- Merck & Co. (Boston, MA)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... insight into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human… more
- Merck & Co. (Boston, MA)
- … clinical bioanalysis.Required Skills: Anatomic Pathology, Biomarker Development, Clinical Studies , Digital Pathology, Molecular PathologyPreferred Skills: ... Molecular Biomarkers is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of … more
- Parexel (Boston, MA)
- …programming is required. The candidate will develop, drive, and handle clinical study related tasks for the team in collaboration with Precision Medicine ... Maintain and review metrics related to clinical study samples, data, kits, and logistics. - Lead...and issues with an awareness of the impacts to clinical studies /program. - Strong problem-solving, project management,… more
- Parexel (Boston, MA)
- …Purpose:** The Clinical Quality Operations Manager (CQOM), in collaboration with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality ... Tools (RACT) and Quality Plans in partnership with the Clinical Trial Team (CTT). + Collectively and...with Client QA and acting as the link between Clinical Development, study teams, global business functions… more
- Parexel (Boston, MA)
- **Job Summary** The Patient Compensation Lead in Clinical Development & Operations will be responsible for ensuring all processes and vendors are in place to ... services + Coordinate with Site Payments and Contracting teams to manage mixed-model studies + Lead process improvement initiatives for all aspects of… more
- Parexel (Boston, MA)
- …monitoring activities according to MMP during the study conduct + Answer to site/ study team questions relating to the study conduct or protocol + Review ... Medical Director to join Parexel's highly recognized Medical Sciences Team as we continue to grow our Global Immunology.... + Participate in the development and/or review of study documents, such as clinical protocols, Medical… more
- Parexel (Boston, MA)
- …are seeking a dynamic and experienced Data Management Lead to join our team . If you have a passion for clinical research, strong project management skills, ... **Job Title:** Data Management Lead (Medical Affairs) - Oncology **Location:** Fully Remote...study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good… more
- CSL Behring (Waltham, MA)
- …contributes and builds effective relationships with respective members of Product Strategy Team (PST), Clinical Development Team (CDT), Safety Management ... and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL...Could you be our next Senior Manager Regional Regulatory Lead , Vaccines? The job is in our Waltham MA… more
- Parexel (Boston, MA)
- …Sponsor SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international ... and accuracy according to Sponsor standards. - Work with lead writer and project team to develop...of documents, including but not limited to investigator's brochures, clinical study protocols and reports, integrated summaries,… more
- WuXi AppTec (Boston, MA)
- …evaluating clients' development programs; and preparing project proposals and preliminary study designs based on compound characteristics, clinical indications, ... the **Toxicology Commercial Operations Center (TOX COC) Project Management team ** , based in US as a remote employee....trial plans, existing data, and target submission regions. + Lead and manage the nonclinical portion of IND-enabling programs:… more
- Parexel (Boston, MA)
- …guidelines, SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international ... and accuracy according to client standards.. + Work with lead writer and project team to develop...of documents, including but not limited to investigator's brochures, clinical study protocols and reports, integrated summaries,… more
- Parexel (Boston, MA)
- … aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred + Clinical practice experience + Good knowledge ... the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our...background in Ophthalmology to join our Global Medical Sciences team .** **The role can be based remo** t **ely… more
- Orchard Therapeutics (Boston, MA)
- …and will serve as a key member of the Medical/ Clinical Development (MCD) leadership team . Responsibilities . Lead the Clinical Science team on ... development, the clinical development plans, managing the clinical studies , drive the regulatory documentations/presentations, writing and executing… more
- Sanofi Group (Cambridge, MA)
- …devices, etc.) + Works with cross-functional teams, including medical leads, global study lead , statisticians, clinical supply managers, regulatory affairs ... support the end-to-end data management digital transformation in our clinical studies . This role will be pivotal...+ Be the Data Management leader in the cross-functional study team and oversee study … more
- Sanofi Group (Cambridge, MA)
- …limits of what you thought was possible. Ready to get started? **Main Responsibilities** + Lead the cross-functional study team and oversee global study ... critical in helping our teams accelerate progress. Join our Clinical Science Organization as an **AI-Enabled Global Study...patient-centric trials. This role is a unique opportunity to lead innovation and impact clinical operations while… more
- Sanofi Group (Cambridge, MA)
- …plan through internal management review + Lead a clinical sub team to design clinical studies and to create study protocols + Execute the ... development plans and studies + Align clinical development strategy with the global project team... study execution + Oversee the execution of clinical studies in compliance with internal SOPs,… more
- Sanofi Group (Cambridge, MA)
- …individual will also serve as Study Medical Manager (SMM) for selected clinical studies . SMM principal duties and responsibilities include:** Study ... **Job Title:** Clinical Lead , Early Clinical ...contracts, regulatory documents, etc.). + Coordinate clinical team to set-up and follow the study .… more
- Parexel (Boston, MA)
- …programming is required. The candidate will develop, drive, and handle clinical study related tasks for the team in collaboration with Precision Medicine ... Maintain and review metrics related to clinical study samples, data, kits, and logistics. * Lead...and issues with an awareness of the impacts to clinical studies /program. * Strong problem-solving, project management,… more
- ConvaTec (Lexington, MA)
- …and Convatec's policies and SOPs. **Key Responsibilities:** + Working closely with Clinical Study Managers (CSMs) and Clinical Research Associates ... and management of Clinical Research Organizations (CROs) and other vendors for clinical studies that are outsourced to third party vendors (with the… more
- Pfizer (Cambridge, MA)
- …and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation ... members of the development team to establish, lead , coordinate, and execute the early oncology clinical...Early Stage Development (OESD) is represented as need within clinical study teams (eg Research Units, Biostatistics,… more
