div>Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Reporting to the Associate Director, the Clinical Data Manager, will play a pivotal role in ensuring the integrity, accuracy, and completeness of clinical trial data, contributing to the successful development and regulatory approval of our products.
Marlborough, MA30+ days ago
p>This position reports to the Executive Director, Clinical Data Management, Oncology and is part of the Oncology Data Management function, which supports Sumitomo Pharma America's clinical development programs by ensuring high-quality, compliant, and inspection-ready clinical trial data. The role is responsible for the end-to-end execution and oversight of clinical data management activities across assigned oncology studies and works closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external vendors.
Cambridge, Massachusetts30+ days ago
b>Trial Leadership & Data Management- Develop and maintain key data management documents, including the Data Management Plan, eCRF specifications, completion guidelines, edit check specifications, data validation plan, data transfer specifications, external data reconciliation plans, medical coding plan, and database lock plan. This individual will provide hands-on data management expertise and sponsor oversight of CROs and third-party vendors, partnering closely with Clinical Operations, Clinical Development, Safety, Regulatory, Translational Medicine, and external vendors to ensure timely, accurate, complete, and inspection-ready clinical trial data in accordance with GCP, ICH guidelines, applicable regulatory requirements, data privacy requirements, and Repertoire SOPs.
Your previous roles/job titles may include Clinical Data Manager, Senior Clinical Data Manager, Lead Data Manager, Principal Data Manager, and/or Data Management Project Manager. IQVIA is seeking experienced Clinical Data Management Leads to oversee end-to-end data management delivery for global clinical trials.
div class="content-pay-transparency">New York pay range
$97,000—$120,000 USD
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. 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.
South Boston, MA30+ days ago
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The successful candidate will provide clinical data management oversight of outsourced clinical trials, including but not limited to: project management, vendor management, coordination of internal reviews, and approval of deliverables.
Our base salary is just one component of Decipheras competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable). The position works closely with internal stakeholders and external vendors to deliver high-quality clinical data on agreed timelines.
Watertown, MA30+ days ago
Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Oversight of data collection tools (EDC, DTAs, EDC integrations) and essential documents (DMP, UAT Documents, data edit specifications, annotated case books and data entry guidelines).
Cambridge, MA30+ days ago
ul>Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate's work experience, education/training background and parity with current employees in the same or similar positions.
Watertown, MA30+ days ago
The Senior Manager, Clinical Data Management oversees clinical trial data management from startup through database lock, ensuring high-quality, reliable clinical data in support of development programs under the supervision of the Director of Clinical Data Science. Partner with CROs and vendors to develop and review Data Management Plans, CRF Completion Guidelines, CRF design, database and edit check specifications, database build and validation, data review plans, data transfer specifications, and database lock activities.
Watertown, MA30+ days ago
li>Partner with CROs and vendors to develop and review Data Management Plans, CRF Completion Guidelines, CRF design, database/edit check specifications, data review plans, data transfer specifications, and database lock deliverables. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA.
Waltham, Massachusetts22 days ago
p>To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
Boston, Massachusetts20 days ago
li style="margin-left:0.5in">Manage CROs, EDC vendors, central labs, imaging vendors, eCOA providers, IRT vendors, and other data providers. Review and contribute to key study documents, including data management plans, edit check specifications, CRF completion guidelines, data transfer agreements, and data review plans.
li>Lead 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.
This 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.
li>Experience/training in the following areas: Good Clinical Practices (i.e. GxP Regulations; ICH Guidelines; Good Quality Practices), 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process, Data Management Overview. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.
Cambridge, MA30+ days ago
li>Oversee directly, or through DM team members, EDC design (including eCRFs, DVS/edit checks, DMP development, eCCGs, etc) and EDC user acceptance testing, to ensure EDC meets protocol requirements for assigned programs and studies. Work collaboratively with Statistical Programming, Biostatistics, Clinical Operations, Medical, Pharmacovigilance, and Regulatory staff to meet program or project deliverables and timelines related to clinical data or clinical data systems.
For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
Proactively drive quality and efficiency to meet timelines and milestones for data management in close collaboration with cross functional study team(s) Conduct oversight of data management activities internally and performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet Vor obligations and business objectives throughout study (ies) life cycle i.e. from protocol synopsis through database release and submission. Location: Boston, MA preferred The Senior Data Manager is responsible for all data management activities from study start-up through database lock and archiving and independently supporting the needs of the clinical study and programs of studies.
Needham, Massachusetts28 days ago
ul style="min-height:1.5em">In collaboration with Clinical Sciences, Biostatistics, Clinical Operations, and other key Development functions, responsible for the design of clinical trial databases, which includes, but not limited to, CRF Development, Database Validation, and Data Review tools in accordance with ICH/GCP guidelines and current regulatory requirements. Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need.
Lexington, MA30+ days ago
The Director, Clinical Data Management (CDM) is responsible for oversight, execution, and quality of all data management activities across assigned clinical trials from study start-up through database lock. Develop, review, and approve key study documents including data management plan, case report forms, database build specifications, data transfer specifications, SAE reconciliation plans .
Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: • Craft and convey clear, impactful and engaging messages that tell a holistic story. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.
Seeking a Senior Project Manager / Business Analyst to support strategic Clinical Development Technology initiatives focused on clinical operations, data-driven decision-making, automation, and AI-enabled process improvements. The ideal candidate will have strong pharmaceutical industry experience, particularly within Clinical Operations and Clinical Data Management, along with a proven ability to lead cross-functional initiatives from project inception through implementation.
Worcester, MA30+ days ago
Category All Academic Accounting & Finance Administrative Professional Administrative Support Advancement Biotechnology Environmental Health & Safety Executive Faculty Healthcare Human Resources Information Technology Interns Library Maintenance and Facilities Management Nursing Office Assistant Other Post Doc Professional Technician I Public Safety Research Residents Retail & Dining Services Staff Assistant Staff Associate Volunteer Business Unit All ForHealth Consulting UMass Chan Medical School Location All Bedford Boston Brockton Brockton Canton Charlestown Danvers Devens Fall River Fitchburg Holyoke Jamaica Plain Jamaica Plan Lincoln Mattapan North Hampton North Quincy Pocasset Shrewsbury Springfield Taunton Tewksbury Waltham Westborough Westfield Woburn Worcester Wrentham Type All Contract to Permanent (Full Time) Full-Time In-Family Promotion Intern (Full Time) Intern (Part Time) Part-Time Perdiem Post-Retiree Temporary Volunteer Within 5 miles 10 miles 25 miles 35 miles 50 miles 75 miles 100 miles Keyword SUBMIT When you join the UMass Chan Medical School team, you join us in advancing together to improve the health and well-being of our diverse communities throughout Massachusetts and across the US and the world. Apply Refer a Friend Back Clinical Data Specialist II Job Number: 2026-49553 Category: Healthcare Location: Worcester, MA Shift: Day Exempt/Non-Exempt: Non Exempt Business Unit: ForHealth Consulting Department: ForHealth Consulting - Molecular Lab Unit (General) - W416939 Job Type: Full-Time Union Code: Non Union Position-W25-Non Unit Classified Num.
li>Drive critical study milestones, including site activation, enrollment progress, patient retention, data cleaning, and database lock, proactively addressing operational challenges common to CNS trials. Lead day‑to‑day clinical trial operations, coordinating cross‑functional partners (Clinical Development, Data Management, Biostatistics, Regulatory, Safety) to ensure efficient trial execution and alignment to program objectives.
Boston, Massachusetts30+ days ago
Worcester, MA30+ days ago
POSITION SUMMARY: Under the general supervision of Manager or designee, the Clinical Data Specialist II participates in the daily reporting of newborn screening results to members of the external clinical community to ensure the timely reporting of clinically significant newborn screening results. In keeping with established protocols, the Clinical Data Specialist II works to identify the medical healthcare provider and contact information for infants needing newborn screening reports and follow-up and prepares electronic and hard-copy patient folders for clinical reporting.
p>Kura developed and is commercializing KOMZIFTI® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. Reporting to the Executive Director of Quality Assurance, the Senior Manager, Clinical Quality Assurance (CQA) is responsible for supporting the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for all clinical development programs.
The Faja Lab within the Laboratories of Cognitive Neuroscience is seeking a full-time Computational Health Informatics Data Manager II to oversee data from questionnaires, behavioral observations, neuroimaging, wearable physiological recordings, genetic and other biological data in a naturalistic, longitudinal study. Familiarity with established clinical data repositories and Electronic Data Capture systems like REDCap for data types including but not limited to clinical assessment, electronic health record, electroencephalography, digital biomarkers, and biospecimens.
Partnered with Ferrer for the commercialization and co-development of pridopidine, we plan to start two key late-stage trials to support potential approval globally in ALS and in HD in the first half of 2026.
About the role
We are seeking a dynamic Regional Clinical Trial Manager to join our team and to oversee and manage regional operational activities of global pivotal trial/s in neurodegeneration.
About Prilenia
Prilenia, a private biopharmaceutical company with a highly committed and talented global team, is seeking a Regional Clinical Trial Manager located in the US.
Prilenia has a simple but urgent mission – to bring transformative medicines to people affected by devastating neurodegenerative diseases.
p>ESSENTIAL JOB FUNCTIONS: Reporting to the Executive Director of Quality Assurance, the Senior Manager, Clinical Quality Assurance (CQA) is responsible for supporting the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for all clinical development programs.
Kura developed and is commercializing KOMZIFTI (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition.
Boston, Massachusetts30+ days ago
li>Fluency in FDA device regulations (IDE, De Novo, 510(k) clinical requirements), ICH-GCP, ISO 14155, and familiarity with SaMD-specific guidance (e.g., FDA Digital Health frameworks).
Collaborate cross-functionally with regulatory affairs, product, engineering, data science, and legal teams to ensure clinical strategies align with product development and submission timelines.
This is a hands-on, operationally intense position for someone who knows how to stand up a study from scratch, manage third-party clinical sites, write IRB and informed consent documents, oversee data management, and drive studies to completion on time and on budget. Collaborate cross-functionally with regulatory affairs, product, engineering, data science, and legal teams to ensure clinical strategies align with product development and submission timelines.
Cambridge, MA30+ days ago
All Job Posting Locations: Cambridge, Massachusetts, United States of America, Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America. • Work closely with other technical leaders, such as Ontology and Knowledge graph Engineers to design and deliver future-proof, AI-ready data systems aligned with Oncology R&D business needs.
For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
p>All Job Posting Locations: Cambridge, Massachusetts, United States of America, Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America.
The Senior Manager, Oncology Data and AI Systems will focus on building data and AI systems in Oncology R&D and support projects from across the business including Clinical, Pre-Clinical, Real World Data (RWD) and 'omics platforms.
p>You'll architect the financial intelligence framework that guides critical investment decisions across our pipeline, leading a team of two talented professionals while partnering with senior leaders across Finance, Clinical Operations, and beyond. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
Watertown, MA30+ days ago
Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Work within a matrix environment, collaborating with medical directors, regulatory affairs, translational medicine, clinical operations, data management, biostatistics, and other departments to drive clinical development programs forward.
Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management at a medical device/drug company, clinical research site, or CRO. Assist data management staff with clinical data review and collection of data from sites to maintain integrity by reviewing protocol deviations, adverse events, data inconsistencies, outliers, other issues as identified.
Quincy, Massachusetts21 days ago
Other: • Collaborates closely with, providing oversight as needed to, the Clinical Manager/Charge RN acting as nurse manager, the Medical Director, and the physicians regarding the direct patient care responsibilities within the facility to ensure the provision of outstanding quality of patient care, as defined by the FMS quality goals, and compliance with the pertinent company policies and procedures. • Demonstrated leadership competencies and management skills for the position, including excellent communication, customer service, continuous quality improvement, relationship development, results orientation, team building, motivating employees, performance management and decision making.
The Manager, Integrated Care Management -Nursing works collaboratively within Clinical Services and other Point32Health partner departments to identify and address opportunities to improve service, reduce administrative cost and support department, Line of Business (LOB) division, and organizational business goals. Facilitate and enhance team collaboration to optimize program and member outcomes through integrated services,
Facilitate collaboration with internal and external stakeholders to maximize partnerships for case management program success, including alignment with provider network and employers.
The Manager, Integrated Care Management -Nursing works collaboratively within Clinical Services and other Point32Health partner departments to identify and address opportunities to improve service, reduce administrative cost and support department, Line of Business (LOB) division, and organizational business goals. Facilitate and enhance team collaboration to optimize program and member outcomes through integrated services,
Facilitate collaboration with internal and external stakeholders to maximize partnerships for case management program success, including alignment with provider network and employers.
p>Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.
p>Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.
p>Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.
Watertown, MA30+ days ago
Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.