- Actalent (Lexington, MA)
- We are seeking a dedicated TMF Project Manager who will provide day-to-day record management support across various teams, ensuring smooth operations in ... Clinical Operations, Clinical Development, and Data Management. + Offer TMF oversight to CROs and act as the initial...and act as the initial point of contact for TMF process-related inquiries. + Attend routine clinical trial meetings… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Research Project Manager (RPM) is responsible for assigned day-to-day coordination and overall management of activities for assigned clinical trials. ... Responsible for development and maintenance of Trial Master File ( TMF ) and regulatory files of assigned projects + If...overall management of several assigned trials. + Assist senior manager (s) in the development of a project … more
- Astrix Technology (Boston, MA)
- **Senior Clinical Project Manager ** Clinical Project Manager /Scientist Boston, MA, US Pay Rate Low: 150000 | Pay Rate High: 180000 + Added - 16/01/2025 ... Apply for Job Seeking a **Senior Clinical Project Manager ** for our client - a...Oversee study activities, including reviewing monitoring reports and conducting TMF (Trial Master File) checks. + Attend status meetings,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …role is not eligible to be fully remote is not available._ The ** Manager Clinical Study Lead** (CSL **)** may perform the following responsibilities with moderate ... forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. ... to Clinical Trial Management System (CTMS), Trial Master File ( TMF ) etc. + Ensures compliance with the clinical trial...delivering per the scope of work + Ensure clinical project audit and inspection readiness through the study lifecycle… more
- BeOne Medicines (San Mateo, CA)
- …on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at ... QC'd on a regular basis as per the study TMF QC plan + Provides input to Global Clinical...Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues… more
- BeOne Medicines (Emeryville, CA)
- …to study start up and site activation plans + Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ) are ... QC'd on a regular basis as per the study TMF QC plan + Collaborates closely with Global Clinical...study life cycle + Ensures clinical studies at a project level are executed within endorsed time, quality, and… more
- Abbott (Alameda, CA)
- …for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Participate in cross-functional clinical team(s) in the planning ... conduct of the study (such as Trial Master File ( TMF ), Clinical Protocols and Reports). + May interact with...to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on… more