Clinical Trial Operations Manager
hace 5 días
Medpace, Inc. is a leading Contract Research Organization (CRO) that provides clinical trial management services to biotech companies. We are seeking a highly experienced Clinical Trial Manager to join our team in Spain, specifically in our Madrid office. The ideal candidate will have expertise in cardiovascular, endocrine, and metabolic therapeutic areas and will be responsible for managing day-to-day operations of clinical trials.
Key Responsibilities:- Manage and provide accountability for day-to-day operations of clinical trials, ensuring compliance with ICH/GCP and all applicable laws, rules, and regulations.
- Serve as primary Sponsor contact for operational project-specific issues and study deliverables.
- Maintain in-depth knowledge of protocol, therapeutic area, and indication.
- Provide cross-functional oversight of internal project team members and deliverables, ensuring all necessary project-specific training is provided.
- Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable.
- Develop operational project plans and manage risk assessment and execution.
- Responsible for management of study vendor and site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables.
- Bachelor's degree in a health or life science-related field; advanced degree in a health or life science-related field preferred.
- Experience in Phases 1-4; Phases 2-3 preferred.
- Minimum of 2 years of Clinical Trial Management experience, CRO experience preferred.
- 5+ years of Project Manager/Clinical Trial Manager experience at a CRO required for a remote-based role.
- Management of overall project timeline and bid defense experience preferred.
- Strong leadership skills.
Medpace, Inc. is a global CRO that provides clinical trial management services to biotech companies. We are committed to delivering high-quality services and making a positive impact on the lives of patients and families affected by disease. Our company culture values people, purpose, and passion, and we offer a range of benefits and perks to our employees, including hybrid work-from-home options, competitive compensation and benefits package, and structured career paths with opportunities for professional growth.
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