Trainee Analyst position is responsible to learn and apply knowledge/ training on the tasks assigned on a day-to-day basis by adhering to related GSK standard operation, guidance, and procedural documents by ensuring quality and delivery according to set timelines with minimal supervision.
As a trainee Analyst deputed in DS&M sub-functions, at minimum would carry out the following responsibilities:
- If in the capacity of a Data Management role: End-to-end data review and data cleaning activities on a day-to-day basis for the assigned study/studies.
- If in the capacity of a Data Standards role: Deliver timely and quality review of Data Standards and manage standardization activities.
- If in the capacity of a SDTM & Programming role: Ensure timely and quality development, validation, and review of SDTM programs to support study-level conversion of clinical trial data and to ensure various aspects of SDTM activities are thoroughly and accurately conducted.
- If in the capacity of a Coding role: Ensures timely and quality delivery of coded terms, (for Adverse events, concomitant medications, medical histories, medical procedures, etc.) and the effective usage of medical and drug terminology, for clinical trials and other databases as needed across GSK.
- If in the capacity of a Data Acquisition role: Responsible for the technical development of electronic Data capture (eDC) and/or Electronic Patient-Reported Outcomes (ePRO) solutions and/or the technical acquisition of vendor data.
- If in the capacity of a Validation role: Ensure various aspects of a clinical study are thoroughly and accurately tested that includes eDC/eCRF rules, User Acceptance Testing (UAT), backend SAS checks, and other non-eDC aspects are validated to company and industry standards.
For any sub-function, the must-have responsibilities will include:
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- Engage in activities that enhance automation in a process, involve in tool maintenance and development.
- Apply technical knowledge on a need basis for any of the following – Programming / UAT / Data cleaning & Analysis / Validation / Regulatory submissions.
- Assist in the creation and maintenance of Quality plan and implementation at study level.
- Ensure all task-related documents are accurate and present in the eTMF system.
- Support activities for process and tool improvement.
- Adhere to the relevant departmental SOPs, corporate policies, regulatory requirements, and industry best practices.
- Compliant in completing all task-related trainings via LMS and ILT.
- Provides relevant reports, status updates, feedback on trends observed in day-to-day tasks.
- Contributes to after-action reviews (success or failure) to share learnings and propose improvements for the future.
- Involve in interaction with IT, Clinical Systems team and the vendors that are hosting and/or supporting the applications.
- Bachelor’s Degree, in scientific or business discipline
- Life-science or related medical/clinical area ranging from Fresh Graduates to upto 2 years of Clinical Research or Information Systems or relevant scientific experience and demonstrated good collaboration and communication skills
- Detail oriented, organized, ability to grasp information
- Display interpersonal skills
- Demonstrate effective communication skills within a matrix environment
- Team spirit – ability to facilitate interfaces within extended network
- Ability to manage priorities within stipulated timeframe
- Ability to anticipate changes and be flexible in their implementation
- A solution-oriented attitude
- Thorough computer skills, understanding of general data flow & interfaces
- Awareness of drug development process and working knowledge of GxP
- Awareness of converting structured and unstructured data from various sources
- Ability in developing utility macros
- Proficient in Microsoft Office tools
- Understanding of clinical trial process and clinical systems are added advantage
- Awareness of CDISC standards (CDASH, SDTM, ADaM) is added advantage
- Awareness of Clinical Dictionaries – MedDRA and WHODD is added advantage
- Understanding of regulations including ICH-GCP and 21 CRF part 11 is added advantage
- Programming skills required if deputed in sub-function – Data Standards and SDTM & Programming (e.g., SAS, SQL, Cognos), sub-function – Validation (e.g., automation tools like Selenium, HP ALM), sub-function – Data Acquisition (e.g., PL/SQL, SAS, Python, C++)