Summary Of Responsibilities
- Ensures that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
- Demonstrates capability to read and follow study timelines for on-time deliverables.
- Potential to assist with inputs on study design or capable to make suggestions to study timelines when warranted.
- Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data.
- Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data.
- Generate, resolve and track queries to address problematic data identified during aggregate data review activities.
- Interacts with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required.
- Generate and QCs data listings for internal data review.
- May assist or create dummy data to test edit checks and to test database screen design and functionality.
- Assist or create dummy data to test SAS reports and data listing.
- Demonstrates the ability to review Edit Check Specifications and Database specifications.
- Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
- Runs study status reports in preparation for Sponsor meetings and to deliver on specific Sponsor request.
- Assist with the completion of Database Lock and Unlock activities.
- Supports the training of new staff on project specific Data Management processes.
- Performs any other duties as assigned.
Qualifications (Minimum Required)
- University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
- Fluent in English, both written and verbal.
Experience (Minimum Required)
- 3 to 5 years of relevant work experience with increasing responsibility in data management with knowledge of one (1) or more therapeutic areas.
- Demonstrated time management skill and ability to adhere to project productivity metrics and timelines.
- Knowledge of medical terminology is preferred.
- Knowledge of effective clinical data management practices.
- Knowledge of science or a scientific background is preferred.
- Good oral and written communication skills.
- Demonstrate time management skill and ability to adhere to project productivity metrics and timelines.
- Demonstrate ability to work in a team environment and collaborate with peers.
- Demonstrate good organizational ability, communication, and interpersonal skills.
- Demonstrate team working skills and good collaborator skills.
- Demonstrate a constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.
Physical Demands/Work Environment
- Office and/or home-based work environment.
- May require overtime and weekend work as required.
- Should be willing to work in flexible shifts as per business requirement.