You have a minimum of 5 years relevant experience in clinical research and drug development with clinical operations experience (as CRA / Lead CRA or as Clinical Project Manager) and you are fluent in English (ideally in French too) ? Then this may be your dream job!"
The Clinical Project Manager will report to the Senior Clinical Research Project Manager - Team Manager
As Clinical Project Manager, you will need good organizational skills for seamless interactions with Core Study Teams, Investigators, Regulatory Department and Clinical staff.
- Initiates and manages all operational study/project activities & serves as primary point of contact for the assigned Core Project teams.
- Translates protocol/project strategies from a concept into an executable study/project.
- Focuses upon the operational integrity and feasibility of individual studies utilizing a variety of resource solutions to ensure the most effective, efficient, and high quality study/project is designed and executed.
- Participates in and influences the operational strategy for study/project delivery including milestone deliverables to optimize use of time, cost and resources.
- Participates in the identification, assessment and mitigation of risks at the study level.
- Maintains continuous communication between partner lines, strategic partners, Clinical Research Units (CRU), contractors and vendors.
- Optimize Operational Control and Effectiveness.
- Assures close partnership with study investigators to assure successful study delivery and high quality data.
- Fosters positive community attitudes and volunteer trust through professional behavior and ongoing communication.
- Responsible for assigned study/project management within the unit including study scheduling, protocol planning (start up activity) and will be the primary contact for the project teams responsible for the compound/project - from the time the study/project document is drafted until the data base/project is locked.
- Serves as primary liaison/point of contact for the assigned Core Project Teams and the Clinical Research Unit.
- Create and ensure adherence to study timelines.
- Supervises initiation and monitoring of all study activities.
- Primary point of contact for assigned study decisions related to the protocol, data collection and volunteer activities.
- Partners with different CRU departments for the planning and execution of study.
- Maintains accuracy, accessibility and confidentiality of all volunteer records and reports.
- Monitors and summarizes clinical data.
- Evaluates and may identify new equipment/technologies/vendors for improving study execution.
- Lead the data management activities for assigned protocols.
- Initiate Inform Consent Document for Ethics Comitee submission.
- Responsible for ensuring clinical trials are conducted in accordance with scientific, medical, and ethical principles, and within regulatory requirements/guidelines. Responsible for volunteer safety and accurate interpretation and execution of research protocols including multiple study activities.
- Minimum of BA/BS in a biomedical discipline or equivalent education/training is required.
- At least 5 years relevant experience in clinical research and drug development with clinical operations experience. Preferably with first experience in early drug development (Phase I and IIa).
- Substantial clinical operations and pharmaceutical industry experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues.
- Experience in Project Management and leadership of matrix teams is essential.
- Fluent in speaking and reading English. Preferably, your second language would be French or Dutch (for CRU BR).
- Drug development experience including familiarity with: Clinical study management and monitoring, Project/process management, Data management, Clinical & regulatory processes, Regulatory submissions, Budget / expense management, Experience of Vendor Management, Scientific excellence, Administrative excellence, Systems technology
- Initiating and Implementing Change: Innovation, Learning Organization, Flexibility and Resilience, Courage with Decisiveness to Act, Problem Solving, Positive approach, forward thinking, challenge the status quo.
- Matrix leadership skills: Influencing, Collaborative, supportive, Networking and Alliance Building, Personal Leadership, Team work, Communication, Negotiation, Decisive and assertive, Change agile, Able to deal with ambiguity.
- Ease in using Office tools suite (Excel, Powerpoint, Word, Outlook, etc…)
- Existing right to work in Europe
- Full-time position
- Balanced salary package based on your capabilities and experience
Vacancy number: 18897