Responsible and accountable for activities, including but not limited to the testing of CRF design, Database building, Acquisition & Processing of electronic data such as external eData, Lab Data, ECG Data, PK/PD Data, etc. Data extraction, Data Visualization; Data and Documentation Processing, CRF and Database edit checks/validation and validation of exceptional reports/listings.
Accountable for high quality and on time delivery for task assigned to UAT team.
Ensure the consistent use and application of applicable data standard and ensures data quality and consistency across programs and repositories.
Solid knowledge/understanding of the Software development, Lifecycle testing methodology; document management.
Participate in Data Management meetings with Clinical Data Scientist or Study Data Manager to prioritize and revisit UAT timeline.
Ensure work carried out in accordance with applicable standard operating procedures and working practices.
May involved in special project and automation projects in UAT space
May perform the peer review for new activities.
Conduct weekly team meeting
Participate in training and mentoring for UAT testers and Data Managers
Participate in UAT feedback meetings and CDS forum to represent UAT team.
Streamline/Standardize the Scripts for Standard Forms/Edit Checks.
Validation of Manual queries/Listings (Standards/Therapeutic Specific).
Track the lessons learned and build knowledge repository.
Drive innovation and continuous process improvement session for UAT team
Track the status of ideas proposed and bring it to closure
QUALIFICATIONS
Bachelor’s degree minimum requirement. Health Sciences experience or Technology degree preferred. At least 10 years of experience in Clinical Data Management, performing complete data review activities, in a CRO or a Pharma Company.
Must have experience writing test cases and performing UAT
Previous experience within a database management role, understanding key processes and principles associated with CRF design, database build (including edit checks, validation and outputs), data transfer activities, listing and reporting. Awareness of clinical development and pharmaceuticals as a regulated industry
Awareness of healthcare regulatory authorities (e.g. FDA, Health Canada)
Ability to learn clinical data management processes and principles in area of responsibility.
Demonstrates required verbal and written communication skills including ability to communicate remotely
Capable to learn technical data systems
Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
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