Duties and responsibilities:
Responsible and accountable for the management and coordination of one or more clinical trial(s).
Responsible for trial audit readiness at all times (project team training records, central files, system validation, etc.).
Manages the project(s) within the approved budgets and timelines.
Directly in charge of the selection, contracting, coordination and management of the CROs and providers contracted for a given project.
Responsible for writing and/or supervising the CROs for the development of clinical project deliverables such as study manuals, study tools and operational plans.
Participates in writing of clinical project deliverables such as protocols, study reports and CRFs.
Prepares investigational site lists and participates in reviewing and approving investigational sites.
Prepares and presents the status of the clinical project(s) to the Clinical Management.
Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits.
Demonstrates thorough knowledge in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BALT SOPs and policies.
Reports into the Manager Clinical Operations – International (based in France)
Requirements:
Master’s degree in Life science or related field (Bac +5)
Minimum 5 years’ experience in the clinical research field
2-3 years’ experience as clinical project manager in medical devices/pharmaceutical industry, in a CRO or in an institutional promoter
Ability to develop good interpersonal relationships with medical professionals.
Excellent verbal and written communication in English and presentation skills
A second language is an asset (Spanish, German or Italian)
Must be familiar with the laws, regulations, standards, and guidance governing the conduct of clinical studies.
Ability to independently manage and provide trials status to the project team.
Excellent skills in project management and planification.
Comfortable with project management tools
Team player who is able to prioritize workload in a fast-paced environment
Independent thinker with ability to anticipate issues and risks and to mitigate accordingly
Creative thinker who can troubleshoot issues and think outside of the box to achieve Project goals
Flexibility and availability to travel in France and Europe (10%).
Location: Paris, Ile De France (remote/home based to be considered).