A Clinical Compliance Manager job in Cincinnati, OH is available courtesy of Modis Engineering and Technology. The Clinical Compliance Manager will Develop Quality Control Plans and oversee/perform implementation of quality control activities for assigned projects according to committed timelines. You will also conduct Quality Control activities which include but are not limited to the following: Quality reviews of clinical trial protocols and associated documentation (including, but Informed Consent Documents, CRFs, Clinical Study Reports etc.), as appropriate, to ensure compliance with relevant standards/regulations.
Clinical Compliance Manager job responsibilities include:
• Review of Trial Master File to ensure accuracy and completeness of the documentation • Support the preparation, conduct and response to internal and external audits/inspections • Responsible for submitting metrics and meeting project timelines
• Prepare periodic quality control reports for assigned clinical projects, identify areas of risk and review and communicate trends with Clinical Trial Core teams
• A minimum of a Bachelors' Degree is required preferably in a Scientific or Technical Discipline
• A minimum of Eight years of experience in Quality Assurance in the Medical Device Regulated industry is required
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE). Strategic & tactical Clinical and Business knowledge to guide the organization in regulatory inspections is required. Strong communication, organizational and interpersonal skills are required. Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, etc.) is an asset
• Ability to effectively negotiate and influence upper management, affiliates and Regulatory Agencies to ensure that regulatory and business needs are met
If you are interested in this Clinical Compliance Manager job in Cincinnati, OH then please click APPLY NOW. For other opportunities available at Modis Engineering and Technology go to www.modis.com. If you have questions about the position, please contact Rod Grays at 317-558-8866 or firstname.lastname@example.org
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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