The Associate Director, Clinical Data Management will be responsible to support all aspects of data management from study start-up to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer specifications.

The Associate Director, Clinical Data Analyst, has a critical role in the delivery of high-quality external data across Dyne's development pipeline by proactively identifying, measuring, and mitigating risk prior to acquisition of non-electronic data capture (EDC) data.

Develop safety data review plans (SDRPs) with clinical reviewers in advance of initial scoping meetings. Lead meetings with clinical reviewers and statistical reviewers to present results from data quality assessments and standard safety data analyses.

Reporting to the Executive Director, CDM, the Associate Director, CDM will be a highly motivated, quality-focused individual who can work collaboratively in a fast-paced, cross-functional team environment, and will manage data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals.

The Clinical Research Data Associate III manages the data for assigned research studies. Working Title : Lead Clinical Research Data Associate. In addition, may supervise clinical research staff or clinical data managers, perform sophisticated statistical analysis, and work with bioinformatics to develop and maintain trial management and validation systems.

The Principal Clinical Data Manager is responsible for the oversight and management of Imara assigned studies throughout the full study lifecycle, from study start-up through database archive.

Clinical Data Specialist III Work Arrangement: Hybrid (On-Site and Remote mix) Requisition Number: 246266 Regular or Temporary: Regular Location: Durham, NC, US, 27710 Personnel Area: MEDICAL CENTER Date: Jun 5, 2024 School of Nursing Established in 1931, Duke University School of Nursing is among the top-ranked of the nation’s nursing schools.

Supports accurate data abstraction and chart review as needed within established timeframe (e.g. for submission deadlines). Participates in continual learning of abstract/data entry issues and various monitoring activities, creating revision as needed in monitoring processes, procedures and guides as appropriate to their role.

Reporting relationship to Asset Lead; Director, Group Lead; Associate Director, Asset Lead; Senior Manager, Asset Lead; Manager, Clinical Data Scientist, Clinical Data Sciences, CDS.

The Community Practice Clinical Data Coordinator at Trial Library will play an integral part in expanding access to cancer clinical trials by pioneering pre-screening efforts in community oncology settings.

Proficiency with Medidata Rave EDC, Clinical Data Repositories and Visualization software. The Clinical Data Manager will be responsible for daily data management tasks for all phases of clinical trials including CRO/vendor oversight and support other functional areas such as clinical operations, statistical programming, and biostatistics.

Working knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide coding dictionaries such as MedDRA.

Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management. 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.

Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence.

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Scientist (CDS) is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio.