The Senior Director, Clinical Quality Assurance is responsible for establishing and implementing the strategy for the Clinical Quality Assurance (QA) function. This role is responsible for leading Good Laboratory Practices (GLP), Good Clinical Laboratory Practices (GCLP), and Good Pharmacovigilance Practice (GVP) QA activities including the development and execution of program or study level...

Associate Director/Director, Clinical Quality Assurance   PURPOSE OF JOB: Seeking an Associate Director/Director, Clinical Quality Assurance (QA) reporting to the SVP of Regulatory Affairs and QA. The successful candidate will work cross-functionally to develop and implement quality systems and processes to meet all US, EU, and global requirements. The position involves managing and...

Senior Clinical Trial Manager   Overview: We are seeking a highly skilled Clinical Trial Manager to lead and manage clinical trials in accordance with Good Clinical Practice (GCP) and regulatory requirements. The successful candidate will be responsible for ensuring that clinical trials are conducted efficiently, within budget, and in a timely manner, while maintaining high-quality data.   ...

Senior Clinical Trial Manager   Overview: We are seeking a highly skilled Clinical Trial Manager to lead and manage clinical trials in accordance with Good Clinical Practice (GCP) and regulatory requirements. The successful candidate will be responsible for ensuring that clinical trials are conducted efficiently, within budget, and in a timely manner, while maintaining high-quality data.   ...

**This position is not available for hybrid or remote work. All candidates will be expected to work on-site in Waltham, MA**   The Director, Pharmacovigilance (PV) Operations is responsible for tactical and strategic aspects of PV operations activities involving programs. This individual is accountable for ensuring compliance with and continuous improvement of PV process related to safety...

Reporting to the Vice President, Biometrics, the Associate Director, Clinical Data Management is responsible for leading all clinical data management activities for one or multiple projects including CRF design, database development, processing external data, medical coding, data review, SAE reconciliation, and database close/lock procedures in accordance with ICH Guidelines and company requiremen...