Kelly is currently seeking a Clinical Operations Manager for a on-going engagement at one of our Global clients located in California. This employee will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time with no end date and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
The Clinical Operations Manager manages study conduct under the guidance of a senior level manager, ensuring that operating procedures and company policies are followed. Develops and manages timelines, resourcing and budget for assigned clinical trials. Builds cross-functional support for innovative solutions and mentors/facilitates successful study team behavior. Partners with R&D Managers and Research Scientists/Clinicians to ensure that study deliverables are met. Manages relationships externally with strategic partner monitors, CROs and study site investigators/personnel.
Own processes and information required to execute and support the clinical trial including clinical trial project plan, project timelines, resourcing, budget plans, and statements of work (15%).
Accountable for the preparation and finalization of key clinical documents which include the informed consent, case report forms, and other essential study documents (30%).
Manage study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable Regulations and Guidelines required for testing investigational and/or marketed devices (30%).
Responsible for the selection of Contract Resource Organizations (CRO) and oversight of contracts, timelines, and budgets, when applicable (10%).
Contribute to improvement of clinical trial processes, including benchmarking and leveraging across other J&J companies (10%).
Perform other related duties as assigned by management (5%).
Bachelor of Science or equivalent degree.
5+ years’ experience leading trails in Clinical Research in a medical device or pharmaceutical regulated industry.
Must have a minimum of 2 year’s experience as a clinical research associate in the past and 3+ years as clinical trial leader (current or recent)
Experience working in Surgical Ophthalmology and Cataract experience
Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP).
Strong communication, organizational and interpersonal skills.
Basic understanding of diverse areas of business (e.g., R&D, Operations, QA, laboratory, regulatory, project management, etc.).
Ability to effectively negotiate and influence peers, affiliates and Regulatory agencies (primarily IRBs/Ethics Committees) to ensure that regulatory and business needs are met.
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