Clinical Research Manager Medtronic CardioVascular -
Santa Rosa, CA
Position Description
Responsible for overseeing all clinical activities related to one or more clinical studies and performing/managing the daily in-house operations associated with the studies. This position should be able to independently handle various clinical study assignments. Has supervisory responsibility for Principal Clinical Research Associates, Sr Clinical Research Associates, Clinical Research Assistants, and/or Project Coordinators as required.
Position Responsibilities
Responsible for conducting clinical programs consistent with applicable regulations, guidelines, and policies. Research, prepare, and revise the Investigational Plan (study protocol, Instructions For Use (IFU), report of prior Investigations, bibliography, Case Report Forms (CRFs), etc.) and other appropriate sections of the Investigational Device Exemption (IDE) in consultation with the cross-functional project team, investigators, data management, and biostatistics. Provides management review and approval of relevant clinical documents. Supervise training of investigators, site staff, and Medtronic clinical staff. Supervise site initiation activities. Oversee set-up and maintenance of accurate study status and implant logs. Interfaces with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, and European Clinical Groups) to drive clinical wide or cross-departmental initiatives. Develop and manage cost center budget and study budgets. Ensures appropriate resources and priorities are maintained for the various projects assigned to their area. Oversees Clinical Research staff with all aspects of their responsibilities. May interface with regulatory agencies, as appropriate. Collaborate with Clinical Operations department to coordinate field staff and clinical site activities with study needs. Compile, review, and conclude device complaints. Provide management level representation during audits. Performs personnel related supervisory duties (e.g., performance assessments, development of staff goals and objectives).. Assist data management group with review of clinical data/information and provide oversight of data correction. Work with Clinical Customer Service to control device allocation, distribution, and reconciliation. Manages activities performed by Contract Research Organizations (e.g. CROs, core labs).. Oversees the clinical department SOP/DOP review and development, employee training, and associated requirements. Evaluate clinical data/information, write, and revise annual, interim, and final reports and clinical sections of Pre-Market Approval (PMA) submissions. May organize and direct investigator conferences to review findings and advise on study direction, as needed. Provide input and support for post-clinical activities and market launch of products. May co-author results of studies for medical literature and/or presentations at scientific meetings.
BioSpace.com - 2 years ago
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