Clinical Trial Manager IconmaClinical Trial ManagerBoston, MA$26.16–$28.34 / hourAdvise RSP policy owner/committee chair on policy style, writing, programming; collaboration with subject matter experts; alignment of policy directives, procedural job aids, and committee direction. Identify available resources, including needed mentoring, partnerships, for example, SRG, scientific writing core, CCRO, biostats core, IRB, budget development].
Clinical Research Nurse II, Oncology IconmaClinical Research Nurse II, OncologyBoston, MA$70.02–$72.19 / hourCoordinates with clinical research coordinators and collaborates with staff within respective disease groups and with outside organizations in the completion of clinical research trials. Position requires tact and diplomacy to successfully motivate/educate subjects and staff, and knowledge of research regulations and research compliance requirements, including Protection of Human Subjects.
Medical Director, Sickle Cell Disease, Clinical Development Agios PharmaceuticalsMedical Director, Sickle Cell Disease, Clinical DevelopmentBoston, MA$221,600–$369,333 / yearThe current base salary range for this position is expected to be between $221,600 and $369,333 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
Senior Manager, Clinical Educator, Sickle Cell Disease - Remote Agios PharmaceuticalsSenior Manager, Clinical Educator, Sickle Cell Disease - RemoteBoston, MARemote$131,035–$196,553 / yearThe current base salary range for this position is expected to be between $131,035 and $196,553 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The ACE will also gain insights from clinical teams and office staff supporting patients with sickle cell disease to further their understanding of the disease burden associated with sickle cell disease and the types of support they need for their patients.
Senior Manager, Clinical Nurse Educator – Sickle Cell Disease - Remote Agios PharmaceuticalsSenior Manager, Clinical Nurse Educator – Sickle Cell Disease - RemoteBoston, MARemote$127,219–$190,828 / yearBuilding on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives.
MDS Specialist RN Care-OneMDS Specialist RNPeabody, MA$93,000–$99,000 / yearThe MDS/Clinical Reimbursement Coordinator will be responsible for, but not limited to: Direct the Resident Assessment Process through assisting with the completion of the Minimum Data Set (MDS) and CAA's. Participate in developing individualized resident Care Plans, identifying the needs of the resident and projected outcomes as required by Federal and State regulations.
NewMDS Specialist Care-OneMDS SpecialistBrookline, MAThe MDS/Clinical Reimbursement Coordinator will be responsible for, but not limited to: Direct the Resident Assessment Process through assisting with the completion of the Minimum Data Set (MDS) and CAA's. Participate in developing individualized resident Care Plans, identifying the needs of the resident and projected outcomes as required by Federal and State regulations.
CDI Validation Specialist Compunnel, Inc.CDI Validation SpecialistBoston, Massachusetts$63 / hourTemporaryFull timeThis role ensures efficiency, accuracy, and quality of documentation, supports education and training for CDI Specialists, and collaborates with coding and validation managers to improve documentation practices that directly impact key performance indicators. Job Summary We are seeking an experienced CDI Validation Specialist (CDI Team Lead) to oversee, evaluate, and analyze Clinical Documentation Integrity (CDI) functions.
NewDirector Medical Affairs - Clinical Microbiology Waters CorporationDirector Medical Affairs - Clinical MicrobiologyAnywhere, MAThe Director is expected to bring deep diagnostic and laboratory expertise, strong business acumen, and a collaborative leadership style to advance medical credibility, innovation, and patient impact across Waters Advanced Diagnostics. This individual translates unmet customer and patient needs, evolving clinical practice, and real-world evidence into actionable medical strategies that strengthen product differentiation, support lifecycle decisions, and enable successful development and adoption of innovative diagnostic solutions.
NewSoftware Development Engineer JobotSoftware Development EngineerBoston, MA$65–$80 / hourDevelopers at this level are building greater independence, taking ownership of small to medium-sized work items, and strengthening their core engineering skills across multiple application layers, including user interfaces, services, APIs, and data. Our teams include professionals across software engineering, product development, clinical informatics, research, and healthcare technology who share a commitment to reducing complexity and improving outcomes for patients and providers.
NewNurse Care Manager Hebrew SeniorLifeNurse Care ManagerGeorgetown, MA$78,576.07–$117,864.10The Nurse Care Manager collaborates with team members to engage residents in wellness assessments and health education, connect them to needed services, support in managing health concerns, coordinate care for residents returning from hospital or rehabilitation stays, document all resident care tasks, and partner with community providers to promote overall well-being. At its core, enhanced housing with services is a proactive approach wherein resident services staff regularly and actively reach out to each individual resident to engage with them around their health and wellness, identify areas of need/risk and provide intensive, individualized case management and support as needed and desired by the resident.
NewNurse Care Manager Brookline 40 hour Hebrew SeniorLifeNurse Care Manager Brookline 40 hourBrookline, MA$86,670.93–$130,006.92The Nurse Care Manager collaborates with team members to engage residents in wellness assessments and health education, connect them to needed services, support in managing health concerns, coordinate care for residents returning from hospital or rehabilitation stays, document all resident care tasks, and partner with community providers to promote overall well-being. At its core, enhanced housing with services is a proactive approach wherein resident services staff regularly and actively reach out to each individual resident to engage with them around their health and wellness, identify areas of need/risk, and provide intensive, individualized case management and support as needed and desired by the resident.
NewClinical Research Coordinators K2 Staffing LLCClinical Research CoordinatorsFoxboro, MAPrimary Responsibilities: Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate Communicate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator Articulate all pertinent issues to the Pl or document by email/letter or during meetings Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitor(s), Auditors and any marketing groups hired by the Sponsor Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at K2 Medical Research Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging Maintain timely K2 Medical Research source documentation as well as sponsor required information. Complete all monitor and sponsor queries in a timely manner Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient's participation in study Knowledge, Skills, and Abilities: Outstanding verbal and written communication skills Excellent interpersonal and customer services skills Strong time management and organizational skills In depth knowledge of industry regulations Proven ability to and foster mentoring relationships Ability to create momentum and foster organizational change Qualifications: Bilingual in Spanish/English highly desired.
NewFull Time Nurse Care Manager Hebrew SeniorLifeFull Time Nurse Care ManagerBrockton, MA$84,971–$127,458The Nurse Care Manager works closely with other team members to: engage residents in wellness assessments and health education programs, connect residents to needed services, triage resident issues, provide a wide variety of case management tasks including coordinating care for residents returning home from hospital and/or rehab stays, ensure that all interventions are documented and tracked, and partner with community provider organizations. At its core, enhanced housing with services is a proactive approach wherein resident services staff regularly and actively reach out to each individual resident to engage with them around their health and wellness, identify areas of need/risk and provide intensive, individualized case management and support as needed and desired by the resident.
NewFull Time Nurse Care Manager (Brockton) Hebrew SeniorLifeFull Time Nurse Care Manager (Brockton)Brockton, MA$84,971–$127,458The Nurse Care Manager works closely with other team members to: engage residents in wellness assessments and health education programs, connect residents to needed services, triage resident issues, provide a wide variety of case management tasks including coordinating care for residents returning home from hospital and/or rehab stays, ensure that all interventions are documented and tracked, and partner with community provider organizations. At its core, enhanced housing with services is a proactive approach wherein resident services staff regularly and actively reach out to each individual resident to engage with them around their health and wellness, identify areas of need/risk and provide intensive, individualized case management and support as needed and desired by the resident.
NewNurse Care Manager Brockton 40 hour Hebrew SeniorLifeNurse Care Manager Brockton 40 hourBrockton, MA$84,971–$127,458The Nurse Care Manager works closely with other team members to: engage residents in wellness assessments and health education programs, connect residents to needed services, triage resident issues, provide a wide variety of case management tasks including coordinating care for residents returning home from hospital and/or rehab stays, ensure that all interventions are documented and tracked, and partner with community provider organizations. At its core, enhanced housing with services is a proactive approach wherein resident services staff regularly and actively reach out to each individual resident to engage with them around their health and wellness, identify areas of need/risk and provide intensive, individualized case management and support as needed and desired by the resident.
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.
NewClinical Research Data Specialist I Brigham and Women's HospitalClinical Research Data Specialist IBoston, MA$20.16–$29.01 / hourPrincipal Duties and Responsibilities: The CRDS I will perform the following responsibilities under general supervision by the Clinical Research Manager: Proactively track assigned research subject's upcoming protocol appointments and visits and document on central clinical research data specialist (CRDSP) tracker. General Summary/Overview Statement: The Clinical Research Data Specialist I (CRDS I) works under general supervision to extract clinical data and research data from electronic medical records and other sources and enters this data into electronic data capture system utilized for the clinical research protocol.
Clinical Data Specialist Iterative Scopes IncClinical Data SpecialistBoston, 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.
NewClinical Research Data Specialist I Mass General BrighamClinical Research Data Specialist IBoston, MassachusettsPrincipal Duties and Responsibilities: The CRDS I will perform the following responsibilities under general supervision by the Clinical Research Manager: · Proactively track assigned research subject’s upcoming protocol appointments and visits and document on central clinical research data specialist (CRDSP) tracker. General Summary/Overview Statement: The Clinical Research Data Specialist I (CRDS I) works under general supervision to extract clinical data and research data from electronic medical records and other sources and enters this data into electronic data capture system utilized for the clinical research protocol.
Research Data Specialist - Breast Oncology Clinical Trials Dana-Farber Cancer Institute IncResearch Data Specialist - Breast Oncology Clinical TrialsBOSTON, MARemote$50,500–$56,700 / yearWe strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. Develop knowledge of specialized data sources specific to outcomes data reporting, including routine reaching out to offsite providers to obtain information from medical records at outside sites of care.
Clinical Data Management Technical Specialist TandymClinical Data Management Technical SpecialistWoburn, Massachusetts, MassachusettsRemote$64 / hourIn this role, the Clinical Data Management Technical Specialist will be responsible for providing technical expertise and project management support for the Clinical Data Management team. A pharma company in Massachusetts is looking to fill an immediate remote/contract need with the addition of a new Clinical Data Management Technical Specialist to their team.
NewResearch Data Specialist - GI Oncology Clinical Trials Dana-Farber Cancer Institute IncResearch Data Specialist - GI Oncology Clinical TrialsBOSTON, MARemote$50,500–$56,700 / yearThe GI Oncology Clinical Research Program supports PI initiated, industry sponsored, and cooperative group phase I - IV clinical trials across multiple GI cancers, including esophageal, stomach, liver, pancreas, colon, and neuroendocrine. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
NewResearch Data Specialist - Immune Effector Cell Therapy Program Dana-Farber Cancer Institute IncResearch Data Specialist - Immune Effector Cell Therapy ProgramBOSTON, MARemote$50,500–$56,700 / yearWe strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. The Research Data Specialists (RDS) will support the Immune Effector Cell Therapy clinical research program in the areas of data collection, computing, and database organization.
NewResearch Data Specialist - Gastrointestinal Oncology Dana-Farber Cancer Institute IncResearch Data Specialist - Gastrointestinal OncologyBOSTON, MA$50,500–$56,700 / yearWe strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications.
NewResearch Data Specialist - Multiple Myeloma Dana-Farber Cancer Institute IncResearch Data Specialist - Multiple MyelomaBOSTON, MARemote$50,500–$56,700 / yearWe strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. Develop knowledge of specialized data sources specific to outcomes data reporting, including routine reaching out to offsite providers to obtain information from medical records at outside sites of care.
Oncology Data Specialist - 32 hours/week, day shift Lahey Hospital and Medical CenterOncology Data Specialist - 32 hours/week, day shiftBeverly, MA$27–$36.34 / hourThe Oncology Data Specialist also may assist with the accreditation process activities for the American College of Surgeons Cancer CoC program, NAPRC, and NAPBC; quality improvement activities, cancer conferences, and community and professional education programs; and provides ongoing communications with the State Health Registries. 2) Analyzes, abstracts, and codes selected cases utilizing a variety of manuals, including but not limited to: ICD - 03, STORE, SEER, AJCC Staging, Grade, EOD, Solid Tumor Rules, Hematopoetic Manuals, and the Mass Cancer Registry.
Senior Clinical Research Finance Specialist Iterative HealthSenior Clinical Research Finance SpecialistCambridge, MA$85,000–$105,000 / yearYou will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
Clinical Research Finance Specialist Iterative HealthClinical Research Finance SpecialistCambridge, MA$75,000–$85,000 / yearBy 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. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
Research Data Specialist - Breast Oncology Dana-Farber Cancer Institute IncResearch Data Specialist - Breast OncologyBOSTON, MARemote$50,500–$56,700 / yearWe strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. Develop knowledge of specialized data sources specific to outcomes data reporting, including routine reaching out to offsite providers to obtain information from medical records at outside sites of care.
Manager, Clinical Research Specialist Training THV AR (Remote US) Edwards Lifesciences CorpManager, Clinical Research Specialist Training THV AR (Remote US)Boston, MARemote$126,000–$178,000 / yearResponsible for maintaining an audit ready environment for all aspects of regulatory and non-regulatory audits as it relates to training (e.g., conducting training, identifying SMEs, ensuring the collection of required documentation.) Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery.
Google Data Specialist Accenture PlcGoogle Data SpecialistBoston, MABuild data pipelines, ETL/ELT processes, and integrations using GCP services such as: BigQuery, Dataflow, Dataproc, Pub/Sub, Cloud Storage. You are eager to apply technical skills, learn advanced Data & AI patterns, and support delivery teams in designing and implementing modern data and AI solutions.
Clinical Research Finance Specialist Iterative Scopes IncClinical Research Finance SpecialistMA$75,000–$85,000 / yearYou will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Senior Clinical Research Finance Specialist Iterative Scopes IncSenior Clinical Research Finance SpecialistMA$85,000–$105,000 / yearYou will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Data Engineer - Project Delivery Specialist Deloitte Touche Tohmatsu LtdData Engineer - Project Delivery SpecialistMA$102,750–$171,250 / yearIndependently and collaboratively lead client engagement workstreams focused on improvement, optimization, and transformation of processes including implementing leading practice workflows, addressing deficits in quality, and driving operational outcomes. Communicate regularly with Engagement Managers (Directors), project team members, and representatives from various functional and / or technical teams, including escalating any matters that require additional attention and consideration from engagement management.
Research Data Specialist II - Breast Oncology Dana-Farber Cancer Institute IncResearch Data Specialist II - Breast OncologyBoston, MA$53,010–$58,900 / yearWe strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. Develop knowledge of specialized data sources specific to outcomes data reporting, including routine reaching out to offsite providers to obtain information from medical records at outside sites of care.
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.
NewClinical Trials Specialist Lahey Hospital and Medical CenterClinical Trials SpecialistBoston, MA$60,000–$95,000 / yearThe Clinical Trials Specialist will help manage research projects including study coordination for an ongoing multicenter randomized controlled trial and managing multiple research projects using observational or real world datasets. The Cardio-Oncology and Heart Failure section combines the use of randomized clinical trials and real-world data with advanced statistical and epidemiological methods to answer questions related to the intersection between cancer and heart disease.
NewAssociate Director, Clinical Data Management, Hybrid Merck & Co IncAssociate Director, Clinical Data Management, HybridCambridge, MA$142,400–$224,100 / yearor B.S. degree, preferably in life sciences, computer science, or related discipline, with at least 6 years' experience in Clinical Data Management or a mix between Data Management and Clinical Research and at least 3 years' experience working with formal project management tools and processes -OR-. Principle Trial Managers will possess end-to-end data management knowledge with strong project management and leadership skills which are transferable from pipeline to process to special initiatives.
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.
NewClinical Trials Specialist Beth Israel Lahey HealthClinical Trials SpecialistBoston, MassachusettsThe Clinical Trials Specialist will help manage research projects including study coordination for an ongoing multicenter randomized controlled trial and managing multiple research projects using observational or real world datasets. The Cardio-Oncology and Heart Failure section combines the use of randomized clinical trials and real-world data with advanced statistical and epidemiological methods to answer questions related to the intersection between cancer and heart disease.
Sr. Manager, Clinical Data Management ModernaTXSr. Manager, Clinical Data ManagementCambridge, MassachusettsRemote7 years of experience must include: Vendor Management; Medidata RAVE, InForm, and Oracle Clinical EDC tools; Clinical Data Management using Biomarker and External data; Utilizing eTMF tools; Study Database Lock processes including Final, Interim, Snapshots, DSUR submission, and Staggered Lock; Study Initiation, CSR Review, and SAE Reporting; J-Review, I-Review, and Clinbrowser; and. Lead the creation and maintenance of study cross functional data review plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plans, coding guidelines, Serious Adverse Events (SAE) reconciliation guidelines, and database lock plans.
Manager Clinical Data Monte Rosa Therapeutics IncManager Clinical DataBoston, MAThis 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.
Senior Manager, Clinical Data Systems Tango Therapeutics IncSenior Manager, Clinical Data SystemsBoston, MA$144,800–$217,200 / yearLead clinical technologies including planning, execution, and delivery of the clinical data activities on Centralized Imaging, eCOA and clinical technologies, implementing secure procedures to initiate best practices and lead data management flow. Oversee facilitation of clinical technologies technical support, data changes, data issue resolution; working with cross-functional stakeholders including Clinical Data Management, Clinical Operations and Biostatistics in order to achieve goals.
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.
Clinical Specialist, Mental Health Google LLCClinical Specialist, Mental HealthMAOur teams are applying our expertise and technology to improve health outcomes globally - with high-quality information and tools to help people manage their health and wellbeing, solutions to transform care delivery, research to catalyze the use of artificial intelligence for the screening and diagnosis of disease, and data and insights to the public health community. You'll utilize not only your clinical expertise but also your excellent listening, communication, and leadership skills to appropriately shape the content, design, and execution of products.
Clinical Pharmacy Specialist - PGY2-ID Residency Program Director Boston Medical CenterClinical Pharmacy Specialist - PGY2-ID Residency Program DirectorMA$109,000–$158,000 / yearThe ID clinical pharmacy specialist oversees antimicrobial stewardship activities, leads the local antimicrobial stewardship committee, monitors antimicrobial use metrics and reports outcomes to hospital leadership and should be an active participant on the system antimicrobial stewardship committee. The ID pharmacist is expected to lead and participate in quality improvement initiatives related to antimicrobial use and patient safety, lead formulary management, guideline development, monitor antimicrobial use metrics and report outcomes to hospital leadership.
Clinical Study Specialist ICON PlcClinical Study SpecialistCambridge, MACompiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders. Tracks and monitors close out activities - study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits.
Sr. Manager, Clinical Data Management Moderna IncSr. Manager, Clinical Data ManagementCambridge, MARemote$130,800–$209,400 / year7 years of experience must include: Vendor Management; Medidata RAVE, InForm, and Oracle Clinical EDC tools; Clinical Data Management using Biomarker and External data; Utilizing eTMF tools; Study Database Lock processes including Final, Interim, Snapshots, DSUR submission, and Staggered Lock; Study Initiation, CSR Review, and SAE Reporting; J-Review, I-Review, and Clinbrowser; and. Lead the creation and maintenance of study cross functional data review plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plans, coding guidelines, Serious Adverse Events (SAE) reconciliation guidelines, and database lock plans.