Senior Clinical Data Manager (Associate Director)
The Senior Clinical Data Manager is responsible for data management activities across multiple studies from study start-up through study closure to ensure completion per established project team goals and objectives. The Sr. CDM will report to the VP, Clinical Operations and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical data are complete, high quality and delivered on time and budget.
- Leads EDC development, including CRF development, EDC specification process and sponsor User Acceptance Testing including test scripts and execution logs, validation documents such as edit check documents, issue logs, UAT summary reports, etc.
- Ensures complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans.
- Ensures clinical data within EDC and other databases is of quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock Reviews and reconciles clinical database with external database/datasets.
- Reviews coded adverse events and concomitant medication data.
- Reviews data for discrepancies and communicates any outstanding issues.
- Leads data cut / database lock process and release of data for analyses.
- Coordinates transfers of SAS datasets or electronic data transfers from CROs.
- Monitors and tracks the quality of all data management deliverables ensuring audit practices have been enacted to validate the quality and assurance of database content and supporting documents, from CROs as well as other external electronic data transfers.
- Actively participates in team meetings and presents Data Management concerns and issues.
- Effectively manage contracted vendors, or vendor groups within CRO, to ensure data are complete, accurate and delivered within agreed on timelines.
- Collects and uploads data management documentation to the study TMF.
- Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practice.
- Bachelors Degree or equivalent in life science, computer science, or related discipline.
- 10+ years of experience working within a pharmaceutical or CRO environment, with experience in managing Phase I, II and III studies, from start-up through closure.
- Demonstrated proficiency in the data management processes.
- Experience in managing external EDC vendors for Data Management.
- Understanding of Clinical Data Interchange Standards Consortium (CDISC), CDASH, and SAS® terminology.
- Understanding of the coding process and terms in MedDRA, WHODRUG and CTCAE.
- Thorough knowledge of applicable regulatory rules and guidelines.
- Excellent organizational skills and attention to detail.
- Effective communication and interpersonal skills.
- Able to set priorities and juggle multiple demands.
- Able to think critically and be a proactive problem-solver.
- Able to work independently while exercising initiative, flexibility and sound judgment.
- Comfortable working with different levels of the company including senior level management.
- Demonstrated proficiency in Microsoft Word, PowerPoint and Excel.
- Ability to operate in alignment with Pliant’s values