Post Market Studies Manager

Division: Atrial Fibrillation Division (AFD) Location: Minnetonka, MN 55345 Status: Full Time, Employee Job Category: Marketing/Product Work Experience: 7+ to 10 Years Education Level: Bachelor's Degree Career Level:Manager (Manager/Supervisor of Staff) Company:St. Jude Medical Post Market Studies Manager Manager, Post-Market Studies Manages Post-Market Clinical Research Associates •Responsible for hiring and retaining a diverse, highly qualified staff and for providing career coaching, growth and personal development •Accountable for the development of staff through critiques, instruction, mentoring, evaluation, and coaching •Accountable for the performance of subordinates or the work output of managed subcontractors •Maintains a safe working environment and a strong customer focus •Models optimum leadership competencies to inspire an energized, empowered, and accountable work force, ethical behavior, favorable community image, and actualization of the SJM Guiding Principles and AFD management values.Organizes and supervises new clinical studies. •Acts as primary author for clinical study protocols and supporting documents (informed consent, case report forms, training materials, etc) •Investigator, IRB and IACUC approval contacts for both human and animal studies. •Primary responsibility for recruitment, selection, and training of clinical investigators with respect to protocol and data submission requirements. •Supervises the design and administration of computerized databases. •Provides technical assistance to centers (assist with initial procedures, etc.). •Represents the clinical department on new product development teams. •Drafts and obtains nondisclosure, investigator agreement, research contract and financial agreements and investigator financial disclosure. •Visits sites for pre-investigational reviews. •Responsible for safety committee (e.g., DSMB) member selection, member communication, contracts, etc. •Responsible for management of core labs (core lab selection, contract negotiations, etc.) •Responsible for planning Investigator Meetings Supervises ongoing clinical studies. •Performs site initiation visits and close out visits •Performs on-site monitoring/audits of source documents and study compliance at each investigational site as defined by the Clinical Investigation Plan. •Monitors data input/database maintenance activities of database team during ongoing clinical studies. •Responsible for accurate, complete and timely data submissions by clinical investigators and implementation of corrective action, if necessary. •Administers/oversees investigational site compensation programs. •Supports investigators wishing to publish or present their experience with company products. •Prepares and submits forecasts of investigational devices to Manufacturing to assure adequate supply, and maintains records of device shipment and storage. •Reports and gains approval for any protocol changes or deviations. •Reviews clinical data for completeness and identifies any adverse effects. •Reports unanticipated adverse effects to Regulatory Affairs personnel. •Provides in-house (Sponsor) audits of clinical studies Qualifications •B.S. in biological or medical/clinical sciences or Marketing •7 or more years related experience in drug, and/or medical device clinical studies, or equivalent, preferably with 1-3 years of management experience •Excellent communication and interpersonal skills with demonstrated ability to maintain ongoing communications with department staff, clinical study site personnel, and other SJM employees. •Working knowledge and experience with statistical concepts and principles. •Demonstrated ability and/or experience in physician/patient contact. •Computer literacy. •Has knowledge of IDE, PMA, 510(k) or equivalent and GCP procedures. •Must be able to travel up to 50%  Qualified candidates may apply online via our website via our website at www.sjm.com and reference position AF11758.  Apply Now! St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.