- Rhythm Pharmaceuticals (Boston, MA)
- …tenacity to overcome barriers, together. Opportunity Overview Rhythm Pharmaceuticals, Inc. is seeking a Senior Trial Master File (TMF) Specialist to join ... an integral member of the Clinical operations team, reporting to the Senior Director of Clinical Process and Quality-Control Management, (CPQM). This position will… more
- Takeda Pharmaceuticals (Boston, MA)
- …and oversight models. + Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. + Participate in preparing ... to inspire you and empower you to shine? Join us as a Senior Manager, Clinical Trial Tools & Technologies based remotely reporting to the Clinical Trial … more
- Actalent (Boston, MA)
- …study document filing, maintaining study trackers, and oversight of the study-specific electronic Trial Master Files (eTMF). Responsibilities + Serve as a member ... Job Description The Senior Clinical Trial Associate (Sr. CTA)...including tracking investigator/institution/vendor payments. + Review, validate, track, and file essential documents for investigational sites, following up on… more
- Astrix Technology (Boston, MA)
- …+ Oversee study activities, including reviewing monitoring reports and conducting TMF ( Trial Master File ) checks. + Attend status meetings, ... ** Senior Clinical Project Manager** Clinical Project Manager/Scientist Boston,...experience, including at least 3 years as a Clinical Trial Manager (CTM) or Clinical Trial Project… more
- Takeda Pharmaceuticals (Boston, MA)
- …inspection or audit.** **Ensure archival and inspection readiness of all Data Management Trial Master File (TMF)** **documents.** **Ensures achievement of ... application is true to the best of my knowledge. **Job Description** ** Senior Manager, Clinical Data** **Management** **Objective / Purpose:** **The Senior … more
- Takeda Pharmaceuticals (Boston, MA)
- …inspection or audit. + Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. + Ensures achievement of major ... to the best of my knowledge. **Job Description** Objective / Purpose: The Senior Manager Clinical Data Management is responsible for timely and high quality data… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience in clinical trial management/operations preferred. + Expert level expertise with trial master file technology. + Expert level expertise with ... company to inspire you and empower you to shine? Join us as a Senior Manager, Business System Lead based remotely reporting to the Director, Structured Content… more
- Actalent (Boston, MA)
- …as a functional manager for Clinical Trial Assistants (CTAs) and assist with electronic Trial Master File (eTMF) and high-level CTA tasks as needed. This ... inclination towards mentoring and leading by example. Experience with Trial Interactive is essential. The main responsibility is managing...a team ranging from CTA 1, CTA 2, to Senior CTA. Responsibilities + Manage and mentor a team… more
- Dana-Farber Cancer Institute (Boston, MA)
- …oversight and management of assigned projects. + Responsible for development and maintenance of Trial Master File (TMF). + Initiates, plans, facilitates and ... sponsor activities for assigned clinical trials Sponsor activities include coordinating trial startup and site startup activities, safety event tracking and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …oversight and management of assigned projects. + Responsible for development and maintenance of Trial Master File (TMF), + Assists PI with protocol and ... trials; primarily multi-center, PI-initiated trials. Sponsor activities include coordinating trial startup and site startup activities, providing training to… more
- Sanofi Group (Cambridge, MA)
- …raised by EC/IRBs, sites + Develop the clinical study report + Support CRD trial master file documents readiness and availability, and mandatory trainings ... Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data,...knowledge of the study, compound, protocol + TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs… more