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Description
Project Manager II – Arden Hills, MN – Peripheral Vascular
Delivering on the promise of medical innovation begins at Boston Scientific!
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. Join a global organization that is fueled by the diversity and talent of its entire workforce.
General Summary:
Provides project management and leadership to plan, prepare and execute high quality large scale and/or complex clinical program(s). Leads the clinical project team members toward completion of deliverables in a timely fashion within an agreed project timeline. Internally interfaces with data management, biostatistics, clinical research associates, trial coordinators, field clinical monitors, business alliance leads, medical directors, functional management, and acts as BSC liaison with site investigators and clinical site staff.
Duties and Responsibilities:
- Responsible and accountable for several (possible global) clinical trials.
- Responsible for ensuring the trial is “audit ready” at all times (project team training records, central files, system validation, etc.).
- Leverages 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.
- Provides regularly updates regarding the status and progress of the trials (Therapeutic Lead, Business Alliance, etc.)
- Manages the program(s) within the approved budgets and timelines.
- Responsible for writing of clinical project deliverables such as protocols, final study report, study manuals, study tools, etc. within the CPP framework.
- Prepares investigational site lists and participates in reviewing and approving investigational sites.
- Directs forecasting of devices necessary for project in collaboration with supply-chain; reviews and approves various support system specifications (e.g. IVRS, etc.).
- Supports the coordination and attends investigator and coordinator meetings, representing the clinical project team.
- 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 the identification of project risks and the development and implementation of the mitigations for these risks.
- Prepares and presents the status of the clinical program(s) to the Clinical Management Board.
- Represents Clinical on PDP core teams (with or without a clinical trial).
- Provides 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.
- Demonstrates thorough knowledge of and coaches 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. Masters-level degree (or equivalent), or qualification in clinical trial management / medicine preferred. 8+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 3+ years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Previous experience with complex, global trials is preferred.
Working Conditions:
General office environment, approximately 30 - 50% travel to research laboratory or hospital settings, meetings and other BSC facilities. Potential exposure to blood borne pathogens and other potentially infectious materials
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