• Senior Clinical Project Manager

    Servier PharmaceuticalsBoston, MA 02120

    Job #1359645477

  • About Servier Pharmaceuticals:

    We're an organization, committed to modelling diversity, equity, and inclusion for the entire industry, and to maintaining an inclusive environment with equitable treatment for all. We are interested in growing our team with passionate, committed, and innovative individuals. We encourage all to apply to our open roles and are always willing to consider skills and experiences outside of what is listed in the job description.

    SUMMARY OF ROLE:

    Responsible for managing one or more clinical trials in North America, ensuring compliance with applicable regulations, Good Clinical Practice, company's Standard Operating Procedures and study protocol and in line with defined study objectives, timelines and budget.

    Specific Responsibilities

    Areas of responsibility as a project manager

    • Ensures set up, conduct and closure of clinical studies

    • Contributes to the review of international study documents (e.g. study protocol, ICF, etc.) and responsible for their local adaptation when necessary

    • Conducts feasibility, including country and centers feasibility

    • Coordinates administrative and regulatory set up

    • Manages all local budget preparation aspects for the assigned studies

    • Supervises monitoring activities including oversight of monitoring activities and project management activities performed by a CRO

    • Supervises all site activities including close follow-up of subjects' recruitment, timelines, budgets and IRB submissions

    • Responsible for managing sponsor study file at the national level

    • Prepares and conducts local investigators meetings

    • Ensures study-specific trainings of the local team: CRAs, study and finance assistants, medical reviewers and other R&D team members

    • Provides continuous oversight to the CRAs and performs accompanied field visits

    • In cooperation with the local or regional Pharmacovigilance manager, follow up on pharmacovigilance aspects including required reporting

    • Contributes to the identification of the appropriate monitoring strategy and to the development of the Monitoring Plan both for in-house and outsourced monitoring

    • Tracks the quality of the study (protocol deviations, CAPA plans escalated by local teams, participation in Data Review and Surveillance meetings) and reports important issues to the global Study Team

    • Support inspection readiness activities, and acts as subject matter expert during regulatory inspections

    • Represents the local primary point of contact for HQ departments centrally coordinating trials (e.g. Clinical Operations, Scientific and Logistics departments)

    Other duties as required or directed by the Manager or Functional Management

    • Mentor and direct junior team members including study assistance, CRA and Clinical Project Manager

    • Contributes to innovative initiatives targeted to improve/revise clinical development processes

    • Collaborates on SOP development and local guidelines

    Skills and Education:

    • Bachelor's degree at least preferred in Scientific/health care related field

    • Experience of at least 3 years as a Clinical Project Manager or similar position within a pharmaceutical company or CRO

    • Knowledgeable of current FDA and local IRBs regulatory requirements and guidelines governing clinical research

    • Ability to oversee, manage and communicate effectively with research vendors and clinical sites

    • Strong attention to detail and the ability to establish priorities schedule and meet deadlines

    • Ability to work independently and take initiatives

    • Respectfully challenges current practices, decisions or ideas to promote quality and efficiencies

    • Strong knowledge of applicable computer and project management software applications

    • Strong interpersonal skill set necessary to create and maintain external collaborator relationships

    Other Relevant Information

    • Travel up to 25% of the position time

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