Senior Manager, Clinical Scientist Vor BioPharma IncSenior Manager, Clinical ScientistBoston, MA$160,000–$175,000 / yearContributes to preparation and/or review of any documents related to the studies and requiring a scientific background (abbreviated protocol/protocol/amended protocol, informed consent form, presentations/communication to internal or external partners, study plans including medical monitoring plan, safety management plan, risk mitigation plan and recruitment materials). Contributes to definition of the centralized monitoring strategy in consistency with the planned statistical analysis and is involved in study data validation and review processes, support the Head of PV for Clinical Case review (all safety events), notably to anticipate and prevent last minute queries or backlog and smoothen the process.
Contracts Assistant Clinical Vendor Management Integrated Resources, IncContracts Assistant Clinical Vendor ManagementCambridge, MassachusettsFull timeDecision Making, Discretion & Latitude•Responsible for ensuring prompt and efficient receipt, signature, delivery, tracking, uploading and archival of all clinical contracts within the CVM group•Follows up on PO process from requisitions through to PO approval•Identifies areas for administrative process improvement and provides suggestionsWith Direction•Initiates purchase order requisitions upon receipt of supporting documentation as needed•May support Vendor Contract Manager in researching contract history and next available appendix informationKnowledge & SkillsMust have excellent communication skills, the ability to work efficiently and to perform tasks simultaneously with minimum supervision in a fast paced environment, exceptional organizational skills with a demonstrated ability to work in an accurate manner, great attention to detail, the ability to exercise sound judgment and determine priorities, the ability to work as part of a dynamic team, the ability to execute activities under tight timelines and high stress situations,proficiency with computers including MS Office suite with emphasis on Excel and Word, and the ability to quickly learn new technologies and processes. Job DescriptionPosition Details:Client Direct ClientLocation Lexington, MAJob Title Contracts Assistant Clinical Vendor ManagementDuration 7+ MonthsMust have skill-set [Job Description] Job SummaryTo work as an integral part of the Clinical Vendor Management (CVM) team providing proactive, high quality contracts administrative support to the global Vendor Contracts Managers (VCMs) in collaboration with the Contracts Associates.
Admin Contracts Assistant-Clinical Vendor Management Integrated Resources, IncAdmin Contracts Assistant-Clinical Vendor ManagementCambridge, MassachusettsContractorIndependent•Responsible for ensuring prompt and efficient receipt, signature, delivery, tracking, uploading and archival of all clinical contracts within the CVM group•Follows up on PO process from requisitions through to PO approval•Identifies areas for administrative process improvement and provides suggestionsWith Direction•Initiates purchase order requisitions upon receipt of supporting documentation as needed•May support Vendor Contract Manager in researching contract history and next available appendix informationMust have excellent communication skills, the ability to work efficiently and to perform tasks simultaneously with minimum supervision in a fast paced environment, exceptional organizational skills with a demonstrated ability to work in an accurate manner, great attention to detail, the ability to exercise sound judgment and determine priorities, the ability to work as part of a dynamic team, the ability to execute activities under tight timelines and high stress situations,proficiency with computers including MS Office suite with emphasis on Excel and Word, and the ability to quickly learn new technologies and processes. This may include collaborating with the Contracts Associate in providing oversight of CROs/FSPs who are contracted to upload contracts on our behalf to ensure commitments are met 20%•Data Cleanup and Migration: Collaborate with Contract Associates and Outsourcing Associate in the review and cleanup and migration of contract data in teams contract organizational tool and legal contract storage system.
Manager Clinical Data Monte Rosa Therapeutics, IncManager Clinical DataBoston, MassachusettsFull timeThis 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.
NewClinical Research Coordinator - Dana-Farber Cancer Institute at South Shore Hospital South Shore HealthClinical Research Coordinator - Dana-Farber Cancer Institute at South Shore HospitalWeymouth, MAThe Clinical Research Coordinator (CRC) will support the clinical research program and research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. Participates in continued learning and possess a willingness and ability to learn and utilize new technology and procedures that continue to develop in their role and throughout the organization.
NewClinical Research Coordinator - Dana-Farber Cancer Institute At South Shore Hospital South Shore HealthClinical Research Coordinator - Dana-Farber Cancer Institute At South Shore HospitalWeymouth, MA$23.89–$32.15 / hourThe Clinical Research Coordinator (CRC) will support the clinical research program and research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. Participates in continued learning and possess a willingness and ability to learn and utilize new technology and procedures that continue to develop in their role and throughout the organization.
Director of Clinical Quality Integrated Resources, IncDirector of Clinical QualityCambridge, MassachusettsContractorPerson must be able to coordinate other QA contractors for auditsMust also be able to deliver SOP's and processes andThis is ONLY in the GCP area Must have GCP experience Must have Pharma Experience within Quality Assurance Coordinating audits (internal, external) Inspection experience (FDA) Need to have worked in a development program so they know how to coordinate audits for a development programJob Description:Job Title: Director, Vaccines Clinical Compound Support Quality Assurance OBJECTIVES: • Plays a leadership role in ensuring that investigator, vendor, facility and system audits are conducted, for communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented. EXPERIENCE, KNOWLEDGE AND SKILLS: Knowledge and Skills: In-depth knowledge of the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidances and Computer System Validation • Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
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;].
NewClinical Study Operations Manager Beacon BiosignalsClinical Study Operations ManagerBoston, MassachusettsRemote$90,000–$110,000 / yearAs such, we're always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. As a Clinical Study Operations Manager within the Clinical Study Operations team, you will be responsible for ensuring the successful operational delivery of Beacon’s clinical studies, from startup through close-out.
Clinical Research Associate II AbbVie IncClinical Research Associate IIBoston, MAApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role atthe time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to aparticular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion,consistent with applicable law.
Clinical Research Coordinator - Brighton Dana-Farber Cancer Institute IncClinical Research Coordinator - BrightonMA$48,100–$54,400 / yearThe Clinical Research Coordinator will work within the Brighton Dana-Farber Satellite clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DFCI disease programs. Responsible for data reporting and management, collection of source documents, use of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries for all studies at the Satellite site(s).
Clinical Research Coordinator CareerscapeClinical Research CoordinatorBoston, MA$50,000–$65,000 / yearTemporaryThe Clinical Research Coordinator will manage the day-to-day operational requirements of assigned studies, including patient enrollment, protocol adherence, data collection, and regulatory documentation. The position requires direct interaction with study participants, sponsor representatives, and institutional review boards, and demands a working knowledge of FDA regulations and Good Clinical Practice guidelines.
Senior clinical Project manger Integrated Resources, IncSenior clinical Project mangerLexington, MassachusettsContractorThey work closely with the Program Manager supporting the person responsible for overall team leadership to ensure robust and balanced cross-functional planning, decision-making, implementation, monitoring, and reporting of the E/GDT(s) for multiple related programs to ensure strong alignment between Product, Lifecycle strategy (if applicable) and operational execution by the E/GDTs.• Job DescriptionLocation: Lexington, MAPosition- Senior Clinical Project ManagerJob Summary:• The candidate will be responsible for supporting the operational, planning, and decision-making processes within Client’s Early / Global Development Teams (E/GDT).•
Clinical Operations Lead Integrated Resources, IncClinical Operations LeadCambridge, MassachusettsContractorSecures operational excellence and delivery for one or more clinical studies by:Developing operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country LeadOverseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRODriving performance, quality, timelines and relationships through the CRO partnership modelChairs 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 issuesPartnering with GCO Vendor Management to escalate issues, sharing best practices and leveraging the relevant vendor management member for issue resolution3. Strives for effective, consistent, efficient and compliant processes by:Championing best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management groupSeeks interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phaseFollows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing modelEmbodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership modelAt 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.
Associate Director, Clinical Supplies Project Manager ModernaTXAssociate Director, Clinical Supplies Project ManagerCambridge, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. The scope includes the operational planning and strategy required to execute end-to-end supply management, including demand planning, label development, packaging/labeling, distribution, IRT UAT/supply management, temperature excursions, and site activations.
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.
Senior Scientist, Clinical Research Merck & Co IncSenior Scientist, Clinical ResearchBoston, MA$117,000–$184,200 / yearCo-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. Experience managing Immunology and/or vaccine trials with an ability to think outside of the box, explore novel ways of working and comfortably navigate ambiguity to drive results also a plus.
Senior Clinical Document Management Specialist Integrated Resources, IncSenior Clinical Document Management SpecialistLexington, MassachusettsContractorPharmaceutical experience- doesn't necessarily need to be exclusive to TMF/ CDM experience- must haveDirect experience (in-depth) with TMF related roles- must haveClinical Document Management experienceExperience with clinical trial can be consideredCan consider candidates with lots of years of experience in a clinical setting as long as they have in-depth TMF experienceExperience working with electronic TMF- nice to haveMinimum 5 years of pharmaceutical industry experience related to clinical document managementFamiliarity with various aspects of clinical trials and regulatory submissions, as well as strong knowledge of document management best practices. DUTIES/RESPONSIBILITIES:Managing studies from start-up to close outWorking with CRO's for a large number of studiesEntire lifecycle management of TMFResolving findings and communicating it to the right peopleSenior staffs mentor the regular CDM staff and oversees day-to-day processesInvolved in internal audits and external inspectionsMake sure that they know the location of all the documentsArchive Corporation of documentsQUALIFICATIONS:Someone with management/mentoring responsibility in the past- a very strong nice to haveMin.
Regional Clinical Trial Manager - East Coast, US PrileniaRegional Clinical Trial Manager - East Coast, USBoston, MassachusettsRemoteThis is a critical individual contributor role in a growing biotech company, suitable for a candidate who is equally comfortable working independently across multiple projects and while collaborating in a matrix global team environment. Ability to work across multiple projects with demonstrated ability to manage CROs (and other vendors) to meet or exceed KPIs tied to corporate goals and hold them accountable if they fall behind.
Clinical Research Coordinator I OraClinical Research Coordinator IWarwick, Rhode IslandPerform various tasks (post-onboarding) such as use of proprietary technology, performing the Informed Consent process, documenting medical history and medications, taking vitals, scribing for medical staff, dispensing study drug, performing allergy skin tests, documenting controlled environment stats, and other ophthalmic assessments. Our CRC I’s will partner with tenured Clinical Research Coordinators and Clinical Project Managers to execute protocol directives and work cross-functionally with internal and external teams such as other Research Coordinators and Investigators.