Job Description

India, Remote
Job ID R0000011229 Category Data Management

ABOUT THIS ROLE

Key Accountabilities:
Accountability
Supporting Activities
Set-Up, Maintain, Revise, Close-Out Electronic Data Capture Systems

• Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper based and/or web based
• (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable.
• Lead and supervise and/or create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.
• Accountable for first time quality on all deliverables.
• Provide feedback for study programmers on the creation of eCRF\xe2\x80\x99s following SOPs and internal process guidelines.
• Provide input into and negotiate database setup timelines. Ensure that timelines are adhered to by:
• Actively assume activities on a project as required.
• Monitor project resourcing and identify changes in scope.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work to ensure first- time quality.
• Interact with Sponsors and Data Management Leaders as the key contact with regard to programming related issues.
• Provide technical support and advice to the internal team.
• Ability to lead and support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies on multiple projects simultaneously.
• Lock/Unlock databases in accordance with guidelines and SOPs. Approve changes made to databases (as required).

Support Projects & Technologies

• Assist in providing technical solutions to internal or external/client enquires.
• Support to build or integrate systems within the GDO Area. Execute other programming languages and processes within the GDO area. (e.g. Clinical Trial Management System, Safety Systems, Coding Systems)
• Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized

Documentation

• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams.
• Maintain technical documentation that is applicable to the Clinical Database.

Support Initiatives

• Participate in the creation of standards, either through tools, libraries or processes, as required for GDO to ensure efficient, effective and optimal processes.
• Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies

Act as a mentor and/or SME

• Provide relevant training and mentorship to staff and project teams as appropriate.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.
• Assist in providing technical solutions to internal or external client enquires.
• Maintain and expand local and international regulatory knowledge within the clinical industry.

Skills: \xe2\x80\xa2 Excellent English written and oral communication skills. \xe2\x80\xa2 Demonstrate ability to learn new systems and function in an evolving technical environment. \xe2\x80\xa2 Attention to detail.

• Ability to work together with a team (including international teams as required) as well as independently.
• Work effectively in a quality-focused environment.
• Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
• Business/Operational skills that include customer focus, commitment to quality management and problem solving.
• Good business awareness/business development skills (including financial awareness).
• Work effectively in a quality-focused environment.
• Strong leadership ability.
• Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
• Demonstrate commitment to refine quality processes.

Knowledge and Experience:

• Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).
• Experience working with at least one system used within the Clinical Trial process (e.g. SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting).
• Relevant Clinical Trial industry experience.
• Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.

Education:

• Bachelor\xe2\x80\x99s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience

#LI-REMOTE