New Jersey, US; Cambridge, US; Gaithersburg, US | full time | Job ID: 10662 The Director, Global Clinical Operations...” within BNT pipeline. Ensure consistent, high quality execution across compounds and vendors. Global study management and vendor...
Director, Country Operations Management (AD COM), you will report to the Director, Study Start-Up and Site Partnership and play... manager for designated local functions, as agreed with the Study Start-Up and Site Partnership Director...
Job Description General Summary: The Clinical Development Associate Medical Director will serve as the Medical Lead... to achieve efficient, high-quality study execution Participates in the preparation of regulatory documents in support...
with high standards of quality and consistency while maintaining compliance with GCP regulations. You will oversee Olema... and other presentations . About the Role Director, Clinical Monitoring Oversight As the Director, Clinical Monitoring Oversight...
a Senior Director of Medical Affairs to support our lead oncology program as it enters its first pivotal study. Reporting..., managing budgets and timelines, and ensuring high-quality deliverables across medical information, field operations...
Job Description General Summary: The Medical Affairs Senior Director provides medical and scientific leadership... integrity Ensures compliance at country level with company policies, medical affairs SOPs, GCP and ICH Assesses local...
, Biometrics, the Associate Director of Clinical Data Management will be responsible for leading the clinical data management... at collaboration, and is passionate about ensuring high-quality clinical data to drive impactful decision-making. Your Role: Lead...
and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical..., ensure quality data and conduct review of emerging clinical data and trends; review and query data; present and discusse...
compliance with GCP and GMP principles, as well as Quality Management Systems. Coordinate and compile regulatory documents... and Operations is preferable. Deep knowledge of GCP and GMP principles, including SOPs, documentation, and ethical standards...
reports into Associate Director of TMF Operations (or above). This role maintains the TMFs ensuring they are current... for managing clinical document quality/control/review, and the Trial Master Files (TMFs). Performs set up activities...
with regulatory requirements, and in accordance with the study protocol. This position will report to our Director, Clinical..., ICH-GCP). Collaborate with data management teams to track case report form (CRF) completion and query resolution. Ensure data...
of the team’s timeline management, clinical quality assessment and trial operations integrity and for ensuring Sponsor... productivity and quality of work produced by assessing work effort on individual studies. Management Team Responsibilities...
to join our organization as a Senior Manager, Clinical Outsourcing and Vendor Management. This position reports to the Senior Director... goals, regulatory requirements, timelines, and quality standards. Your Role: Provide primary outsourcing and vendor...
analysis Ensuring smooth and efficient running of the clinical trial as per good clinical practices (GCP) guidelines... in consultation with the research director. Collecting, documenting, and managing study data (study questionnaires and qualitative...
Medical Director, Clinical Development. Your Role: Support the clinical development of investigational oncology therapies... requirements and Good Clinical Practice (GCP) Collaborate with data management, clinical operations, biostatistics...