The Senior Manager, Quality and Regulatory Compliance provides leadership in the areas of clinical/non-interventional research regulations and human subject protection principals and their application to CorEvitas Clinical Registries. This individual will interact regularly with IRBs throughout the submission and approval process and will manage the development of policies and standards to assure the highest level of human subject protection, research compliance, and standardization of process. This role will be responsible for anticipating new or changing regulations and coordinating with internal stakeholders to develop strategies to address changes pertaining to the collection and reporting of real-world data. This role will also be responsible for developing and implementing a sustainable Quality Management System including the establishment of standards, processes and procedures, conduct of internal and external inspections, implementation of CAPAs, and the overall reporting of findings in support of delivery of the highest value to our subscribers.
Principle Duties And Responsibilities
- Operate as the primary point of contact for inspections, inquiries, notification, or other queries by regulatory authorities or current or potential subscribers.
- Develop, manage, and maintain appropriate policies and procedures to ensure regulatory compliance.
- Govern the development and maintenance of all controlled documents for Clinical Registries, such as protocols, ICF and patient -facing documents.
- Oversee the preparation and filing of all central IRB submissions for CorEvitas Clinical Registries studies throughout the lifecycle of a study; maintain excellent relationship with central IRBs.
- Serve as the regulatory subject matter expert in the development and execution of all projects, including new registry launches
- Conduct training for CorEvitas and site personnel in the areas of compliance and human research subject protection.
- Maintain all training files and training documentation.
- Conduct regulatory research and intelligence to keep project teams informed about the evolving regulatory environment and potential strategic implications.
Directly supervise 3 to 5 employees Skills/Knowledge
- Must be highly organized and detail-oriented, with excellent time management skills
- Must possess advanced written and verbal communication skills with the ability to read technical/regulatory procedures and write technical documents
- Must be able to communicate effectively to a wide range of internal and external clients at varying levels
- Must have the ability to solve practical problems while working in a complex environment
- Minimum of 6 years in a research setting
- Minimum of 2 years staff management experience
- Broad and deep understanding of pharmaceutical industry and regulations, specific to the conduct of observational studies and collection of real-world data
- Bachelors degree, preferably in life sciences, public health, health services research or related area required
- Graduate degree, including JD, highly preferred
- RAC credential preferred
- Attention To Detail
- Clinical Works
- Health Services Research