Senior Associate, Central Testing Analyst

Role Responsibilities

Perform 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 assigned deliverables.

• 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 initial Data Management meetings with Clinical Data Scientist or Study Data Manager to understand the expectation and scope of the study requirements.
• Ensure work carried out in accordance with applicable standard operating procedures and working practices.
• Understand the Protocol and provide input to Study Team on Database Design and Edit Check Specification as appropriate.
• Review the Edit Check Specification, write UAT test Scripts.
• Perform UAT for DMW Validation Checks and SRDM UAT for assigned studies
• May be involved in Validating the Automation Tools for Data Management
• Perform the peer review for programming checks.
• Perform the QC on metadata listings.
• Participate in UAT feedback meetings.
• Streamline/Standardize the Scripts for Standard Forms/Edit Checks.
• Validation of Manual queries/Listings (Standards/Therapeutic Specific).
• Able to understand the Post Production Changes in Database during conduct and provide clinical/technical suggestion.
• Track the lessons learned and share the knowledge across the team.
• Complete all the documentation related to study and share it with study Team.

Qualifications

• Bachelors degree minimum requirement. Health Sciences experience or Technology degree preferred. At least 4 years of relevant 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
• Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review)
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

Please use the below link for job application and quicker response:

https://lifelancer.com/jobs/view/aa3ebd8270f2ecfc8d77e1fbd7fe0bb8