Manage upversioning and recoding activities and deliverables for all global clinical trials uploaded to the Global Clinical Safety Data Warehouse (GCSDW).
Represent the OPDC Data Management Department in a leadership role as a key member of the Global Medical Coding Working Group to govern global medical coding practices. Provide technical expertise to coding personnel, Data Management leads and project teams to develop and maintain consistency, accuracy and quality of data coding. Lead company initiatives as assigned.
Key Job Responsibilities:
- Collaborates with global Otsuka affiliates to manage the upversioning and recoding activities of all clinical data uploaded to the Global Clinical Safety Data Warehouse. This is inclusive of recoding for Annual IB Updates, Data Monitoring Committee meetings (DMC), Interim Analysis, and NDA and MAA submissions, if applicable.
- Serves as a key member of Global Medical Coding Working Group, representing OPDC Data Management, to establish best practices for coding clinical data and communicates decisions to applicable functional areas.
- Maintains, upversions and distributes global synonym lists for clinical data.
- Manages coding staff and provides performance feedback as applicable.
- Provides consultation, leadership, and expertise to Contract Research Organization (CRO) personnel and internal Data Management staff on coding processes.
- Maintains currency of OPDC coding guidelines, updating as necessary with input from clinical and safety team members.
- Develops standard processes to be used for coding activities.
- Establishes and maintains training documents related to coding practices.
- Works collaboratively with Information Technology on maintenance and upgrade of existing coding technology, as well as evaluating new coding applications as needed.
- Provides expert review for Testing and Validation documents (eg. User Acceptance Test) as they relate to coding activities.
- Attends MedDRA and WHO Drug User group meetings to maintain currency with industry standards and perspectives.
- Proactively identifies and implements opportunities for process improvements.
- Provides input in the development of departmental and global standard operating procedures (SOPs).
- Reviews coding listings from CROs for consistency and appropriate assignment of codes.
- Provides resolution alternatives to establishing appropriate coding, based on assessment of industry coding and research to data managers and CROs.
- Coordinates coding activities related to the review and approval of data coding listings for OPDC trials with Medical Director and Clinical Safety department.
- Reviews Data Management Plans and approves Data Coding Conventions for CROs for OPDC trials as they pertain to clinical coding.
- Serves as liaison and point of contact for coding activities with all project teams, assuring the timely completion of timeline milestones.
- Assigns appropriate codes to verbatim terms according to the appropriate dictionaries and conventions.
- Ensures consistency and accuracy of data coding across compounds.
- Manages internal coding reports.
Travel (approximately 10%)
- Bachelor's degree with a minimum 10 years of coding experience in clinical research or CRO environments as well as pharmaceutical industry experience including 3 years of supervisory experience
- Extensive knowledge and skill of coding with MedDRA and WHO Drug Dictionaries.
- Solid knowledge of medical and clinical practices with a strong understanding of medical concepts and terminology.
- Solid knowledge of applicable U.S. regulatory requirements and a complete understanding of pharmaceutical industry practices and CRO coding.
- Strong computer skills with demonstrated experience in working with the Microsoft suite of programs.
- Knows how/when to apply organizational policy or procedures to a variety of situations.
- Capacity to remain flexible, frequently re-assessing and re-prioritizing projects based on business needs.
- Strong oral and written communication and presentation skills.
- Strong interpersonal skills to manage and coordinate with internal and external users.
- Ability to exercise independent judgment in the decision making process.
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