The Cardiovascular and Specialty Solutions (CSS) group, within the Johnson & Johnson's Family of Companies, is recruiting for a Senior Clinical Trial Leader located in Irvine, CA.
Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics.
The CSS Group 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 our talent hub in Irvine, CA
The Senior Clinical Trial Leader will or may be responsible for:
- Clinical study execution within the Cardiovascular & Specialty Solutions group and the overall Clinical Center of Excellence.
- 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, study planning, initiation, budget tracking, tracking and supporting subject recruitment, monitoring, quality of deliverables, site support and study closure.
- Providing support to department wide training.
- Ensuring that all Human Resource related activities and decisions embody the Johnson & Johnson Credo Values.
- 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 under supervision of CPM or Senior CPM and May support CPM and/or Senior CPM 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.
- A minimum of a Bachelor’s Degree with at least 4 years of clinical or related technical experience required.
- A Life Science, Physical Science, Nursing, or Biological Science degree 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.
- Medical device experience is preferred.
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
- This position is located in Irvine, CA and may require up to 25% travel.
Mentor Worldwide LLC (6177)Job Function
Clinical Research non-MD
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