Clinical Compliance Manager

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Job ID Number: 2014009695 Location: USA - MN - Plymouth Job Description Position Summary The Clinical Compliance Manager is responsible for supporting and managing the Covidien clinical compliance strategy. In this key role, the Clinical Compliance Manager will establish and implement processes to ensure that clinical affairs research activities are conducted consistently and in compliance with applicable regulations and standards. In addition, the Clinical Compliance Manager will drive continuous improvement in all processes associated with the Clinical Compliance function. Utilizing their extensive clinical research expertise, the Clinical Compliance Manager will serve as an advisor and clinical research subject matter expert (SME) and will interact cross-functionally with multiple business-specific clinical affairs organizations. As a member of the Clinical Compliance leadership team, the Clinical Compliance Manager will collaborate closely with the Clinical Compliance Director and may represent both the director and department as needed. In collaboration with the Clinical Compliance Director, the Clinical Compliance Manager will be responsible for the following: Manage the coordination of the activities of the Clinical Compliance audit function; May act as lead auditor during internal audits of Covidien Clinical Operations (CCO), clinical vendors, clinical studies, and clinical sites as appropriate; Provide effective audit follow-up to ensure audit program effectiveness areas; Partner with CCO and business unit clinical study teams to identify, evaluate, and recommend solutions to issues identified in the performance of audits. Create and implementpolicies and procedures that are aligned with relevant global regulations and standards; Perform on-going evaluation to ensure compliance to current and future regulatory requirements. Identifythe training needs of CCO employees; Ensure training methods/tools are established and deployed and training records are maintained. Develop and implementtraining programs designated to increase awareness and knowledge of clinical compliance; May facilitate Good Clinical Practice (GCP) training for CCO and business unit clinical affairs personnel; May act as an advisor and best practice resource for clinical compliance, GCP, and SOP related issues; May act as SME during regulatory inspections. Provide expertise in and support trending of clinical compliance performance measurements to ensure the early identification of potential safety and/or compliance concerns. Identify and lead clinical compliance process improvement initiatives. Conductregular surveillance of the medical device regulations and standards which impact clinical research and Covidien; May support the interpretation of requirements. Up to 35% travel may be required as this position is supporting multiple clinical affairs locations. Requirements Bachelor’s degree required with biology, health care or engineering focus preferred. A minimum of 5 years’ experience directly supporting clinical research within a regulated environment, Minimum of 3 years of clinical compliance experience and at least 2 years of clinical research auditing experience. Medical device experience strongly preferred. Expertise in FDA, international regulations, and GCP. Demonstrated experience in operating a clinical quality system, implementing GCP compliance activities, and SOP management. Demonstrated knowledge of clinical research and product development processes. Experience supporting regulatory inspections. Experience working on and leading cross-functional teams. Excellent written and oral communication skills and ability to interface professionally and diplomatically throughout all levels of the organization. Ability to manage time efficiently and multi-task. Ability to prioritize tasks using a risk-based approach. Creative problem solving skills coupled with good judgment. Collaborative team player. - See more at:
Phama Job Categories: 
Clinical research and pharmacovigilance

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