Description
We are seeking an experienced Clinical Coding Analyst to join our team. As a Clinical Coding Analyst, you will manage single and multi-service projects, ensuring quality deliverables on time, within budget and to the customer's satisfaction. You will provide expert skills as part of a Clinical Data Management (CDM) team to provide quality data that meet customer needs.
Essential Functions
- Serve as internal or external point of contact on standalone coding studies or accounts.
- Maintain post-coding dictionary up-versioning synonym and coding reconciliation to align coding to latest dictionary versions.
- Perform Dictionary up-versioning activities.
- Perform external verbatim coding of data from non-EDC sources in line with required coding dictionary versions.
- Perform comprehensive quality control procedures.
- Perform Serious Adverse Event (SAE) coding reconciliation activities.
- Collaborate with customers and develop solutions and action plans for issues, escalations and road blocks.
- Proactively identify, solve quality issues and deliver projects as per agreed timeline.
- Identify and implement processes and quality improvement initiatives in the DM and coding function.
- Provide review and expert opinion in developing, revising, and maintaining standard core operating procedures and work instructions.
- Develop and maintain good communications and working relationships with the CDM team and client stakeholders.
Qualifications and Experience
- High School Diploma or equivalent Pharmacy, Dental, Medical, Nursing, life sciences or related field qualification or educational equivalent.
- Advanced English both written and communication skills, works in a global team.
- 3-4 years of relevant experience in clinical trials within a similar function, including proven competence in managing the delivery of coding or/and other data management processes for multiple global projects, also including experience in handling complex customer negotiations and bid defense meeting.
- Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD, ICD9, etc.).
- Thesaurus management experience.
- Excellent knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks.
- Advanced knowledge of data management processes and systems and advanced ability to apply this knowledge in practice - Medidata Rave is preferred.
- Excellent understanding of clinical drug development process (detail oriented).
- Good project management skills related to all phases of clinical studies.
- Excellent knowledge of operating procedures and work instructions and the ability to apply them in practice.