Senior Clinical Operation Lead Integrated Resources, IncSenior Clinical Operation LeadCambridge, MassachusettsContractorKNOWLEDGE, SKILLS & ABILITIES: • At 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. 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.
Clinical Trials Project Manager Senior Mass General BrighamClinical Trials Project Manager SeniorMassachusettsThey will provide day to day guidance for investigators and study teams on the implementation of study protocols and will be the key liaison with the study sponsor, CRO, funding agency, central vendors, as well as all levels of study staff at the NCRI to ensure the smooth operation of assigned multi-center clinical trials. The NCRI employs physician clinical researchers, research nurse, project managers, data managers, SAS programmers, systems analysts, grants managers and administrative assistants dedicated to planning and implementing clinical trials.
Post-Doctoral Research Fellow - Laryngology AI Mass General BrighamPost-Doctoral Research Fellow - Laryngology AIBoston, Massachusetts$70,000–$71,750 / yearAdvanced programming skills in Python are required; experience with PyTorch and/or TensorFlow/Keras, OpenCV, Git, Linux/Unix environments, high-performance or cloud-based computing platforms with GPU acceleration, and reproducible research workflows is strongly preferred. Strong experience with modern machine learning methods, including deep learning, neural network architecture design, computer vision, video analysis, temporal modeling, supervised and/or self-supervised learning, and rigorous model evaluation strategies.
Clinical Trial Manager Prometrika LLCClinical Trial ManagerCambridge, MAExperience working in cross-functional teams and direct involvement in protocol and CRF development is highly valued Proven track record of ensuring GCP/regulatory/protocol compliance, managing timelines and budgets, leading risk assessments, and implementing CAPAs and KPIs SKILLS Working knowledge of the clinical drug development process Strong knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines Strong analytical and problem-solving skills Written, verbal communication and presentation skills in small and large group settings Must possess excellent interpersonal skills Mentoring/coaching Ability to effectively multi-task and prioritize Organizational skills and attention to detail required Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint Cross functional and cross-cultural awareness Ability to work in a matrix environment. RESPONSIBILITIES The Clinical Trial Manager (CTM) works closely with various sponsors, internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, study protocol, company goals, and budgets.
Post-Doctoral Research Fellow - Laryngology AI Brigham and Women's HospitalPost-Doctoral Research Fellow - Laryngology AIBoston, MA$70,000–$71,750 / yearAdvanced programming skills in Python are required; experience with PyTorch and/or TensorFlow/Keras, OpenCV, Git, Linux/Unix environments, high-performance or cloud-based computing platforms with GPU acceleration, and reproducible research workflows is strongly preferred. Strong experience with modern machine learning methods, including deep learning, neural network architecture design, computer vision, video analysis, temporal modeling, supervised and/or self-supervised learning, and rigorous model evaluation strategies.
NewClinical Contracts Manager, Cambridge, MA Isomorphic LabsClinical Contracts Manager, Cambridge, MACambridge, MAOperating at an organizational level, this role drives vendor selection, supports negotiation of Master Service Agreements (MSAs) and Clinical Trial Agreements (CTAs), and manages vendor related study budgets and contract lifecycle activities. By harnessing AI’s powerful capabilities, we can use it to model complex biological phenomena to help design novel molecules, anticipate how drugs will perform and develop innovative medicines to treat and cure some of the world’s most devastating diseases.
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.
NewRemote Medical Writer Clinical & Regulatory Sigma IncRemote Medical Writer Clinical & RegulatoryMarlborough, MARemoteThe Medical Writer will partner with Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and other stakeholders to develop accurate, scientifically sound, submission-ready documents. This role requires excellent scientific writing skills, strong knowledge of the clinical development lifecycle, attention to detail, and the ability to work independently while influencing and collaborating with cross-functional teams.
Executive Medical Director, Oncology Clinical Sciences 3316 Takeda Development Center AmericasExecutive Medical Director, Oncology Clinical SciencesBoston, MassachusettsThe actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. OBJECTIVES: The Executive Director (ED) is responsible for ensuring ongoing review and agreement of the therapy area strategy and associated documents formulated by the Oncology Therapeutic Area Unit (OTAU) prior to their review and approval by appropriate governance committees.
Clinical Development Medical Director-Nephrology Vertex Pharmaceuticals IncClinical Development Medical Director-NephrologyBoston, MA$204,000–$306,000 / yearParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate. Provides scientific and clinical input to study-related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reports.
Clinical Safety Data Manager Integrated Resources, IncClinical Safety Data ManagerCambridge, MassachusettsFull timeThe AE Intake Clinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives. Acts as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials 10%.
Clinical Data Manager Integrated Resources, IncClinical Data ManagerCambridge, MassachusettsContractorManage performance of vendors, in addition to, Data Managers and Senior Data Managers, for studies/programs run from the US, EU or Asia through the following: • Define program-level strategy for data management tasks and deliverables. • Directs the work of external vendors providing data capture technologies, data processing capabilities and data management programming capabilities to achieve quality, timely, cost-effective program/study deliverables.
Clinical Trials Safety Data Manager Integrated Resources, IncClinical Trials Safety Data ManagerCambridge, MassachusettsContractorClinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives. Acts as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials.
Clinical Study Manager Integrated Resources, IncClinical 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. 11 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.
NewClinical Regulatory Specialist Iterative Scopes IncClinical Regulatory SpecialistCambridge, MAYou will collaborate with site teams, internal stakeholders, sponsors, CROs, IRBs, and other external partners to ensure regulatory requirements are completed accurately, efficiently, and in accordance with applicable guidelines and study requirements. Working under the direction of a Clinical Regulatory Manager Director, you will partner closely with clinical research sites to manage regulatory activities throughout the study lifecycle-from study start-up and activation through ongoing maintenance and closeout.
Associate Director, Clinical Scientist Zenas BioPharmaAssociate Director, Clinical ScientistWaltham, MA$161,700–$202,200 / yearThis position works closely with Medical Directors to support medical monitoring activities, while partnering cross-functionally with Clinical Operations, Data Management, Biostatistics, Translational Sciences, Medical Affairs, and Regulatory Affairs to translate clinical strategy into operational deliverables and ensure rigorous ongoing review of trial data for quality, safety, and protocol compliance. Zenas' 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.
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.
Clinical Data Specialist Iterative HealthClinical Data SpecialistCambridge, MAThis position is responsible for conducting detailed EHR reviews to identify potential clinical trial candidates, supporting patient recruitment efforts, maintaining research databases, and ensuring accurate documentation throughout the patient pre-screening process. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need.
Clinical Trial Manager - East Coast Heartflow IncClinical Trial Manager - East CoastBoston, MARemote$95,000–$125,000 / yearHeartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMapAnalysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart.