The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Senior Clinical Trial Leader aligned to Mentor Worldwide, LLC, located in Irvine, CA.
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
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. Learn more about Mentor at www.mentorwwllc.com for more information.
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.Primary Location
Depuy Orthopaedics. Inc. (6029)Job Function
Clinical Trial Administration