Senior Clinical Data Coder - Remote
Job Title: Senior Clinical Data Coder - Remote
Job Location: Durban, South Africa
Job Location Type: Home-based
Job Contract Type: Full time
Job Seniority Level:
Job Overview
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 instructi