NewAmsterdam Pharma Corporation
Associate Director, Clinical Trial Management
Remote - USA, USA · Director
Sponsorship not specifiedDetected 27 days ago
GCPExcelClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationMicrosoft OfficeRegulatory Affairs
About the role
- This position reports to the Executive Director, Clinical Operations.
- NewAmsterdam Pharma is an equal opportunity employer.
Responsibilities
- Support the planning, initiation, execution, and closeout of clinical trials.
- Manage, and review clinical trial documentation, including protocols, informed consent forms, study plans, and reports
- Manages clinical trial timelines, enrollment and patient retention objectives, - in support of trial execution
- Support of cross-functional teams including representatives from multiple disciplines (e.g. Regulatory Affairs, CMC, etc.)
- Review and oversight of clinical trial regulatory packages prepared by the CRO in support of submissions to regulatory authorities and ethics committees
- Support the construction and maintenance of the trial master file (TMF) with vendors and assure completeness and successful transfer from vendor to NewAmsterdam Pharma
- The Associate Director, Clinical Trial Management role supports the execution, and management of clinical trials to ensure they meet regulatory requirements, timelines, and quality standards.
- You will support cross-functional teams, liaise and oversee clinical research organizations (CROs), and ensure that trials are conducted efficiently and ethically while maintaining patient safety.
Requirements
- 5+ years Phase 1-3 global clinical trial operations experience
- Advanced knowledge of GCP, ICH and FDA regulatory requirements
- Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervision
- Proficiency with clinical trial management systems (CTMS) and other related software.
Nice to have
- Bachelor's degree in a scientific discipline, RN, or equivalent.
- Experience in cardiovascular disease strongly preferred
Compensation
- Salary and Benefits:
Benefits
- We offer a competitive base salary, annual bonus, and long-term incentives.
- In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.
Equal opportunity
- equal opportunity employer.
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