Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Clinical Quality Manager I
Description
Delivering on the promise of medical innovation begins at Boston Scientific
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Responsible for the management of the Clinical Quality Assurance function in assigned business area(s) in line with strategies and goals set by global CQA management. Ensures clinical research activities conform to federal and international regulations and BSC procedures and expectations.
Responsibilities:
· Manages the clinical audit program in assigned business areas. Ensures audits are performed according to the audit schedule and assigns resources.
· Maintains the audit schedule and analyzes audit findings for trends.
· Reviews SOPs to assure compliance with regulations and BSC policies and procedures.
· Provides input to training function and, where appropriate, gives training on issues identified during audits.
· Develops clinical audit procedures and processes.
· As needed, assists with internal and external audits (internal systems, trial master file, investigator sites, clinical service providers) to assess the accuracy and quality of scientific data collected, and to determine the level of compliance with applicable regulations.
· Reviews audit reports for accuracy and consistency.
· Supports the preparation, coordination, and management of regulatory agency inspections of BSC offices. During inspection, plays lead role as facilitator and communicator.
· Prepares investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings.
· Keeps abreast of regulatory requirements, and updates management on the possible ramifications of regulatory changes.
· Develops department plans and budgets, and monitors spending.
· Recruits, trains, supports, and develops junior Clinical Quality Assurance staff (Auditors and Specialists).
· Performs and/or manages vendor assessment/qualification audits prior to contract initiation.
· Participates in due diligence evaluations and audits of potential outside collaborations, joint ventures, acquisitions, or in-licensed products.
· Participates in periodic site visits to assess the site’s understanding of GCPs and protocol requirements.
· Assists in training Clinical Affairs staff and/or contractors, as needed.
· Summarizes and analyzes data for trends.
· Reviews essential documents such as protocols, CRFs, and informed consent forms for adequacy and compliance with GCP and regulations.
· Engages, trains, and supervises contract auditors, as necessary.
· Establishes and supports a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for Clinical Quality Assurance.
· Ensures all employees are trained to do their work and their training is documented.
Qualifications:
· Bachelor’s degree in science or health-related field required; advanced degree preferred.
· Minimum of 7 years’ experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines; 3 years’ QA and/or compliance experience; 2 years’ auditing experience; international experience a plus.
· Minimum of 3 years’ management experience in quality assurance or clinical trial operations required
