Lead Clinical Data Manager Karwell TechnologiesLead Clinical Data ManagerCambridge, MACollaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals. Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements.
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.
Sr. Manager/Associate Director, Clinical Monitoring Oversight Aura Biosciences Inc.Sr. Manager/Associate Director, Clinical Monitoring OversightBoston, MA$150,000–$215,000 / yearThis role is responsible for the strategic oversight of Clinical Research Associates (CRAs) and/or monitoring vendors (CROs), driving site performance, data quality, patient safety, and inspection readiness across all regions in which the trial(s) are conducted. Minimum 7-10 years of clinical research experience, including significant on-site or remote monitoring experience (CRA/Senior CRA background strongly preferred); typically, 3+ years in a lead CRA, monitoring management, or comparable oversight role for AD-level.
Site Relationship Manager Integrated Resources, IncSite Relationship ManagerCambridge, MassachusettsContractorAssures ongoing site compliance with the protocols, informed consent process and documentation, as well as applicable FDA regulations and/or ICH GCP Guidelines and other local regulations critically reviews and analyses site activities and study conduct through on-site and remote assessments/contacts. Location: Cambridge, MA Duration: 12+ months (possibility of extension) JOB ROLE: · The Site Relationship Manager (SRM) within Value Based Medicine (VBM) will be responsible for the overall US site management, training and quality oversight of assigned studies.
Per Diem Family Nurse Practitioner Or Physician Assistant (Casual Employee) One MedicalPer Diem Family Nurse Practitioner Or Physician Assistant (Casual Employee)Boston, MAOur seamless in-office and 24/7 virtual care services, on-site labs, and programs for preventive care, chronic care management, common illnesses and mental health concerns have been delighting people for the past fifteen years. All regular team members working 24+ hours per week and their dependents are eligible for benefits starting on the team member's date of hire: Taking care of you today.
Per Diem Family Nurse Practitioner or Physician Assistant (Casual Employee) One MedicalPer Diem Family Nurse Practitioner or Physician Assistant (Casual Employee)Boston, MAOur seamless in-office and 24/7 virtual care services, on-site labs, and programs for preventive care, chronic care management, common illnesses and mental health concerns have been delighting people for the past fifteen years. Employee Assistance Program- Free confidential services for team members who need help with stress, anxiety, financial planning, and legal issues.
Per Diem Nurse Practitioner Or Physician Assistant (Casual Employee) One MedicalPer Diem Nurse Practitioner Or Physician Assistant (Casual Employee)Boston, MAOur seamless in-office and 24/7 virtual care services, on-site labs, and programs for preventive care, chronic care management, common illnesses and mental health concerns have been delighting people for the past fifteen years. All regular team members working 24+ hours per week and their dependents are eligible for benefits starting on the team member's date of hire: Taking care of you today.
Director, Clinical Operations WhoopDirector, Clinical OperationsBoston, MassachusettsLead 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 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.
Lead Clinical Data Manager. Integrated Resources, IncLead Clinical Data Manager.Lexington, MassachusettsFull timeBuilding Authentic Relationships: Building trusting relationships that will enhance current and future needs Leads in developing trust through transparency in communication and individual actions; ensures outcomes are team driven rather than individually driven; promotes collaborative team and organizational success Key Skills, Abilities, and. Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results.
Clinical Data and Analytics Lead Integrated Resources, IncClinical Data and Analytics LeadCambridge, MassachusettsFull time5+ years relevant work experience with a focus on data management • Deep understanding of drug development and biopharmaceutical industry required • Strong project management skills, and ability to effectively lead and collaborate with various business functions • High attention to detail including proven ability to manage multiple competing priorities • Experience overseeing outsourced clinical trials work performed by vendors • Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at vendor • Deep knowledge of clinical data management with full-service global CROs and FSPs • Demonstrated ability to influence without authority • Excellent written and oral communication skill. Liaises directly with internal customers (Medical functions, Statistical Programming, Clinical Operations, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel).
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.
Clinical Study Design Manager Science 37Clinical Study Design ManagerBoston, MAThe following qualifications are preferred and/or equivalent applicable experience: Required: 3+ years of experience in clinical research or life science industry, including at least 3 years in design of CRF/ePRO or other clinical trials database capture software. The Clinical Study Design Manager is responsible for working with our clients and internal staff to define the eSource platform specification design for the study, including all data capture requirements, bridging the gap between protocol requirements and implementation.
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.
Clinical Office Coordinator Adams ClinicalClinical Office CoordinatorWatertown, Massachusetts$22–$25.10 / hourServe as a primary point of contact for site communications, including front desk management, managing the main office phone line, triaging and routing voicemails, and internal updates to administrative and research teams. Demonstrate a strong sense of urgency in maintaining the safety of staff and participants by recognizing and responding appropriately to behavioral or safety concerns as the first point of contact, using de-escalation techniques in alignment with site protocols as needed.
Clinical Information Analyst Integrated Resources, IncClinical Information AnalystLexington, MassachusettsContractorThe role will work closely with Subject Matter Experts to define requirements, analyze and compare multiple systems for usability, strategize and implement data migration from legacy systems to new systems. This role will be involved in the implementation of new solutions, testing, management, and administration of new and legacy Client clinical systems.
Clinical Project Manager Integrated Resources, IncClinical Project ManagerLexington, MassachusettsContractorJob Position: Clinical Project Manager Location: Lexington, MA Duration: 6 Months+ (Temp to Perm) Summary: The Clinical Project Manager is responsible for independently managing a small number of studies of basic to moderate complexity or defined activities in more complex, multicenter studies (e.g., managing niche vendors). Our methods include applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective.
Clinical Supply Associate Integrated Resources, IncClinical Supply AssociateLexington, MassachusettsFull timeManage clinical supply activities including labeling, packaging, distribution of clinical trial supplies, randomization, development and maintenance of clinical trial database and drug accountability systems control. Participate in protocol review to identify clinical issues; establish time frames; develop budget projections; identify procedural and administrative issues; recommend amendments to study protocols as appropriate.
Clinical Documentation Specialist Integrated Resources, IncClinical Documentation SpecialistLexington, MassachusettsFull timeJOB REQUIREMENTS: • Processing, filing and tracking of Trial Master File (TMF) documents (paper and/or electronic) in accordance with study-specific TMF Roadmaps. JOB SUMMARY: • Manages the Trial Master Files (all of the documents that support the clinical trials-everything that the FDA and regulatory agencies review).
Contract Clinical Operations Lead Integrated Resources, IncContract Clinical Operations LeadCambridge, MassachusettsContractorRequired skill sets to include: proficiency in Microsoft Excel and Word, basic understanding and skills in legal contracts, organizational skills, effective communicator and adept at learning new systems. This person will directly assist with small value contract execution as required and will need to engage and collaborate with the business to understand business needs and expectations in order to accurately set up contracts and establish fair market value pricing.