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.

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