- Takeda Pharmaceuticals (Boston, MA)
- …and perform trial simulations to provide innovative solutions and to optimize clinical trial designs. + Implement a quantitative decision making framework to ... ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions. + Strong statistical programming skills… more
- Sanofi Group (Cambridge, MA)
- …Plan (GCDP) and is accountable for the appropriate design, execution, and analyses of clinical trials within the GCDP. + The CRD will become an expert ... Clinical Science Operation (CSO) team to implement selected clinical trial (s) within the GCDP, including study...of this team in close collaboration with the Global Project Head (GPH) and Project Manager… more
- Pfizer (Cambridge, MA)
- …timely execution of First-in-Human (FIH) programs through proof-of-concept, delivering innovative clinical study designs and high-quality trial execution with ... and mutual trust. + Support the GDL and senior clinical scientist, in developing effective collaborations with project...results. + While generally not serve in an official manager role, may review the work of others within… more
- Dana-Farber Cancer Institute (Boston, MA)
- The ** Project Manager (PM)** will play a key role in overseeing the daily coordination and overall research project management of assigned Breast Oncology ... Agreements (MTA), Laboratory Service Agreements (LSA), Data Use Agreements (DUA), and Clinical Trial Agreements (CTA), are in place before transferring specimens… more
- Bristol Myers Squibb (Devens, MA)
- …cross-functional projects at the manufacturing site. Typical projects supported by this project manager role include site readiness for new launches, ... here at BMS with our Cell Therapy team. The ** Manager , Project Management, Cell Therapy** is responsible...perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of… more
- Bristol Myers Squibb (Devens, MA)
- …manufacturing and business process transformation. We seek a proactive, results-driven **Senior Project Manager ** for the site GoSolo deployment program. The ... and unique perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of passion, innovation, urgency,… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …and other applicable documents for budget builds and negotiations. + Responsible for Clinical Trial Management System (CTMS) budget builds and in a timely ... Under general supervision of the Clinical Research Budgets Manager , the ...**KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:** + Knowledge of the clinical trials lifecycle required. + Excellent written… more
- Beth Israel Lahey Health (Burlington, MA)
- …**Possesses direct knowledge and experience in the implementation of all aspects of clinical trials research complying with research SOPs, GCP, FDA and OHRP ... a difference in people's lives.** Under general direction, the Research Program Manager will be responsible for managing, promoting, cultivating and overseeing all… more
- Takeda Pharmaceuticals (Boston, MA)
- …apply advanced knowledge of CDISC standards (SDTM and ADaM), medical terminology, clinical trial methodologies to ensure the compliance with regulatory agencies ... and various other study documents and ensure they meet the study requirements; analyze clinical trial data by creating Tables, Listings and Figures using SAS as… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …Investigator(s), Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical ... study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal… more