The Clinical Data Manager performs functions related to data and information management. This includes the management, coordination and documentation of data collection methods, change control, data security, and data retention within the project(s) task.
- Act as the project manager for stand-alone or multi-data management software application development project(s), effectively manage the activities of computer system development and validation life cycle and vendors in a manner that ensures all timeframes and targets are met with the highest quality to the company and sponsor’s satisfaction, and that costs are kept under control.
- Provide Clinical Data Management support to Clinical Operations team and/or study project, Clinical Data Management team and Biostatistics team
- Participates in the review of clinical research documents (e.g. Protocols, Case Report Forms, Reports and Statistical analysis) Provide leadership and guidance to Data Coordinators
- Develop Case Report Form (CRF/eCRF), electronic and/or paper
- Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
- Reconcile electronic data transfers from vendor to Sponsor
- Manage and update project timelines
- Develop presentations and present at Investigator meetings
- Provide support and act as the data management point person to the Sponsor, CROs, vendors, clinical sites, and scorers
- Creation, completion, organization, and tracking of all data management documentation
- Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit. Lead EDC database (DB) specification process. Develop test scripts and execution logs for User Acceptance Testing (UAT).
- Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report. Perform data review, query generation/resolution and data updates
- Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit. Train Data Coordinators on data QC procedures and edit checks for each study
- Provide training and guidance to the Sr. data coordinator and data coordinator (e.g. data entry, oversight of data transfers, etc.) when needed/assigned
- Collaborate with IT and implementation team(s) to address clinical application requests and/or changes to clinical database systems. Assist in reconciling AE/SAE data in Safety DB and/or Clinical Database
- Coordinate the integration and reconciliation process that will be applied to external electronic data loads
- Track study progress and issue periodic status reports as needed
- Communicate with all operational departments regarding project status/issues
- Follow and ensure compliance with Good Clinical Practices (GCPs)
- Adhere to corporate policies and procedures
- Other duties as assigned
Salary would depend on the candidate's location. For New York City the salary range is $110,000 -$135,000.
- The position requires at least a Bachelor’s Degree with minimum of 5 years of experience in Clinical Data Management in Clinical Trials.
- In lieu of a Bachelor’s degree a minimum of 6 years industry experience is required
- At least 2 years of working experience on Medidata RAVE platform, build EDC in Medidata RAVE or equivalent EDC platform is preferred.
- Experience of all data management processes from study start-up to study close-out
- Knowledge of medical terminology, pharmacology, anatomy, and physiology.
- Experience with at least one clinical data management system (CDMS) including direct experience and/or understanding with database design, set-up and user acceptance testing; edit check development and/or programming and validation; management of data entry and queries; and study change control.
- Data and computer system information management experience, medical terminology, relational database knowledge, programming experience (any language), and experience overseeing projects required.
- Good communication, organization, and documentation skills are expected.
- Good Clinical Practices training.