We apologize for the inconvenience but the job you are looking for has been filled or it has been removed by the recruiter. For your reference, the original listing is shown at the bottom of this page.
Listed below are the top 10 out of 21 listings that are in the same industry and location as the job you were looking for. To see more than 10 listings, click here to search similar jobs in Kalamazoo, MI
Founded in 1982, Trialon Corporation was established to assist companies with their technical staffing needs. Trialon understands our clients have different ...
Majestic Systems Integration Co - Kalamazoo, MI US
Director of Clinical Information Services Job Summary: Our Client is located in western Michigan is searching for a Director of Clinical Information Systems. ...
Physical Therapist Manager of Outpatient Battle Creek, MI Agility Health is seeking a Manager of Outpatient Physical Therapist for our hospital in Battle Creek, ...
Join the nationally recognized Nursing Team at Borgess Medical Center in Kalamazoo, Michigan. Our 444 bed research amp; teaching facility offers the latest ...
Notify a Friend of this Job Opportunity : Ascension Health Information Services (AHIS) located at Borgess Health in Kalamazoo, MI is searchingfor a Director ...
Practice Clinical Care Coordinator Salary Range: Competitive Department: Hospitalist Service Schedule: Full time 80hrs/pp Shift: 1st shift Hours: 7:30a 4:30p ...
The JAG Group, Inc. is a national healthcare recruiting firm, specializing in the placement of permanent healthcare professionals across the country. We have ...
Borgess Health, a regional healthcare network, located in Kalamazoo, MI, includes more than 132 sites of care and 67 satellite clinics in 15 southern Michigan ...
For your reference, we have included the original job posting below.
Clinical Study Manager
Job Number:
42019386
Company Name:
Stryker Corporation
Job Location:
Kalamazoo, MI US
Job Categories:
Healthcare & Medical Science & Biotech
Clinical Study Manager
The Clinical Study Manager (CSM) is responsible for the day-to-day management of one or more clinical studies, to include, Standard Operational Procedures (SOPs), protocol development, Investigational Device Exemption (IDE), post-approval, post-market surveillance, feasibility, marketing studies, and/or investigator initiated studies. The CSM is also responsible for ensuring that assigned studies are being conducted in accordance with GCPs, FDA, ISO, ICH regulations and department SOPs. The CSM must provide greater support to the clinical group by taking on more studies, or studies of greater complexity under limited supervision. The CSM must provide clinical study guidance to less experienced CSMs, RND, Marketing, Regulatory Affairs and other multi-disciplinary teams. • Read and comprehend medical literature in the subject field in order to act as clinical representative to physician advisors, FDA, NB, internal and external consultants, and other Stryker departments • Lead multi-disciplinary teams and/or clinical project team • Design, develop and write clinical study protocols in conjunction with physician advisors • Manange contracts, schedules and budgets for study • Oversee Investigator qualification and occasionally perform Investigator qualification visits • Route Investigator Agreement and Financial Disclosure forms for approvals, when applicable • Facilitate Institutional Review Board (IRB) submissions of study protocol, Informed Consent, and other applicable documents • Lead and monitor device accountability process • Provide site training on study related tasks • Prepare and maintain patient recruitment and retention strategies • Prepare monitoring plan, review and follow up on monitoring visit reports, may conduct monitoring visit, when required • Oversee Clinical Research Organization (CRO) conduct of monitoring visits. Solve issues and give direction to CRO and sites • Review and monitor study protocol deviations • Conduct risk analysis and monitor reported adverse events • Serve as primary contact between study site personnel and sponsor regarding study-related issues • Collaborate with Data Management and Clinical IT groups on Case Report Form (CRF) design, final CRF approval, clinical study database set-up, edit checks, User Acceptance Test, data entry Quality Control (QC), data review, and SAS reports • Oversee review of incoming CRF study data • Reviews radiographic data , participates in imaging reviews when applicable • Track study metrics on site performance, devise and implement corrective actions • Lead data review process • Prepare periodic study status reports for sites and maintain open communication with sites • Prepare annual study progress reports and final reports, to include clinical and radiographic data, for FDA, Investigators, IRBs and Ethics Committees • Assist Investigators with manuscript preparation for submission to peer reviewed journals or podium presentations • Initiate and Oversee investigator initiated clinical studies including setting and managing research agreement deliverables and aligning with Stryker's research goals. • Oversee study close-out visits • Select study files for QC, approve QC plan and follow up on QC findings • Support Regulatory Affairs in submission of IDEs, post-market approval applications, amendments, supplements and other regulatory submissions with regard to clinical issues • Oversee study file preparartion and archival processes • Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker IMT Business Process Notation and intigrated Quality Management System (iQMS) initiatives
Qualifications/Work Experience
•Minimum 5 years experience in clinical research with 3 years of experience as Clinical Study •Experience in clinical study management in medical device field preferred US & OUS knowledge •Working knowledge of Good Clinical Practices (GCPs) and Food and Drug Administration (FDA) and ISO/ICH medical device regulations and guidelines •Ability to summarize clinical data from literature, media and raw data listings •Strong written and verbal communication, analytical and interpersonal skills •Highly organized and detail-oriented •Self-starter with initiative and strong project management skills •Team based work experience preferred •Working knowledge of personal computer systems and desktop office applications •Experience with clinical data systems such as relational databases and reporting systems
Education and/or Special Training
Four-year degree in sciences or health-related field is required, advanced degree preferred. Manager, Clinical Project Manger or equivalent
