Senior Clinical Project Manager, Cardiovascular Device (Contract, Home-Based) - RSS (R1122420) in Morrisville, NC at IQVIA™

Date Posted: 3/9/2020

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Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

General Summary:

Provides Firehawk US IDE study project management. Leads the clinical project team members toward completion of deliverables in a timely fashion within an agreed project timeline. Lead the CRO management, in every aspect of CRO’s SOW, like data management, biostatistics, clinical research associates, trial coordinators, field clinical monitors, and acts as Client liaison with site investigators and clinical site staff.

Duties and Responsibilities:

  • Key Responsible and accountable for Firehawk US IDE clinical trial.
  • 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.
  • Provides 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 coach others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable Client or CRO’s 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 US clinical/scientific research, medical devices/pharmaceutical clinical trials plus 5+years’ US pre-market medical devices/pharmaceutical clinical trials project experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.
  • US Drug-eluting stent IDE study experience is high preferred.
  • Previous experience with complex, global trials is preferred.

Working Conditions:

General office environment or home based, approximately 30-50% travel to research hospital settings, meetings and other Client facilities.

Competency Expectations:

  • Ability to understand strategic goals and match the business needs of the company. 
  • Ability to develop good interpersonal relationships with clinical / medical professionals. 
  • Good verbal and written communication and presentation skills. 
  • Must be familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies, special with North American’s. 
  • Ability to independently manage and provide significant tactical and leadership guidance to clinical team. Independently motivated. 
  • Demonstrated previous success managing multiple, complex, and international projects.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at to arrange for such an accommodation.

Job ID: R1122420