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.
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.
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.
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.