Manager I, Project Mgmt - 100275 - Fremont, CA - 0300 – Fremont

The Clinical Project manager will provide project management and leadership on the planning, preparation and execution of one (or more) high quality clinical project(s). Lead the Neurovascular clinical project team members toward completion of deliverables in a timely fashion within an agreed project timeline. Internally interface with data management, biostatistics, clinical research associates, trial coordinators, field clinical monitors, business alliance leads, medical directors, functional management, and act as BSC liaison with site investigators and clinical site staff.

Duties and Responsibilities:

• Responsible and accountable for one or more clinical trial(s).
  
• Responsible for ensuring the trial is “audit ready” at all times (project team training records, central files, system validation, etc.).
  
• Leverage resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.
  
• Responsible for effective communication within the Clinical Project Team and with functional management.
  
• Provide regularly updates regarding the status and progress of the trials (Therapeutic Lead, Business Alliance, etc.)
  
• Manage the project(s) within the approved budgets and timelines.
  
• Responsible for writing of clinical project deliverables such as protocol, final study report, study manuals, study tools, operational plans, etc. within the CPP framework.
  
• Prepare investigational site lists and participate in reviewing and approving investigational sites.
  
• Direct forecasting of devices necessary for project in collaboration with supply-chain; review and approve various support system specifications.
  
• Support the coordination and attend investigator and coordinator meetings, representing the clinical project team.
  
• Provide 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 the identification of project risks and the development and implementation of the mitigations for these risks.
  
• Prepare and present the status of the clinical project(s) to the Clinical Management Board.
  
• Represent Clinical on PDP core teams (with or without a clinical trial).
  
• Provide updates to the PDP core teams about the product risk documents (CRBA, FMEA, etc.).
  
• Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits.
  
• Demonstrate thorough knowledge of and coach others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BSC SOPs and policies.
  
  Minimum Education & Experience:
  Bachelor’s-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. 5-7 years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 1-3 years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Neurovascular clinical research experience is highly preferred. International traveling required up to 20%.
  
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