Senior Clinical Coding Specialist

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

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 SOP’s.
• 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 good 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.

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