Job Details

Senior Clinical Data Coder - Remote

Bloemfontein, South Africa | Full time | Home-based

Manage single and multi-service projects, ensuring quality deliverables on time, within budget and to the customer's satisfaction; Provide expert skills as part of a Clinical Data Management (CDM) team to provide quality data that meet customer needs; Provide leadership to the team in the area of coding, project planning and execution, financial management, communication and milestone tracking; Viewed as an expert in coding of clinical data.

Essential Functions

• Serve as an account lead, or 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.
• Manage the customer relationship for the project team including active participation in coding related customer negotiation on timeline, budgetary and other issues
• Provide support to lead coders on one or more large global studies
• Manage the relationship with a customer
• Serve independently as a Lead Data Coder and/or Coding reviewer for one or more projects
• May serve as a DOC or DTL for one or more projects
• 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 provide due diligence for out of scope activity
• Manage resource capacity for the project team
• Mentor other team members in training and developing coding expertise
• Independently bring project solutions to the Coding and CDM team
• Identify and implement processes and quality improvement initiatives in the DM and coding function
• Developing and implementing best practices in the team
• Manage the development and implementation of new technologies
• Demonstrate scientific and research temperament by presenting at, or participating in local and international forums
• Responsible for identifying and implementing process improvements using established methods (principles of lean and six sigma) in collaboration with experts
• Provide review and expert opinion in developing, revising, and maintaining standard core operating procedures and work instructions
• Perform other duties as directed by the DOC, DTL or Manager, or meet objectives as assigned
• 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 Pref
• 7 years 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.
• 5 years thesaurus management experience is essential
• Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD, ICD9, etc.).
• 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.
• 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.
• Excellent English written and oral communication skills.