$80K — $100K *
The Senior Data Manager will be responsible for oversight of clinical data management (CDM) activities for assigned programs and/or studies. The successful candidate will proactively oversee CDM execution of CRO outsourced and/or FSP managed trials from study startup through study closure in support of trial objectives and corporate goals. This position reports to the Director of Data Management.
Provide study and/or program-level oversight of clinical data management activities.
Collaborate with clinical study teams and vendors to meet project deliverables, including data acquisition, quality checking and reporting in compliance with GCP, SOPs and regulatory requirements.
Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans – identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF).
Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality.
Perform thorough development testing of the eCRF prior to deployment, inclusive of creating or overseeing vendor User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable.
Ensure completeness, accuracy and consistency of clinical data across all assigned studies.
Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel.
Report query trends and data/query metrics to the study team.
Review data transfer specifications/agreements for consistency with study and program needs.
Represent data management at Investigator Meetings and may present EDC and Case Report Forms to investigators.
Assist in implementation of key performance and quality indicators.
Track and review key performance indicators on data entry, source verification, and query status; perform quality control on those metrics to ensure accuracy.
Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.
Review data listings prior to final database locks.
BS/BA in Life Science or related discipline.
3+ years of clinical data management experience in the pharmaceutical/CRO industry. At least 1 year on the sponsor side.
3+ years of Electronic Data Capture (EDC) experience including Medidata Rave.
Global clinical trial and CRO management experience.
Strong working knowledge of FDA & ICH/GCP regulations and guidelines.
Strong knowledge with CDISC (CDASH/SDTM), medical dictionary coding standards, FDA and ICH guidelines, GCP, 21 CFR Part 11, Clinical Data Management best practices.
Experience with SAS or SQL programming techniques with clinical data management application a plus.
Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment.
Experience with DIA TMF reference model pertaining to CDM documentation.
Ability to perform limited travel as needed.
Valid through: 8/17/2020