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.
Purchases/Sourcing Specialist Integrated Resources, IncPurchases/Sourcing SpecialistRaynham, MassachusettsContractorThe Strategic Sourcing Specialist will assist with finished goods and process selection for purchases, assist in locating and selecting suppliers for purchases per category strategies, negotiate prices, develop and administer contracts for assigned suppliers, develop suppliers, develop and improve large spend category strategies and major business processes such as business continuity and supplier selection to deliver annual improvements in total cost, quality and service, and support sites as needed. The Strategic Sourcing Specialist will support category development, sourcing of finished goods and supplier relationship management for assigned areas of responsibility.
Medical Writing Science Manager Marchon PartnersMedical Writing Science ManagerBoston, MAKey Duties and Responsibilities Authors moderately complex clinical regulatory documents, including clinical study protocols, clinical study reports, investigator’s brochures, and sections of regulatory submissions, in partnership with key cross-functional stakeholders. Advanced computer skills related to word processing, templates, table and figure creation, literature searches, electronic review systems, and document management systems; ability to serve as a resource for others using these tools.
Data Management Vendor Manager Associate Integrated Resources, IncData Management Vendor Manager AssociateCambridge, MassachusettsContractorThe Data Management (DM) Vendor Manager Associate is responsible for supporting functional service provider and full-service relationships and performing tasks such as the development of outsourcing budgets, coordination of vendor governance activities with the oversight of experienced DM Vendor Managers. 5+ years in the Vendor Management field (DM and/or BIOS experience is a plus), previous work with full service CROs (and full service contracts) is required; working in a global/cross cultural setting is preferred.
Sr Manager, Early Planning & Patient Recruitment Integrated Resources, IncSr Manager, Early Planning & Patient RecruitmentCambridge, MassachusettsContractorIntegrate EPR efforts with Client Advocacy to identify Patient Advocacy Groups who can provide patient/caregiver input/perspective on study design and study burden; develop methods to assess patient and site burden of schedule of assessments e.g., duration of visits, frequency of visits compared to SOC, questionnaire volume / survey fatigue, etc. · Identify & manage vendor(s) and develop process to support study teams regarding the assessment and incorporation of patient input into Client protocols to influence study design and early operational strategy with the goal of generating data to support executable, patient-friendly study designs and assessments.
Medical Writer Integrated Resources, IncMedical WriterMassachusettsContractorPosition Title: Medical Writing Specialist Division: Strategic Medical Affairs Reports To: Medical Safety Project Manager Job Function Summary The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the DePuy Synthes Strategic Medical Affairs Team for a wide range of audiences. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
Global Senior Medical Program Manager LancesoftGlobal Senior Medical Program ManagerCambridge, MA$98This will include leadership of MSTs and/or other program teams, in strategic direction and translating program strategy into an efficiently executable plan;predicting and planning solutions to achieve successful operational execution;driving the team to achieve forecast accuracy and effective risk management. You will also partner closely with the Global Medical Unit Head (GMUH) and medical cross- functional teams, as well as relevant global, regional and local Medical Affairs, Commercial and R&D functions, as required, to ensure that the medical and functional strategy is integrated into operational plans and systems.
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.
Laboratory Sample Project Manager Varite, IncLaboratory Sample Project ManagerWaltham, MA$35–$38 / hourResponsibilities (Client Service Administrator I): Provide administrative and customer-facing support for Analysis Service projects, acting as a key contact between customers, sales teams, laboratories, and internal stakeholders, Coordinate project documentation, including service agreements, sample forms, manifests, and customer communications, ensuring accurate and timely processing. Key Skills: Customer Service, Project Administration, Sample Logistics Coordination, Salesforce CRM, RMT+, Outlook, Kanban, Microsoft Office, Documentation Management, Stakeholder Communication, Process Coordination, Cross-functional collaboration.
Senior Clinical Trial Manager TScan TherapeuticsSenior Clinical Trial ManagerWaltham, MA$170,000–$187,000 / yearThe submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics’ internal Talent Acquisition team. Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism.
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.
Lead Clinical Data Manager Integrated Resources, IncLead Clinical Data ManagerLexington, MassachusettsContractorTakes 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 Courage to challenge. · Partnering with customers as a trusted consultant and becoming an integral part of customer's decision making Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines.
Clinical Site Relationship Manager Integrated Resources, IncClinical Site 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 analyzes site activities and study conduct through on-site and remote assessments/contacts. Responsible for development of study monitoring and management documentation and tools as delegated by the sponsor, including: Clinical Monitoring Plan, SIV slides, Regulatory Binder, Study Reference Guide, site tools, etc.
Lead Clinical Data Manager Katalyst Healthcares & Life SciencesLead Clinical Data ManagerBoston, 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.
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 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 Research Associate (CRA) – Temporary 6 Month Contract Lighthouse Lab ServicesClinical Research Associate (CRA) – Temporary 6 Month ContractWaltham, MAThe CRA will serve as a primary point of contact for assigned clinical partners and investigator sites, supporting study enrollment, monitoring, data quality, protocol compliance, and study close-out activities. Track and submit required reports, documentation, updates, and metrics, including protocol deviations, patient recruitment, clinical supplies, and overall study progress.
Senior Manager- Knowledge Management for Clinical Affairs Integrated Resources, IncSenior Manager- Knowledge Management for Clinical AffairsCambridge, MassachusettsContractorResponsibilities: Gathering end user requirements from key stakeholders and review of technical specifications for information governance in partnership with IT, maintaining of critical functionality of the CRM platform to ensure uninterrupted access by HCPs to company product information; Creation and maintenance of all metrics and analytic tools necessary for supporting GMA decision making and maintenance of the content management system used by Worldwide Medical. Advanced computer skills and experience in Sales force, web based inquiry database like Service Cloud, Veeva products like Vault, Tableau, Microsoft Office Suite software, and Endnotes software.
Research Scientist LancesoftResearch ScientistCambridge, MA$33The role is a highly technical and/or specialized professional position responsible for supporting several disease areas across Client Biomedical Research (Cambridge, MA USA) providing high quality & consistent in vivo technical research support within our multi-building, multi-discipline research program. Our Global Genetically Engineered Models (GEMs) Team within Comparative Medicine (CM) supports the expansion of animal science, preclinical care, and research model development furthering research across the world.
Senior Clinical Study Manager Integrated Resources, IncSenior Clinical 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. In collaboration with Study Execution Team (Takeda functions, Strategic Partners, and vendors), 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.