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 instructions and the ability to apply them in practice.
• Excellent English written and oral communication skills.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.