Job Description
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.
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 Pref
- 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.
- Thesaurus management experience
- 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.