About the department
- The key objective of the department is to ensure high quality data delivery to the stakeholders.
- The involvement of various groups in data management is significant in key stages of trial setup, conduct and closeout.
- The major activities handled include CRF Design, Database set-up & Programming, Data Entry, Data Validation, Medical Coding, Lab data handling, Data analysis & migration, Database Lock, Hyperlinking and Bookmarking and Project Management.
- These opportunities have in turn fostered a deeper understanding with an ability to drive, contribute to process and share best practices while leveraging cross-cultural collaboration towards a unified mission to achieve clean data.
- Coordinate the medical coding processes across studies within a clinical program in order to ensure consistency for smooth conduct/closure activities of a clinical trial.
- Perform timely and accurate categorization of verbatim term text in assigned clinical trials to standard medical dictionaries and nomenclature , using the TMS Application.
- Approve codes, or if codes are not approval initiate recoding for the assigned dictionaries and on a need basis.
- Coder is responsible for a specific trial and is the contact person for coding questions.
- Reports coding status on regular basis as agreed with Data Manager.
- Acts as an information resource for coding issues within all trials and identify any changes needed to update dictionaries.
- Well-versed with coding procedures and regulatory requirements.
- Is in compliance with internal and external coding procedures and regulatory requirements.
- Establishing and maintaining routine interactive procedures with trial/project clinicians for review, discussion and approval of coding results.
- Independently manages the relations with clinicians, drug safety, statisticians, medical writers, and other project team members to ensure proper input and ensure that output meets mutual expectations.Independently manages task prioritization and timelines.
- Assists department manager to coordinate multiple tasks and resources.
- Maintain contact and coordination with key coder to ensure global standard of coding practice.
- Provide coding related training within Clinical Operations.
- Contribute to continuous improvement of coding methodology and tools:
- Independently coordinate with Medical Coding Supporters, Key Coders Forum, and monitor external vendors to assure that the optimal tools are applied in production process
- Facilitate update and review coding specific processes, documents, and SOPs.
- Training New coders
- The Medical Coder should have attention on irregularities and deviations and should be able to foresee, identify and diagnose problems as well as making relevant proposals for actions.
- The Medical Coder should be able to identify the stakeholders’ need for data and information.
- Preferably 3 years of data management experience and the majority of this with medical coding.
- Preferably 2 years of experience in Information Technology.
- Preferably knowledge of Clinical Development.
- Preferably experience in project management.
Working with Us:
- We create value by putting patients first.
- Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us.
- Working here is not just a way to make a living, but a way to make a differenc