Review documentation and requirements for new projects and anticipate impact to Data Management (DM) standards/processes
Collaborate with client team for all requirement gathering of CRFs, edit checks, subject calendars, user management, reporting requirements etc
Collaborate with internal project team (both onshore-offshore) as needed to stay abreast of and changes that could affect data collection, cleaning, change requests and/or transfers
Develop Data Management Plan (DMP), maintain DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
Develop and review Protocols, Case Report Forms, Reports and Statistical analysis reports.
Develop trial database, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
Manage eSource/EDC users and other Clinical databases, including but not limited to, compiling master user lists and activating/deactivating user accounts.
Perform user training both web-based and in-person at client locations, and create user guides.
Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.
Bachelors degree in Technology, Medicine, Science or related field.
At least five (5) years data management and/or related work experience in the pharmaceutical or CRO industry.
Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
Working knowledge of Clinical database applications such as EDC and CTMS.
Excellent verbal and written skills, good organizational, interpersonal, and team skills.
Applicable knowledge working with other clinical databases such as Oracle Clinical, Medidata Rave, etc.
Experience with AE/SAE Coding, will be nice to have.
Experience with working on Phase I- IV study trials.
Ability to travel to site locations as needed (10-25%)