Responsibilities

• Liaise between company, the sponsor and other internal and external partners to establish, align and confirm data management expectations for the assigned trial.
• Serve as the Data-management representative on assigned project teams, providing proactive support to Project Management for preparing efficient work plans and timelines for data-management activities and deliverables, and data-management input into other departmental deliverables.
• Ensure continuous, accurate and transparent reporting of data management activities
• Participate in internal and external project/team meetings
• Conduct Data Management activities:
  • Prepare Data Management Plan
  • Lead the CRF and database design activities, in collaboration with other internal and external partners (PM, CRA, statisticians, medical experts)
  • Prepare clinical data management documents (Annotated CRF, data-entry guidelines/eCRF user guide, Edit Checks plan, Coding conventions, Deviation list, Data Review plan, Data review minutes) ensuring appropriate quality, content and compliance with regulatory guidelines and company/Sponsor’s SOPs.
  • Program, test or validate the Edit Checks programs using various EDC systems
  • Program specific data listings, patient profiles and deviations listings using SAS
  • Query management
  • SAE reconciliation
  • Ensure the automatic coding and first manual coding of medical data (desirable)
  • Prepare, participate and write the minutes of the Blind Review Meeting
  • Prepare and validate submission datasets and documentation for regulatory submissions (SDTM)
  • Participate in the writing and updating of data-management SOPs, forms and templates

Requirements

• Data Manager or computer programming background.
• Strong knowledge of SAS programming and CDISC standards.
• 5 – 10 years work experience in the practice of Clinical Data Management and programming related to database management in a CRO or Bio/Pharmaceutical setting with experience in all the aspects of data-management activities for a clinical trial (including database design using eCRF, programming and data-cleaning).
• Knowledge of current regulatory regulations, GCP, ICH guidelines in clinical trials, CFR regulatory requirements.
• Good organizational and interpersonal skills.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients
• Excellent ENGLISH in writing and spoken.
• Strong communication skills.