HireDiversity

Jacksonville, FL, US

Clinical Research Manager-8441130115

Description

Vistakon, a member of the Johnson & Johnson Family of Companies is recruiting for a Clinical Research Manager located in Jacksonville, FL.

VISTAKONŽ, a division of Johnson & Johnson Vision Care, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, no other manufacturer has matched the aggressive expansion of our wide-ranging ACUVUEŽ family of products. Our associates around the world are committed to expanding the ACUVUEŽ brand, and fortifying our position as the worldwide leader in the contact lens industry.

The Clinical Research Manager manages the study preparation, conduct, and close out of clinical trials, and may provide support on product approval applications. This position will compile information required for the clinical trial project including project timelines, resourcing, budget management, contract negotiation and finalization, and review and management of scopes of work and change orders. The Clinical Research Manager will develop monitoring plans and compile data management plans, statistical analysis plans, and communication plans as part of the clinical trial project. In collaboration with the project team, the Clinical Research Manager will be responsible for preparing and finalizing key clinical documents which at minimum may include the clinical protocol, informed consent, case report form, and investigator's brochure. Additionally, this role will develop request for proposals for clinical sites and CROs and other vendors as required; as well as have the responsibility for creating the identification and selection process for the clinical sites and Contract Research Organizations (CRO). This role will support the development of Master Services Agreements, Clinical Research Agreements, Scopes of Work and Change Order in addition to managing and overseeing CRO delegated responsibilities. The Clinical Research Manager will oversee internal conduct of study specific activities and be responsible for reviewing and approving final study reports to ensure that clinical trials are conducted meeting all applicable Regulations and Guidelines required. The Clinical Research Manager will interface and cooperate with Research and Development, Regulatory Affairs, Medical Affairs, Professional Affairs, as well as the Clinical Investigators and CROs to ensure that regulatory requirements and company requirements are met.

The Johnson & Johnson Family of Companies has a strong commitment to diversity and welcomes applications for all individuals. EOE M/F/D/V

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Qualifications


A Bachelor's Degree in life sciences or equivalent is required; an advanced degree is strongly preferred. 8 years of experience in Clinical Research within the medical device/pharmaceutical industry is required. Previous supervisory responsibilities are required. The successful candidate must have a minimum of 2 years experience as a clinical research associate / monitor. Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required. Strategic and tactical Clinical and Business knowledge is necessary for this position. Strong communication, organizational and interpersonal skills are also required for this position. Broad based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, laboratory, regulatory, general project management, etc.) is required. Ability to effectively negotiate and influence peers, affiliates and regulatory agencies to ensure that regulatory and business needs are met is required. This role also requires the flexibility to provide innovative approaches to gain marketing approvals globally. The successful candidate must be proficient in Microsoft Project, Visio, SharePoint, and Excel. Ophthalmology and/or optometry clinical study experience is a strong asset. This position also requires experience with managing direct report(s) for a minimum of 1 year. This position is based in Jacksonville, FL and may require up to 25% travel, both domestic and international. The successful candidate must have experience managing multiple simultaneous clinical studies.

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Primary Location:North America-United States-Florida-Jacksonville
Organization: Johnson & Johnson Vision Care, Inc. (6094)
Travel:Yes, 25% of the time