Clinical Operations Manager
Proclinical is currently recruiting for a Clinical Operations Manager with a biotechnology company located in Cambridge, MA. Successful candidate will be responsible for ensuring compliance with applicable business and quality systems, regulations, and standards, as determined by the Director and in accordance with policies.
- Implement the Quality System, in conjunction with department leaders and Quality Management resources throughout; oversee Quality System maintenance and compliance.
- Oversee study trial activities, tracking progress against timelines; interact with study teams to identify and resolve issues.
- Manage relationships between vendors; review agreements and change orders; develop Functional Oversight plans.
- Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow-up and implementation of corrective actions.
- Participate in Quality System Audits (including internal and external audits) as needed to represent; conduct audit preparation activities and assure corrective action is performed in audit follow-up.
- Maintain and update, as necessary, quality-related documentation.
- Assure all team members are trained in the Quality System.
- Generate quality reports, utilizing statistics, as appropriate, for management review.
- Evaluate quality data trends that aid management in the identification and resolution of issues and overall quality improvement effort, including customer complaints, product nonconformance, and process deviations.
- Maintain current knowledge of, and compliance with, the full range of related quality systems, technology, regulatory requirements, and related policies and procedures.
- Act as the liaison to internal cross-functional operational teams, including Functional Quality Representative, Vendor Ambassador, Functional Learning Liaison, and Process Owner Network (PON) Ambassador.
Skills and Requirements:
- MBA, MPH, MS in information sciences or life sciences, or equivalent in a related medical, science or regulatory discipline required.
- Minimum of 2 years industry experience in healthcare-related sector, preferably clinical informatics/trials.
- Demonstrated proficiency in Project and Quality Management (Project Management Professional or Manager of Quality and Organizational Excellence certification preferred).
- Demonstrated proficiency with clinical trials data management systems.
- Demonstrated proficiency with Microsoft systems (Excel, PowerPoint, Word, and Project).
- Demonstrated proficiency in collaboration, team facilitation, and problem solving.
- Ability to be self-directed at the manager level with skills to influence others who are not direct reports.
- Demonstrated success in project or program management in a fast-paced environment.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Zachary Hines at (+1) 215-531-6914 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.