JOB TITLE: Clinical Project Manager |
DEPARTMENT/GROUP: Clinical Operations |
POSITION REPORTS TO: Director of Clinical Project Management |
SUMMARY OF POSITION: Responsible for the execution of assigned human subjects research projects (e.g., clinical trials, observational studies) by organizing and guiding the activities of cross-functional teams to ensure compliance with the protocol, SOPs, and applicable regulatory requirements, as well as allocated budget, timeline, and scope. |
ESSENTIAL DUTIES AND RESPONSIBILITIES: - Proactively manage operational aspects of assigned clinical study(ies) including management of timeline, budget, resources, and vendors
- Oversee cross-functional study team (e.g., clinical services, data management, biostatistics, pharmacovigilance, central laboratory services)
- Serve as the primary point of contact for study sponsors and lead recurring meetings
- Lead study startup efforts (e.g., trial master file setup, site selection and initiation, IRB submission, negotiation of site and vendor agreement and budgets)
- Develop and execute project plans (e.g. CMP, DMP, SMP) in accordance with study protocol, SOPs, ICH-GCP, US CFR, and other applicable regulatory requirements
- Ensure external service providers execute activities in a quality manner and per the established contract
- Ensure TMF filing, maintenance, and archival procedures are completed per SOPs
- Escalate issues and potential study risks appropriately
- Prepare for and participate in study audits and inspections
- Identify study risks and issues, and develop mitigation strategies and CAPA plans
- Create patient-facing and site-facing forms (e.g., ICFs, CRFs, ePRO)
- Prepare materials for IRB submission and ensure initial and continuing approval
- Track sites’ recruitment efforts and enrollment status of subjects
- Train research staff in procedural aspects of studies (e.g., informed consent procedures, documentation procedures)
- Assist with the coordination of data review with cross functional team to support database lock
- Prepare updates for executive team and sponsors regarding study progress
- Participate in subject recruitment and data monitoring activities as needed
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KEY QUALIFICATIONS AND REQUIREMENTS: - Bachelor’s degree in biology, clinical research, project management or related field
- Minimum three years’ experience in a clinical research environment, including a minimum of two years’ working across multiple protocols
- Fluent in English and French (additional fluency in German is a plus)
- A current resident in the EU
- Experience with development of key clinical trial documents (e.g., CRFs, ICFs, recruitment materials)
- Tech-savvy with the skills and ability to apply new systems to her/his everyday tasks
- Understand the importance of adaptability and eagerness to learn and adapt to technology changes over time
- Ability to multitask proficiently across projects
- Excellent oral and medical/technical writing skills
- Ability to communicate effectively with sponsors/clients and team members
- Strong interpersonal, leadership, and analytical skills
- Ability to lead through influence without direct authority
- Ability to demonstrate good judgement and decision making, attention to detail, and personal accountability
Job Title: Clinical Project Manager (CPM)
Department: Clinical Operations
Company: Curebase, Inc
Employment Type: Full-time, Exempt (salaried employee)
Position Location: Remote-based (anywhere in the EU) |
