Clinical Project Manager III Integrated Resources, IncClinical Project Manager IIILexington, MassachusettsFull timeLeads cross-functional team and is responsible for the financial management of the study (ies).Responsibilities % of Time Job Function and Description 10 %: Represents and leads the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline Authors/contributes to clinical study documents. Key Skills, Abilities, and Competencies Strong knowledge of applicable computer and project management software packages, including Microsoft Word, Excel, Project, and Power Point Familiarity with financial budgeting and forecasting or reporting Requires strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
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.9. 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.12.
Senior Clinical Operation Lead Integrated Resources, IncSenior Clinical Operation LeadCambridge, MassachusettsContractorDevelop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plansLeverage appropriate on going data review to identify and mitigate patient, study design, data or study conduct issuesEnsure all operational aspects support end point integrity and data validity. Job DescriptionPosition Details:Client Direct ClientLocation Cambridge, MAJob Title Senior Clinical Operation LeadDuration 1year+ (possible extension)Must have skill-set JOB RESPONSIBILITIES:Partners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols.
Clinical Research Associate Integrated Resources, IncClinical Research AssociateLexington, MassachusettsFull timeJob DescriptionThe in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the Clinical Project Manager(s).The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager. Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.Reviews Clinical Monitoring Reports and correspondence related to restudy and Initiation Visits and follows up with Clinical CRO to resolve open action items.
Sr.Clinical Operations Lead Integrated Resources, IncSr.Clinical Operations LeadCambridge, MassachusettsFull timePartnering with GCO Vendor Management to escalate issues, sharing best practices and leveraging the Vendor Operations Relationship Manager for issue resolution• Initiates, leads and shares best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group• Identifies interdependencies and synergies with other trials and programs and seeks to proactively put into place process or forum to enhance excellence in planning and execution across all studies in a phase• Follows 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)• Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model• Is an advocate for the COL group and a visible contributor and vehicle to promote interaction• Is an influential leader and a resource for COLs within the Clinical Operations Management group.• Initiates and leads discussions at peer level forums relevant to the COL role and development in line with GCO best practices.• Able to influence MD on clinical study/program direction based on changing internal and external landscapes within phase, disease or therapeutic area; able to think strategically to best position a study within the current Clinical Development Plan.• Chairs SMT meetings and drives effective and efficient team operations through communication, goal setting and strategy implementation• 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• Develops and leverages Phase expertise (e.g.
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.
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.
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.
NewClinical Research Coordinator II Mass General BrighamClinical Research Coordinator IIBoston, MassachusettsFollowing established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, EEGs, etc. The Massachusetts General Hospital Department of Emergency Medicine's division of clinical research is seeking a highly motivated individual with a minimum of one year hands-on clinical research experience to assist with ongoing and future clinical research studies as Clinical Research Coordinator II.
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.
Senior Clinical Research Coordinator Beth Israel Lahey HealthSenior Clinical Research CoordinatorBoston, Massachusetts$24.04–$36.06 / hourThis position is embedded within the BIDMC Clinical Research Coordinator Core, a centralized resource serving investigators across departments and divisions throughout the medical center, and operating in affiliation with the institution's Clinical Research Center, a member of Harvard Catalyst — Harvard's Clinical and Translational Science Center. Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving.
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.
Clinical Research Associate Alira HealthClinical Research AssociateBoston, MA$85,000–$125,000 / yearThe CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality.
Clinical Research Associate CRA Alira HealthClinical Research Associate CRABoston, MAThe CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality.
Clinical Research Nurse, Pediatrics Boston Medical CenterClinical Research Nurse, PediatricsBoston, MA$34.38–$50 / hourKey responsibilities include maintaining a leadership role in the prenatal, pediatric HIV and research activities of the section of pediatric infectious diseases integrating clinical care, patient education and access to research protocols appropriate for the BMC population. The major responsibilities of this position will be maintaining a leadership role in the prenatal, pediatric HIV and research activities of the section of pediatric infectious diseases integrating clinical care, patient education and access to research protocols appropriate for the BMC population.
Clinical Data and Analytics Lead Integrated Resources, IncClinical Data and Analytics LeadCambridge, MassachusettsFull timeQualifications• 5+ 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 Primary contact between Data Management and clinical study management teams (SMT and/or Clinical Development Team representatives).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).Serves as Subject Matter Expert for data, reporting, and analysis process definition, improvement, and innovation as needed.