Manager, User Guide Strategy and Operations (Hybrid-Acton, MA or San Diego, CA) Insulet CorpManager, User Guide Strategy and Operations (Hybrid-Acton, MA or San Diego, CA)Acton, MA$144,500–$216,800 / yearThe manager leads a team of senior independent contributors and contract technical writers while serving as the primary user guide representative for cross-functional stakeholders, including Product, Engineering, Medical Affairs, Regulatory Affairs, Human Factors, Quality, and external partners. The Manager, User Guide Strategy and Operations serves as a senior leader within the user guide function and is responsible for portfolio ownership, people leadership, delivery execution, and operational excellence across a portfolio of Omnipod products and programs.
NewClinical Trial Manager (Contract) Centessa Pharmaceuticals PlcClinical Trial Manager (Contract)Boston, MA$65–$90 / hourDrive critical study milestones, including site activation, enrollment progress, patient retention, data cleaning, and database lock, proactively addressing operational challenges common to CNS trials. Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders.
Clinical Trial Manager Actalent IncClinical Trial ManagerWaltham, MARemote$85–$91 / hourThe Clinical Trial Manager leads the planning, execution, and delivery of Phase 1 clinical studies in healthy volunteers, including first-in-human (FIH), single and multiple ascending dose (SAD/MAD), food effect, bioavailability/bioequivalence (BA/BE), human abuse potential (HAP), thorough QT (TQT), drug-drug interaction (DDI), and other early-phase studies. This role oversees end-to-end study operations, manages vendors and clinical partners, ensures regulatory compliance and inspection readiness, and collaborates closely with cross-functional teams to support clinical development objectives.
Associate Director Drug Product Technical Operations Vor Biopharma Inc.Associate Director Drug Product Technical OperationsBoston, MA$170,000–$195,000 / yearDrug Product and Combination Product Integration: Partner closely with the Combination Product Development Lead to ensure alignment between drug product characteristics, primary container systems, prefilled syringes, needle safety devices, autoinjectors, fill-finish processes, device performance, and product presentation requirements. This role will have end-to-end accountability for drug product manufacturing from late-stage development through commercialization, including manufacturing strategy, technology transfer, aseptic fill-finish, process validation, lifecycle management, commercial readiness, and Drug Product Module 3 content.
Senior Manager/Associate Director, Portfolio & Strategy Operations Relay Therapeutics IncSenior Manager/Associate Director, Portfolio & Strategy OperationsCambridge, MABuilt on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. The Opportunity: As the Senior Associate/Associate Director of Portfolio and Strategy Operations, you will help ensure flawless operation of activities for a first-in-class program as it moves through clinical development while reporting to the Director of Portfolio Strategy and Operations.
Regulatory Coordinator - Neely Center For Clinical Cancer Research Tufts MedicineRegulatory Coordinator - Neely Center For Clinical Cancer ResearchBoston, MA$21.53–$26.91 / hourIn addition, this role focuses on performing the following Administration Project Management duties: Serves as a liaison between the general project management office and the team members engaging in planning, reviews the status of projects and budgets, manages schedules, prepares status reports, and assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction. Works collaboratively with a variety of personnel at all levels, including faculty and study team members of the Neely Center for Cancer Clinical Research (NCCCR) and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations.
Sr. Manager, Promotional Planning & Marketing Operations Vericel CorpSr. Manager, Promotional Planning & Marketing OperationsBurlington, MA$140,000–$160,000 / yearThe Senior Manager, Promotional Planning and Marketing Operations leads Vericel's marketing operations, including the Medical, Legal and Regulatory (MLR) review process, and provides centralized coordination across key Commercial initiatives. The role ensures all promotional resources, programs and campaigns move efficiently from planning through review, approval and execution in accordance with prospectively established timelines and while maintaining appropriate quality and compliance.
Senior Director, Biomarker Development, Strategy And Operations Zenas BioPharmaSenior Director, Biomarker Development, Strategy And OperationsWaltham, MA$227,000–$283,785 / yearZenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcRIIb monoclonal antibody. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases.
System Director Pharmacy Business Operations Tufts Medicine Tufts MedicineSystem Director Pharmacy Business Operations Tufts MedicineBurlington, MA$162,773.52–$207,541.52 / yearComprised of Tufts Medical Center, the principal teaching hospital of Tufts University and the Tufts University School of Medicine, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home, and an integrated network of 2,300 physicians, we treat the most complex conditions, keep our communities healthy and bring research breakthroughs to life. Responsibilities typically include: ownership of short to mid-term (1-3 years) execution of functional strategy and the operational direction of the Department, problems faced are often complex and require extensive investigation and analysis, and requires ability to influence others to accept practices and approaches, and ability to communicate and influence executive leadership.
Senior Manager, Integrated Clinical Trial Data Process Excellence and Delivery LancesoftSenior Manager, Integrated Clinical Trial Data Process Excellence and DeliveryCambridge, MA$75Facilitate cross-functional workshops and subject matter expert interviews to gather requirements, document process steps, clarify roles and handoffs, and confirm proposed content. Experience facilitating cross-functional workshops and subject matter expert discussions to gather requirements, clarify roles and handoffs, and confirm proposed process content.
Clinical Trial Manager Centessa Pharmaceuticals PlcClinical Trial ManagerBoston, MA$120,000–$150,000 / yearDrive critical study milestones, including site activation, enrollment progress, patient retention, data cleaning, and database lock, proactively addressing operational challenges common to CNS trials. Lead day‑to‑day clinical trial operations, coordinating cross‑functional partners (Clinical Development, Data Management, Biostatistics, Regulatory, Safety) to ensure efficient trial execution and alignment to program objectives.
Clinical Research Coordinator Alcanza Clinical Research LLCClinical Research CoordinatorMAScheduling subjects for study visits and conducts appointment reminders; Building/updating source as needed; Conducting monitoring visits and resolves issues as needed in a timely manner; Ensuring study related reports and patient results are reviewed by investigator in a timely manner; Filing SAE/Deviation reports to Sponsor and IRB as needed; Documenting and reporting adverse events; Reporting non-compliance to appropriate staff in timely manner; Maintaining positive and effective communication with clients and team members; Always practicing ALCOAC principles with all documentation; May assist with study recruitment, patient enrollment, and tracking as needed; Maintaining confidentiality of patients, customers and company information, and; Performing all other duties as requested or assigned. Responsibilities may include but are not limited to: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Requesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies;].
Clinical Trial Manager II Summit Therapeutics IncClinical Trial Manager IICambridge, MA$122,000–$145,000 / yearHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. Drafts, reviews and manages study related plans, processes including Informed Consent Forms, Investigator agreements (CTA), CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plan, data management, and safety monitoring as delegated.
Manager Clinical Data Monte Rosa Therapeutics IncManager Clinical DataBoston, MAThis individual will work closely with Clinical Operations, Biostats and Programming, Medical, Safety, Regulatory, external CROs, and technology vendors to ensure high-quality, inspection-ready clinical data. Manage CROs, EDC vendors, central labs, imaging vendors, eCOA providers, IRT vendors, and other data providers.
Clinical Trials Associate Monte Rosa Therapeutics IncClinical Trials AssociateBoston, MAAssist with the management of tracking, logistics and quality operations for biological samples to help ensure that sample inventories are accurate and up to date. BA/BS degree required with a minimum of 2 years relevant clinical research experience working at an Investigator Site, Sponsor or Clinical Research Organization.
Field Clinical Engineer - East EBR Systems IncField Clinical Engineer - EastBOSTON, MA$130,000–$180,000 / yearBuild strong relationships with investigators and site staff, acting as a trusted liaison between clinical sites and EBR Systems' clinical, regulatory, and R&D teams on site feedback and product insights. Essential duties and responsibilities include, but are not limited to, the following: Support all aspects of clinical study execution, including recruitment, site start-up, enrollment, and follow-up visits at assigned sites.
Senior Clinical Trial Specialist Contract Centessa Pharmaceuticals PlcSenior Clinical Trial Specialist ContractBoston, MA$65–$85 / hourAssists in tracking key site metrics and milestones such as Site Initiation Visits and site activation, subject recruitment and enrollment, critical study dosing days and assessments, scheduled Monitoring Visits and Close-Out Visits etc. Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders.
Clinical Research Coordinator Alcanza Clinical ResearchClinical Research CoordinatorRoslindale, MassachusettsScheduling subjects for study visits and conducts appointment reminders; Building/updating source as needed; Conducting monitoring visits and resolves issues as needed in a timely manner; Ensuring study related reports and patient results are reviewed by investigator in a timely manner; Filing SAE/Deviation reports to Sponsor and IRB as needed; Documenting and reporting adverse events; Reporting non-compliance to appropriate staff in timely manner; Maintaining positive and effective communication with clients and team members; Always practicing ALCOAC principles with all documentation; May assist with study recruitment, patient enrollment, and tracking as needed; Maintaining confidentiality of patients, customers and company information, and; Performing all other duties as requested or assigned. Responsibilities may include but are not limited to: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Requesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies;].
Clinical Research Budget & Effort Analyst Actalent IncClinical Research Budget & Effort AnalystBrookline, MA$36.10–$40.62 / hourWork closely with Medicare Coverage Analysts, Financial Analysts, Accounting Specialists, study teams, and the CTMS vendor to ensure data consistency across systems and to resolve budget build and effort discrepancies. Track study staff effort allocations in the CTMS or related systems to ensure effort is correctly offset to applicable clinical trial budgets, supporting accurate Workday offset entries and financial reconciliation.
GCP & GLP QA Lead Nonclinical & Clinical Quality Assurance Tango Therapeutics IncGCP & GLP QA Lead Nonclinical & Clinical Quality AssuranceBoston, MA$171,200–$256,800 / yearPartnering cross-functionally across the organization, the Director will help drive quality excellence, support regulatory inspections and submissions, and provide strategic QA guidance to internal teams and external partners. The Director, GCP & GLP QA, reporting to the Executive Director, Quality, is responsible for leading quality assurance oversight across clinical and nonclinical programs to ensure compliance with GCP, GLP, and global regulatory requirements.