International Clinical Project Manager - 25969BR - EN in Levallois-Perret at Stryker Corporation

Date Posted: 4/11/2018

Job Snapshot

Job Description

The Clinical Project Manager (CPM) is involved in the planning and execution of clinical trials while adhering to budget, resource allocation, scope and timelines
The CPM Interfaces with cross functional team (clinical, divisional, and external) and acts as Stryker liaison with site investigators and study coordinators.
The CPM is responsible for providing project leadership with guidance from the Sr. and Lead CPMs.

The Clinical Project Manager will manage multiple aspects of clinical operations for assigned clinical trials/product lines to assure the highest standards of clinical study execution with guidance from Sr./Lead CPM or Program Manager.
Activities include:

  • Manages planning and communication with cross-functional teams to ensure proper execution and conduct of the trial.

  • Serves as primary contact and resource for Lead CRA, CRO and vendor personnel. Supports selection and provides oversight and management of CROs, consultants and vendors.

  • Tracks and reports on the progress of assigned clinical trials including budget and timelines.

  • Executes a project plan including management of schedule, cost, resources and deliverables (e.g. protocol, database development, reporting).

  • Develops project plans and ensures adherence to budget and timelines

  • Works with Clinical Trial Managers, Data Management, Clinical Trial Assistant and Document Control Specialist to create and manage study related documents.

  • Works closely with data management to ensure quality of clinical trial data

  • Maintains up to date knowledge of published literature in relevant therapeutic areas including a broad awareness of neurovascular issues

  • Co-monitors with CRO’s Monitors to evaluate and ensure quality of CRO Monitoring Team. Ensures that studies are conducted in accordance with the protocol, GCP / ICH guidelines, EU regulations and department SOPs.

  • Assists in preparation of regulatory documents including Notified bodies and IRB annual updates, briefing documents, CTAs, as requested

  • Assists in the development of in-house operations SOPs, guidelines and systems

  • Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable Stryker SOPs and policies

  • Oversees data clarification process as needed in conjunction with selected CRO and insure database lock according to agreed timeline

  • Input/prepare patient informed consent forms (ICFs)

  • Triage CRO and clinical site questions to Lead CPM or Director, Clinical as appropriate

  • Prepares and manages clinical trial site budgets

  • Fully supports the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).

Job Requirements

  • Master's level degree or equivalent in health/science related field

  • 4+ years experience in all operational aspects of managing clinical trials (ideally monitoring medical device studies) in a leadership role using vendors and CROs with studies and/or contractors
  • Must have a demonstrated working knowledge of GCP, ICH guidelines, and EU regulations

  • Proficiency in resource planning and financial management (clinical trial budgeting) required.

  • Certified Clinical Research Associate (CCRA certification) preferred

  • Well organized and detail oriented, strong written and verbal communication skills in English and French

  • Multi-task and work effectively in a team or independently on assigned tasks

  • Effective process and project management skills

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