Study Manager (CTMAPM) FSP
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
Required Experience:
Manager
Key Skills
- Restaurant Experience
- Customer Service
- Employee Evaluation
- Management Experience
- Math
- Employment & Labor Law
- Sanitation
- Leadership Experience
- P&L Management
- Mentoring
- Supervising Experience
- Restaurant Management
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
