The CPM is responsible for orchestrating clinical operational activities in support of one or more clinical studies. Clinical studies are performed on a global scale in coordination with international Clinical Research Organizations. These studies will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
- Ensure the execution of clinical study activities, from study start-up through close-out, are conducted with upmost quality and in accordance with study timeline and objectives
- Provide management with routine updates regarding the status of ongoing studies
- Ensure the consistency of operational activities across studies and indications
- Review the clinical study protocol and supporting documents– Statistical Analysis Plan, CRFs, Data Management Plan, Clinical Study Report, monitoring plan, communication plan, timeline, etc. to ensure seamless integration between clinical objectives and study performance
- In collaboration with the study team, develop and implement subject recruitment strategies, and ensure enrollment remains on track
- Manage the vendor evaluation, selection, and contract process for outsourced activities
- Develop and implement vendor oversight plans for outsourced activities; ensure documentation of oversight is appropriate
- In collaboration with the Clinical Research Organization (CRO), ensure clinical monitoring resourcing needs and issue resolution are adequate for the study
- Review vendor-generated documents for accuracy, quality and consistency
- Develop and maintain relationships with internal and external stakeholders, including investigators and vendors
- Collaborate with consultants and contractors on clinical study activities
- Contribute to the development and implementation of standard operating procedures (SOPs) and common work practices
- Complete other study and/or clinical operations activities, as needed
- BA/BS with at least 5+ years of experience in clinical research operations.
- Experience in one or more clinical studies (Phase 2 and/or 3)
- Experience in study management/monitoring, as well as working and negotiating with CROs.
- Experience in project management, including the leadership and development of cross functional teams.