Senior Clinical Project Manager (Biopharma)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Senior Clinical Project Manager (Biopharma): Coordinating the operational management of clinical trials to develop compounds in line with medical and scientific standards with an accent on budget management, CRO oversight, and regulatory compliance. Focus on ensuring adherence to timelines, managing clinical study risks, and collaborating with cross-functional teams to deliver high-quality clinical study results.
Location: Hybrid role based in Cary, NC
Company
is an international research-focused biopharmaceutical group dedicated to developing innovative drugs and promoting a healthier world.
What you will do
- Coordinate operational management for 1-3 assigned clinical trials.
- Act as the primary contact for Clinical CROs and internal stakeholders.
- Ensure adherence to scope of work, timelines, and study budgets.
- Review study-related documents including project plans, monitoring plans, and risk management plans.
- Manage clinical trial supplies and study eTMF in collaboration with relevant teams.
- Prepare and review Clinical Study Reports (CSR) in cooperation with medical writers.
Requirements
- At least 3 years of experience in a similar position in a pharmaceutical company.
- Degree in Life Sciences or equivalent.
- Track record of successful planning and execution of at least 5 clinical studies.
- Fluent in English.
- Knowledge of ICH/GCP, clinical study design, and research statistics.
- Ability to work in a hybrid environment based in Cary, NC.
Culture & Benefits
- Comprehensive healthcare programs and work-life balance initiatives.
- Access to professional development resources and training.
- Competitive salary package including performance bonuses.
- Flexible working arrangements and remote work options.
- Supportive environment within a certified B Corp organization.
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