Summary

Utilize standard and/or sponsor custom dictionaries to code Adverse Events, Medical and Surgical Histories, Medications and any other sponsor requested medical terminology required for projects. Ensure coding guidelines and company SOP s are adhered to and dictionary versions / updates are maintained as appropriate for the project. Back up to Manager Clinical Coding and Data Management as required.

Responsibilities

Tasks may include but are not limited to:

- As a priority, provide coding support for projects including:
- Coding activities for Study start up on existing and new EDC databases
- Input into the Data Management Plan, performing User Acceptance Testing, including review of Database Specifications and CRFs
- Performing manual coding of medical and medication terms, generation and review of coding consistency reports for accuracy and submission of coding reports to internal Medical Monitor / peer review and for sponsor review at periodic time points specified for the project.

- Coordinate dictionary implementation and version updates for projects as applicable.
- Communicate effectively with Sponsors on general and project specific coding issues, as needed.
- Ensure coding is performed and delivered consistently both internally and externally with the highest quality and timelines are met according to study requirements.
- Coordinate dictionary licence validation checks and Worldwide licence renewal process.
- Identify coding process and technology improvements, implement changes, monitor the outcome and recommend further action.
- Provide leadership/mentorship to support junior staff performing coding activities.
- Attend sponsor and team meeting as necessary.
- Maintain solid awareness of study coding budget and potential CIS/OOS issues related to coding for studies.




- Provide regular updates to management regarding coding deliverables, metrics, coding issues, etc. as necessary.
- Ensure clinical coding operations are conducted according to WCT SOPs.
- Act as back up to Manager Clinical Coding and Data Management as required.
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Other skills and abilities

- Must be computer literate and numerate with a willingness to adapt to various computer systems. It is essential that the job holder works with close attention to detail and to be questioning about the validity of the data being entered.
- Excellent time management and man management skills.
- Ability to prioritize and manage multiple coding tasks and to prioritize workload accordingly with attention to detail.
- Very valuable interpersonal and communication skills and the ability to operate effectively in a global work environment.

Requirements

- Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience Trained/experienced in coding with industry standard dictionaries (e.g., MedDRA, WHO-DD)
- A minimum of 3 years of experience in clinical data coding or a related role within the pharmaceutical, biotechnology, or medical device industries.

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Data Coding Specialist (Thiruvananthapuram)
🏢 Worldwide Clinical Trials
📍 Thiruvananthapuram