Senior Manager / Site Director, Clinical Operations Adams ClinicalSenior Manager / Site Director, Clinical OperationsWatertown, MA$120,000–$150,000 / yearThe Senior Manager provides site-level leadership and operational ownership of clinical operations, with direct responsibility for staff management, study execution, regulatory compliance, strategic alignment with network leadership, and ensuring high-quality trial execution that meets sponsor expectations and business objectives. The Site Director assumes the same core clinical operations responsibilities while providing broader site-wide leadership through additional support of the Clinical Science function, clinician development, cross-functional performance, and integration of clinical science with site operations in partnership with Clinical Science leadership.
Sr.Clinical Operations Lead Integrated Resources, IncSr.Clinical Operations LeadCambridge, MassachusettsFull timeWorks closely with key scientific leaders, CRO global lead, Vendor Management, Operation Lead, study or program MDs, Program Directors, Study Management Team members including Regulatory Affairs, Medical Affairs, Commercial, Discovery, and Analytical Development. Chairs the [Study Management Team] in partnership with the CRO study Lead of the [Study Management Team]; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues.
Director/Sr. Director, Clinical Operations - Oncology Programs Frontier MedicinesDirector/Sr. Director, Clinical Operations - Oncology ProgramsBoston, MA$185,000–$250,000 / yearFrontier Medicines is seeking two experienced Clinical Operations leaders, at the Director or Senior Director level, to drive the operational strategy and execution of our oncology programs as they advance through clinical development. The ideal candidate brings deep oncology experience, strong global study oversight, and the ability to influence stakeholders, anticipate challenges, and deliver results in a dynamic biotech environment.
Senior Manager, Clinical Operations Adams ClinicalSenior Manager, Clinical OperationsBoston, Massachusetts$120,000–$140,000 / yearSupport subject recruitment, eligibility assessments, randomization, and oversee study processes including ALCOA-compliant documentation, study trackers, investigational product handling, and ensure proper handling of participant safety events and adverse events (SAE/AESI reporting). Oversee facility and building maintenance, including office services, safety inspections, drug room security, and pest control, while ensuring efficient use of site space and adequate workspaces for staff.
Project Manager, Clinical Research - New Site Build Iterative HealthProject Manager, Clinical Research - New Site BuildCambridge, MA$80,000–$110,000 / yearThis role is ideal for an experienced project manager who enjoys building new programs, thrives in highly cross-functional environments, and is passionate about expanding patient access to innovative cardiovascular clinical trials. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
Clinical Operations Lead Integrated Resources, IncClinical Operations LeadCambridge, MassachusettsContractorSecures operational excellence and delivery for one or more clinical studies by: • Developing operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country Lead • Overseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRO • Driving performance, quality, timelines and relationships through the CRO partnership model • Chairs the [Study Management Team] in partnership with the CRO study Lead of the [Study Management Team]; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues. Strives for effective, consistent, efficient and compliant processes by: • Championing best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group • Seeks interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phase • Follows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model • Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership model.
Clinical Research Associate Integrated Resources, IncClinical Research AssociateLexington, MassachusettsFull timeThe in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the Clinical Project Manager(s). Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items.
Clinical Research Manager Tufts UniversityClinical Research ManagerBoston, MassachusettsReporting to study leadership, this role provides study-wide project management and serves as the primary regulatory lead for the Tufts single IRB, coordinating across clinical operations, data management, laboratory operations, investigative project teams, documentation, training, and stakeholder communications. Serve as primary regulatory lead for the Tufts single IRB of record: prepare and maintain submissions, modifications, continuing reviews, reportable new information, consent revisions, reliance agreements, and the study regulatory binder; advise investigators and site staff on compliance strategy across sites.
Senior Project Manager, Clinical Operations Bicara Therapeutics IncSenior Project Manager, Clinical OperationsBoston, MAFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Ability to work independently and successfully in a fast-paced, results-driven, highly accountable environment with large potential impact; ability to prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively.
Clinical operations Lead Integrated Resources, IncClinical operations LeadCambridge, MassachusettsContractor2. Support operational excellence and delivery for one or more clinical studies by: • Managing the study operational strategy (SOS) with guidance from the lead COL or COS • Providing input to operational strategy (including ancillary vendors) aligned with the program strategy and working closely with the Clinical Country Lead (CCL) to set the country strategy, incorporating country input through the primary COL and study CCL • Overseeing the tactical execution of the operational strategy by the partner CRO; effectively providing oversight of the CRO, including close monitoring of CRO work on established baseline plans, highlighting areas in need of focus to assure issues are raised and resolved so baselines can be achieved • Utilizing operational expertise and scientific assessment to evaluate study feasibility: assess end point measurement options, and ensure the successful execution of study(ies). • Overseeing delivery of the study to budget 3. Strives for effective, consistent, efficient and compliant processes by: • Participating in best practice development in Phase planning and seeking opportunities for innovation and efficiency with the Clinical Study Leadership group • Following established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model; provides feedback via appropriate channels for opportunities to improve processes or set best practices (i.e. PON) • Embodying a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model.
Clinical Project Manager Integrated Resources, IncClinical Project ManagerLexington, MassachusettsContractorOur team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. Manage and document integration team meetings, drive timelines and deliverables, update trackers and management dashboards.
Senior Clinical Trial Manager, Patient Support Operations Sana BiotechnologySenior Clinical Trial Manager, Patient Support OperationsCambridge, MA$160,000–$200,000 / year8+ years of experience in clinical development operations or as a clinical research associate (CRA) with experience in transplant, apheresis, or cell therapy studies; direct experience working in the cell therapy or transplant space (e.g., former Transplant Nurse, Apheresis Nurse, or specialized Clinical Technician), with surgical experience a plus. The base pay range for this position at commencement of employment is expected to be between $160,000 and $200,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
Senior Project Manager, Clinical Operations Bicara TherapeuticsSenior Project Manager, Clinical OperationsBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Ability to work independently and successfully in a fast-paced, results-driven, highly accountable environment with large potential impact; ability to prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively.
Associate Director Clinical Operations Vor BioAssociate Director Clinical OperationsBoston, MA$195,000–$220,000 / yearThe ideal candidate will initiate and lead clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. The Associate Director will also work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure the successful execution of assigned projects.
Associate Director Clinical Operations Vor Biopharma Inc.Associate Director Clinical OperationsBoston, MA$195,000–$220,000 / yearThe ideal candidate will initiate and lead clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. The Associate Director will also work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure the successful execution of assigned projects.
Clinical Operations Manager Tessera TherapeuticsClinical Operations ManagerSomerville, MA$164,000–$199,000 / yearYou have previously demonstrated ability to partner with and proactively manage internal stakeholders, CROs, and vendors, and collaborate cross-functionally to deliver global clinical trials according to the planned timelines and budget, while ensuring quality in accordance with ICH-GCP guidelines and regulatory requirements. Bachelor's degree in a relevant scientific or healthcare discipline, with 8+ years of clinical operations experience, including 4+ years as a clinical trial manager, leading cross-functional teams and accountable for planning and executing global clinical trials.
NewClinical Study Operations Manager Beacon BiosignalsClinical Study Operations ManagerBoston, MassachusettsRemoteAs such, we're always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. As a Clinical Study Operations Manager within the Clinical Study Operations team, you will be responsible for ensuring the successful operational delivery of Beacon’s clinical studies, from startup through close-out.
Senior Clinical Project Manager Kiniksa Pharmaceuticals CorpSenior Clinical Project ManagerLexington, MA$170,000–$190,000 / yearManaging study-related vendors and serving as the primary point of contact for contracted CROs, study staff and contract labs; identifying potential risks and proactively resolving issues with CROs; establishing vendor management plans and reviewing quality metrics. The Senior Clinical Project Manager will provide operational expertise within the Research and Development function to ensure timely initiation, execution and reporting of clinical trials in accordance with ICH/GCP and all applicable requirements (including local regulations) to support licensure of products in the United States and global markets.
Senior Clinical Study Manager Integrated Resources, IncSenior Clinical Study ManagerCambridge, MassachusettsFull timeProvides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report. In collaboration with Study Execution Team (Takeda functions, Strategic Partners, and vendors), identify risks to study and develop risk mitigation plans, including communication and collaboration with Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.
Head Of Clinical Operations, Vaccines SanofiHead Of Clinical Operations, VaccinesWaltham, MA$293,250–$423,583.33 / yearSelected candidate will possess a proven track record of leading large, multifunctional clinical operations teams in the pharmaceutical or biopharmaceutical industry, including experience managing global clinical trials across multiple regions. Contribute to the Global Clinical Development Leadership Team, contributing to the GCD 2030 Roadmap, championing continuous improvement in processes and ways of working, and ensuring the function evolves to meet future scientific and operational demands.