Global Lead Clinical Study Manager – Strategy & Delivery

POL - 6999 Takeda SCE; Warszawa; Hybride; PLN 253 000 - 347 000; Plein temps

Résumé du poste

Takeda is seeking a Lead Clinical Study Manager to drive the operational strategy and execution of clinical studies across assigned programmes. You will lead cross-functional study teams and partner with internal stakeholders and vendors to ensure high-quality, compliant studies delivered on time and within budget.

You will chair the Study Execution Team, oversee CROs and partners, and provide input into study protocols.

Qualifications

• Bachelor’s degree (or equivalent) in life sciences or a related field.
• 6+ years' experience in clinical research/pharmaceutical industry; strong global study management.
• Proven ability to lead cross-functional teams in a matrix environment.
• Strong knowledge of global clinical regulations (ICH-GCP, EU CTR, US CFR).
• Excellent project management, problem-solving, and organizational skills.
• Strong communication and stakeholder management capabilities.
• Fluent English (written and spoken).

Responsabilités

• Lead the operational planning, strategy, and execution of assigned clinical studies or programmes.
• Chair and drive the Study Execution Team (SET) to deliver study objectives in line with timelines, budget, and quality standards (ICH‑GCP and Takeda SOPs).
• Oversee CROs, strategic partners, and third-party vendors for performance and compliance with Takeda standards.
• Provide operational input into study protocols and related documentation, ensuring feasibility and alignment with programme strategy.
• Lead study budget planning and oversight of external spend with Finance and Programme Leadership.
• Identify, manage, and mitigate study risks, escalating issues as appropriate.
• Support country and site feasibility and selection processes, aligning with study strategy.
• Ensure studies are inspection-ready; support regulatory inspections when required.
• Mentor and support study management team members and contribute to initiatives.

Connaissances

Cross-functional leadership

Project management

Stakeholder management

Communication

English fluency

Formation

Bachelor’s degree in life sciences or related field

Description du poste

Takeda is seeking a Lead Clinical Study Manager to drive the operational strategy and execution of clinical studies across assigned programmes. You will lead cross-functional study teams and partner with internal stakeholders and vendors to ensure high-quality, compliant studies delivered on time and within budget.

You will chair the Study Execution Team, oversee CROs and partners, and provide input into study protocols.