP, CFR and CTR regulations across global programmes.

Qualifikationen

• Bachelor's degree in Life Sciences, Health Sciences, Technology or related field, or equivalent.
• 5+ years in pharma or CRO with 3+ years in study management/oversight.
• Experience in clinical trial management support in CTAs or Lead CRA roles.
• Experience in global/international studies and early-phase or Phase II/III trials.
• Familiarity with ICH-GCP, US CFR, EU CTR and local country requirements.

Aufgaben

• Lead cross-functional Study Execution Teams for assigned studies.
• Plan, oversee and deliver trials per ICH-GCP and regulations.
• Provide operational input for protocol development and docs.
• Drive feasibility assessments and site/patient burden evaluation.
• Support country and site feasibility activities and study planning.
• Develop and implement operational risk mitigation plans.
• Manage study timelines, budgets and CRO/vendor oversight.
• Escalate risks and vendor performance issues as needed.
• Coordinate with Data Management, Statistics and Regulatory for timelines.
• Ensure studies are inspection-ready and support regulatory inspections.
• Onboard study team members and external partners.

Kenntnisse

Project management

Stakeholder management

Leadership

Communication

English fluency

Ausbildung

Bachelor's degree

Advanced degree

Jobbeschreibung

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

Locations

Warsaw, Poland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time