The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Clinical Trial Manager 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. Qualifications
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 wil:
• Serve as a Clinical Trials Manager within the Clinical R&D Operations CoE group to execute company sponsored clinical trials for the Medical Device Franchises
• Manage all operational activities of assigned clinical trials/programs within the Clinical R&D Operations group
• Serve as a member of the clinical trial/study/program core team and may serve as the back-up liaison to the Clinical R&D Franchise and Clinical R&D BSDM for projects/trials/programs under his/her responsibility
• Serve as the primary contact for clinical trial sites
• Independently solve problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed
• Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
• Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
• Be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed
• Plan, track and manage assigned projects budgets to ensure adherence to business plans
• Support the implementation of new clinical systems/processes, and provide support for publications, as needed.
• Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
• Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
• Provide primary leadership within a clinical trial, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus.
· Ensure efficient use of resources within the clinical trial/program to provide high quality deliverables.
· Ensure that outstanding performance is rewarded and consistently strives to improve the performance, reputation, and image of the R&D Clinical CoE.
· Manage and mentor Clinical Trial Leaders/Sr. Clinical Trial Leaders/Staff Clinical Trial Leaders, as applicable.
· Be responsible for the training, performance management, and development of clinical staff.
· Account for quality, compliance with regulations and company procedures, resource requirement, timelines and budgets for assigned clinical projects, including those assigned to direct reports.
· Lead clinical trials and/or a program that may involve multiple trial managers/leaders and CROs (>500k USD annual investment).
· Act as an operational expert rotating to new projects to provide technical expertise and training in starting new studies.
· Support Senior CTM within a large or complex regulated clinical trial/program.
· Exhibit proficiency and act as a Subject Matter Expert in clinical trials involving complex design issues. Provide solutions and guidance on complex situations.
· Manage work performed by CROs.
· Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, cost-effective, and high quality execution of assigned clinical studies/programs, including those assigned to direct reports.
· Support clinical trial design and strategy.
· Review and provide feedback on protocols.
· A minimum of a Bachelor’s Degree with at least 8 years of clinical or related technical experience required.
· A minimum of 2 years’ experience leading teams; supervisory experience is required.
· A Life Science, Physical Science, Nursing, or Biological Science degree is preferred.
· Advanced project management skills with ability to handle multiple projects required.
· The ability to influence others along with strong written and oral communication skills is required.
· Knowledge of Good Clinical Practices is required.
· Experience with line management is preferred.
· Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
· Medical device experience is preferred. Primary Location
Depuy Orthopaedics. Inc. (6029)Job Function
Clinical Trial Administration