Sr./Clinical Trial Manager - Clinical Operations Aktis Oncology IncSr./Clinical Trial Manager - Clinical OperationsBoston, MAAktis' most-advanced program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies.
Senior Manager, TAT/Integration Clinical Operations Ipsen SASenior Manager, TAT/Integration Clinical OperationsCambridge, MAFor acquired company and/or asset Integration, this role will drive and manage clinical operations related integration activities to ensure successful onboarding of any new CDO members into Ipsen and/or ensure efficient and smooth transition of acquired clinical trials into Ipsen ways of working. This role will assess the clinical operations activities of the new asset, including gap analyses, and will prepare the transition plans in collaboration with the DDI & TAT CPD, and manage clinical operations-related integration activities to ensure effective integration and business continuity for any assigned clinical asset acquisition.
VP Business Operations & Partnerships Clinical Operations Alnylam Pharmaceuticals IncVP Business Operations & Partnerships Clinical OperationsCambridge, MA$301,800–$408,200 / yearThe Vice President, Business Operations & Partnerships is a critical executive-level role responsible for defining, governing, and scaling the operating model that enables Alnylam's Pipeline Delivery organization to execute on clinical trials with speed, quality, and predictability across a growing and increasingly complex portfolio. Vendor & Alliance Management: Define and execute a forward-looking, centralized vendor strategy, ensuring strong governance, clear accountability, and high-performing partnerships that enable speed, quality, and cost efficiency while keeping an enterprise lens.
Sr.Clinical Operations Lead Integrated Resources, IncSr.Clinical Operations LeadCambridge, MassachusettsFull timePartnering with GCO Vendor Management to escalate issues, sharing best practices and leveraging the Vendor Operations Relationship Manager for issue resolution• Initiates, leads and shares best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group• Identifies interdependencies and synergies with other trials and programs and seeks to proactively put into place process or forum to enhance excellence in 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; provides feedback via appropriate channels for opportunities to improve processes or set best practices (i.e. PON)• Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model• Is an advocate for the COL group and a visible contributor and vehicle to promote interaction• Is an influential leader and a resource for COLs within the Clinical Operations Management group.• Initiates and leads discussions at peer level forums relevant to the COL role and development in line with GCO best practices.• Able to influence MD on clinical study/program direction based on changing internal and external landscapes within phase, disease or therapeutic area; able to think strategically to best position a study within the current Clinical Development Plan.• Chairs SMT meetings and drives effective and efficient team operations through communication, goal setting and strategy implementation• Has a robust understanding of the study design including rationale, end points and patient population, and will ensure that the operational strategy supports both feasibility and scientific integrity• Develops and leverages Phase expertise (e.g.
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, TAT/Integration Clinical Operations ImCheck Therapeutics SASSenior Manager, TAT/Integration Clinical OperationsCambridge, MAFor acquired company and/or asset Integration, this role will drive and manage clinical operations related integration activities to ensure successful onboarding of any new CDO members into Ipsen and/or ensure efficient and smooth transition of acquired clinical trials into Ipsen ways of working. This role will assess the clinical operations activities of the new asset, including gap analyses, and will prepare the transition plans in collaboration with the DDI & TAT CPD, and manage clinical operations-related integration activities to ensure effective integration and business continuity for any assigned clinical asset acquisition.
NewClinical Study Operations Manager Beacon Biosignals IncClinical Study Operations ManagerBoston, MARemote$90,000–$110,000 / yearAs 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.
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 LeadOverseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRODriving performance, quality, timelines and relationships through the CRO partnership modelChairs 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 issuesPartnering with GCO Vendor Management to escalate issues, sharing best practices and leveraging the relevant vendor management member for issue resolution3. 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 groupSeeks interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phaseFollows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing modelEmbodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership modelAt least 10 years of clinical research study management experience of which at least 4 years has been with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations a plus.
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.
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.
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.
Sr Program Manager - Clinical Research Operations Northeastern UniversitySr Program Manager - Clinical Research OperationsBoston, MA$87,785–$123,998.75 / yearWe are seeking an expert Senior Program Manager of Clinical Research Operations to provide high-level operational, regulatory, and strategic management across multiple active research projects. With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role.
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 BioPharma IncAssociate 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.
NewClinical Study Operations Manager Beacon BiosignalsClinical Study Operations ManagerBoston, MassachusettsRemote$90,000–$110,000 / yearAs 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.
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.
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.
Director, Clinical Operations WhoopDirector, Clinical OperationsBoston, MA$210,000–$230,000 / yearLead operational oversight of CROs, technology vendors, recruitment partners, and other external service providers, establishing scalable governance frameworks, performance metrics, and escalation pathways to ensure high-quality delivery and accountability. Oversee Clinical Data Management and clinical trial technologies, ensuring high-quality, timely, and compliant data collection, management, and delivery across systems including EDC, CTMS, eConsent, ePRO, eTMF, and remote study platforms.
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 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.