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About the role
Key responsibilities & impact- Manage single and multi-service projects, ensuring quality deliverables on time
- Provide expert skills as part of a Clinical Data Management (CDM) team
- Serve as internal or external point of contact on standalone coding studies or accounts
- Maintain post-coding dictionary up-versioning synonym and coding reconciliation
- Perform Dictionary up-versioning activities
- Perform external verbatim coding of data from non-EDC sources
- Perform comprehensive quality control procedures
- Perform Serious Adverse Event (SAE) coding reconciliation activities
- Collaborate with customers and develop solutions and action plans for issues
- Proactively identify, solve quality issues and deliver projects as per agreed timeline
- Identify and implement processes and quality improvement initiatives
- Provide review and expert opinion in developing, revising, and maintaining standard operating procedures
- Develop and maintain good communications and working relationships with the CDM team and client stakeholders
Requirements
What you’ll need- High School Diploma or equivalent
- Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent
- 3/4 years of relevant experience in clinical trials within a similar function
- Proven competence in managing the delivery of coding or/and other data management processes for multiple global projects
- 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
- Advanced knowledge of data management processes and systems
- Excellent understanding of clinical drug development process
- Good project management skills related to all phases of clinical studies
- Excellent knowledge of operating procedures and work instructions
- Excellent English written and oral communication skills.
Benefits
Comp & perks- Health insurance
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
codingdata managementquality controlthesaurus managementMedical DictionariesMedDRAWHODDICD9medical terminologypharmacology
Soft Skills
project managementcommunicationproblem-solvingcollaborationcustomer negotiationquality improvementrelationship managementexpert opinionsolution developmenttimeliness
Certifications
High School DiplomaPharmacy qualificationDental qualificationMedical qualificationNursing qualificationLife sciences qualification