Study Manager (CTM/APM) - FSP

Work Schedule

Environmental Conditions

Job Description

Study Manager – This position is a fully client-embedded role, dedicated to a leading bio-pharma company.

Role Purpose:

Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness.

Key Responsibilities:

• Works in close partnership with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities.
• Works cross-functionally with internal and external partners on clinical study management activities.
• Responsible for monitoring study conduct and progress, identifying and escalating risks/issues.
• Reviews key clinical documents including Protocols and Informed Consent Forms & leads development of study plans for external and internal use in assigned studies.
• Facilitates and maintains interactions with internal and external partners, ensuring successful delivery of assigned studies.
• Vendor management and CRO oversight, primary PoC, overseeing study deliverables.
• Country oversight including recruitment progress and regulatory compliance.
• Coordination of study-related activities and communications.
• Oversight of clinical supplies and materials; budget oversight – managing change orders, expenses, tracking updates.
• Oversight to ensure inspection readiness at all times.

Education Requirements:

• University degree or equivalent, preferably in medical or biological sciences.

Role Related Experience:

• At least 3+ years of relevant pharmaceutical or scientific experience.
• Knowledge of clinical trials and drug development process.
• Fluency in English
• Strong project management, communication, and leadership skills.
• Strong knowledge of GCP and ICH guidelines & Clinical study delivery process.
• Ability to manage multiple priorities.
• Excellent analytical and problem-solving skills.
• Strong Microsoft Office skills.