Director, Radiation Oncology Operations Tufts MedicineDirector, Radiation Oncology OperationsStoneham, MA$162,773.52–$207,541.52 / yearDrive updates to radiation oncology model to ensure high-quality, safe patient care and efficient workflows across radiation oncology department, across four sites of care including both AMC and community settings. Will oversee operations at four radiation oncology sites for the Tufts Medicine system: Tufts Medical Center/Boston, Tufts Medical Center /Framingham, Melrose-Wakefield Hospital/Stoneham, and Lowell General Hospital/Lowell.
Sr. Manager, Clinical Quality Assurance Summit Therapeutics IncSr. Manager, Clinical Quality AssuranceCambridge, MA$158,000–$185,000 / 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. In collaboration with the Global RD/PV QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections.
Senior Manager Clinical Compliance Actalent IncSenior Manager Clinical ComplianceBrighton, MARemote$84–$89 / hourThis role oversees Trial Master File (TMF) inspection readiness, drives corrective and preventive action (CAPA) and continuous improvement activities, and partners closely with cross-functional teams and external vendors to maintain a robust GCP-compliant quality framework. The position offers the opportunity to spearhead clinical compliance for a growing biotechnology organization, support an exciting pipeline across multiple clinical trial phases, and work directly with executive leadership in a long-term, strategic capacity.
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 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.
Clinical Trial Manager Actalent IncClinical Trial ManagerWaltham, MARemote$80–$90 / hourThe CTM will supervise all aspects of Clinical Trial Operations, including project management, study center activities oversight, CRA monitoring activities, and vendor management, ensuring that trials are delivered on time, with high quality, and within budget. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
Clinical Nursing Manager- Acute Care Transition Team Tufts MedicineClinical Nursing Manager- Acute Care Transition TeamLowell, MA$134,525.66–$171,524.44 / yearResponsibilities that typically include: Setting goals and objectives for team members for achievement of operational results, problems faced may be difficult but typically are not complex, and ensures policies, practices and procedures are understood and followed by direct reports, customers and stakeholders. As a member of this specialized team, you will provide expert inpatient nursing care, partnering with multidisciplinary teams to ensure safe, seamless, and compassionate transitions throughout the patient's journey.
Clinical Nurse Manager- Labor And Delivery Tufts MedicineClinical Nurse Manager- Labor And DeliveryLowell, MA$134,525.66–$171,524.44 / yearIndividual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals. Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth-one of the many ways we invest in you so you can thrive both at work and outside of it.
Senior Clinical Data Manager Tango TherapeuticsSenior Clinical Data ManagerBoston, MAEnsure timely delivery of complete, accurate, reliable, and inspection-ready clinical data through effective oversight of outsourced Data Management activities, including EDC, IRT and eCOA system build, validation and maintenance, data collection, data cleaning, medical coding, external data integration and reconciliation, database/system lock, and submission readiness. Review and approve key Data Management deliverables, including CRF/eCRF, IRT, eCOA specifications, edit checks, Data Management Plans, CRF completion guidelines, data transfer specifications, external data reconciliation plans, and other study-specific documentation.
Senior Clinical Trial Manager (Contract) Centessa Pharmaceuticals PlcSenior Clinical Trial Manager (Contract)Boston, MA$70–$100 / hourCentessa 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. This role is a temporary position with the potential to convert to a permanent role, accountable for study delivery, including operational strategy, timelines, budget, quality, vendor oversight, risk management, and inspection readiness.
Head of Clinical Process and Standards Galderma Group AGHead of Clinical Process and StandardsBoston, MA$200,000–$265,000 / yearWhere pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.
Sr. Scientist/Principal Scientist, Translational Research and Clinical Biomarkers (Immunology) Antares TherapeuticsSr. Scientist/Principal Scientist, Translational Research and Clinical Biomarkers (Immunology)Boston, MassachusettsCollaborate with teams across the organization, including clinical operations and data management, to ensure biomarker assay implementation and execution, and aid in the management of biomarker samples and data. The actual salary offered will be based on a number of factors, including but not limited to the qualifications of the applicant, years of relevant experience, level of education attained, certifications or other professional licenses held, and if applicable, the location in which the applicant lives and/or from which they will be performing the job.
Senior Clinical Trial Manager Summit Therapeutics IncSenior Clinical Trial ManagerCambridge, MA$158,000–$185,000 / 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 approves study-related plans, processes, and documents including Informed Consent Forms, Investigator Agreements (CTA), CRFs, CRF Guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management plans, and safety monitoring activities.
Medical Director, Clinical Development Dyne TherapeuticsMedical Director, Clinical DevelopmentWaltham, MA$270,000–$310,000 / yearThis role serves as the medical monitor on their assigned study(s), partnering closely with Clinical Development leadership, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biostatistics, Data Management, Translational Medicine, and other key stakeholders to support study design, protocol execution, medical review, data analysis, and regulatory deliverables. This role is responsible for ensuring participant safety, supporting high-quality study execution, interpreting emerging clinical and safety data, and providing timely medical input to study teams, investigators, vendors, and cross-functional partners.
NewAssociate Director, Study Operation Manager - Nonclinical Toxicology Centessa Pharmaceuticals PlcAssociate Director, Study Operation Manager - Nonclinical ToxicologyBoston, MA$150,000–$220,000 / yearCentessa Pharmaceuticals is seeking an experienced Associate Director, Study Operations - Nonclinical Toxicology to manage and oversee day-to-day operations for toxicology and safety pharmacology studies conducted in the selected CROs to include study forecasting, budgeting, planning, data management, quality assurance, compliance, communications and collaboration with different functional teams across the portfolio of Orexin agonist programs. 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.
Global Managed Access Manager LancesoftGlobal Managed Access ManagerWaltham, MA$1Job Description: Work with internal stakeholders to provide operational leadership for CLIENT oncology expanded access/compassionate programs including plans and strategies for footprint, drug supply, regulatory coordination, physician oversight, vendor set up and management, safety reporting, and other related activities accordance with CLIENT Policies and SOPs. Establish strong relationships with all stakeholders, including Global Medical Affairs colleagues, Supply team, LOCs, physicians, program managers, regulatory and safety teams as well as external vendors.
Senior Manager, Regulatory Affairs Avalyn PharmaSenior Manager, Regulatory AffairsBoston, MassachusettsA minimum of 5-8 plus years of regulatory affairs experience within the pharmaceutical, biotechnology, or combination product industry, with operational support of global clinical trials, and direct authorship of regulatory submissions for investigational and commercial products. AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone.
Medical Director Actalent IncMedical DirectorWaltham, MA$175–$225 / hourThe role involves close partnership with teams such as safety, clinical operations, data management, programming, biostatistics, medical writing, and regulatory affairs, as well as regular interaction with Sr leadership. The Medical Director works cross-functionally with internal teams and external partners to ensure high-quality trial execution, regulatory compliance, and effective communication of clinical results.