As the Clinical Project Manager you will provide clinical support to all projects at different stages of development this includes collaborating with key functions such as Project Management, Regulatory, and Quality to define requirements to develop clinical plans and timelines, and coordinating and executing project activities.
You will be part of a knit team and develop strong working relationships across the division and with our partners. You will work across a range of projects and will be able to develop your knowledge and experience. We are looking for someone who is highly organised and able to manage projects: someone who is proactive and driven in their style of working and who has exceptional communication and relationship building skills.
- Selection of clinical service providers: prepare RFPs, evaluate proposals, participate in negotiations and building recommendation to the CLIDE Leader.
- Support qualification of clinical service providers in collaboration with QRC.
- Contribute to the management of clinical trial-related activities subcontracted to service providers:
- Project management,
- Regulatory/ethics submissions,
- Data management,
- Statistical analysis,
- Medical writing,
- Quality Assurance (deviation management & risk management).
- Provide support to project managers (PCM) to monitor budget & solve potential contract issues.
- Interact with contractors to monitor subcontracted activities as regards timelines, quality of deliverables and compliance with Good Clinical Practices.
- Writing and review of essential clinical trial documents for submission:
- Investigational Brochure (IB),
Informed Consent Form (ICF) & patient information,
- Submission forms,
- Clinical study report.
- Review/approval of operational trial documents and plans, including:
- Electronic Case Report Form ((e)CRF)
- Data Management Plan (DMP) & Data Validation Plan (DVP)
- Trial Master File (TMF)
- Monitoring Plan
- Data exchange/transfer agreements
- Statistical Analysis Plan
- Management of Medincell accounts in clinical trial databases (Eudravigilance, EudraCT, Clinicaltrial.gov), in collaboration with Regulatory Affairs as needed.
Interpersonal and communication skills
- Support relationships and communication exchanges internally and with contractors
- Effectively prepare and lead meetings internally and with third parties in English
- Effective international collaboration
- Fluency in oral and written English
- Demonstrated ability and conceptual knowledge to produce high quality written documents and presentations, that effectively communicate in a clear, organized and concise manner to clinical and regulatory authorities, senior management and other decision-making bodies
- Minimum 5 years of relevant work experience in clinical development in a pharmaceutical and/or biotechnology company
- Ideally, you will hold a Master in Project Management of Clinical Operations or related
- Awareness of full drug development cycle and methodology, as well as regulatory compliance requirements in clinical operations
- Demonstrated project leadership, with experience from beginning to end of project cycle for several clinical projects
- Experience in international and multidisciplinary teams