Advanced Clinical

Provide GCP guidance for clinical research activities and drive continuous improvement in all processes associated with the clinical compliance function.. GCP Clinical Trial Audit Support: Key lead player in the preparation and overall support for internal/external audits as liaison with QA including responding to audit findings on behalf of the organization and performs pro-active internal compliance assessments.. GCP audit and CAPA experience required.. Experience with Nutrition Research preferred.. Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

quality manager

Overview We are currently searching for a skilled professional to join a well-known client’s team as a Remote Clinical Quality Manager. The Clinical Quality Manager will formulate, and lead compliance efforts, initiatives, and strategies related to clinical research. Ensure a state of readiness for internal and external audits and inspections of clinical studies. Promote and instill a culture of quality initiatives embedded in studies (whether conducted internally or in collaboration with a CRO) from the outset to minimize audit findings and ensure quality. Lead SOP initiatives geared toward quality improvements for the group. Responsible for supporting Clinical Development (CD) staff globally in ensuring compliance with company policies and procedures and GCP regulations/guidelines and any other applicable requirements. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. Responsibilities <ul><li>SOP Strategy and Development: Lead revision and development of standard processes for the Clinical Development Team to ensure that all clinical research activities are conducted consistently and in compliance with applicable regulations and standards. Provide GCP guidance for clinical research activities and drive continuous improvement in all processes associated with the clinical compliance function. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Assure SOPs appropriately reflect Corporate and Divisional policies.</li><li>GCP Clinical Trial Audit Support: Key lead player in the preparation and overall support for internal/external audits as liaison with QA including responding to audit findings on behalf of the organization and performs pro-active internal compliance assessments. Oversee audit plans, audit reports and implement any necessary corrective or preventative actions to meet procedural or regulatory compliance requirements. Support project teams should investigational sites need support in preparing for an internal or external audit or an authority inspection. Conducts annual internal monitoring for scientific research funding.</li><li>Vendor Qualification/Audits: Lead and conduct all clinical supplier/vendor qualifications and maintenance on the approved supplier list per corporate and divisional expectations. </li></ul>Experience <ul><li>Education: Bachelor’s Degree (± 16 years) preferably in Life Sciences or an equivalent combination of education and work experience</li><li>Minimum 5 years preferably in medical devices, clinical research experience, or related industry. At least 3 years of related work experience in a Quality role in pharma, medical device area and/or related clinical trial environment. GCP audit and CAPA experience required. Experience with Nutrition Research preferred.</li><li>Fluent in English, any additional major language is a preferred asset; Excellent Communicator; Computer Literate. Ability to travel domestically or internationally as needed for the job responsibilities. </li></ul>EDUCATION <ul><li>Bachelor’s Degree (± 16 years) preferably in Life Sciences or an equivalent combination of education and work experience </li></ul>About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available. 508579

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