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Clinical Project Manager (1419)
Ref No.: 18-27745
Location: Irvine, California
Clinical Project Manager
Job Description:
KellyOCG is seeking a Clinical Project Manager to support our Client, who serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing all headquartered in their talent hub in Irvine, CA.
Responsibilities
Clinical study execution in support of the Client's team and their overall Clinical Center of Excellence with a focus primarily on clinical neurovascular studies.
Fostering strong, productive relationships with colleagues within the organization
Serving as a member of the study core team and may serve as the liaison with the operating company for projects under his/her responsibility
Overall execution of small-medium regulated and non-regulated clinical projects or large non-regulated clinical projects including, but not limited to budget tracking, tracking and supporting subject recruitment, monitoring, quality of deliverables, site support and study closure
Providing support to department wide training
Quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical projects
Leading several small/medium clinical studies (regulated and non-regulated) and/or a small number of large non-regulated projects that may involve Clinical Research Associates (CRAs) and/or other clinical operations staff.
Assisting with the management of large regulated studies alongside and in support of colleague CPMs or Senior CPMs and may support CPMs and/or Senior CPMs within a large or complex clinical study.
Identifying and ensuring strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical studies under his/her responsibilities.
Managing all activities of assigned clinical studies within the Clinical R&D Operations group.
Functioning as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
Evaluating support requests for publications and to provide consolidated comments and support to the requests.
Managing Resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
Tracking assigned projects budgets to ensure adherence to business plans.
Supporting the implementation of new clinical systems/processes, and provide support for publications, as needed
Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
Providing quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies
Qualifications
A minimum of a Bachelor's Degree required: Life Science, Physical Science, Nursing, or Biological Science degree is preferred
5+ years of experience required as CRO- or Sponsor-level CRA or Clinical Project Manager
· 1+ years of Clinical Project Management experience
· Neurovascular clinical trial experience strongly preferred
· Personnel management experience strongly preferred
Medical device experience is preferred
The ability to influence others along with strong written and oral communication skills is required
Knowledge of Good Clinical Practices is required
Understanding and application of regulations and standards applied in clinical areas is required
Advanced project management skills with the ability to handle multiple projects required
Relevant industry certifications preferred (i.e., CCRA, RAC, CDE)
Position is located in Irvine, CA
Up to 25% domestic travel