Senior Coding Specialist

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Job Overview:

Assisting with the data management leadership on a large / global project, or multiple projects with responsibility for the Thesaurus Management; and technical oversight of all dictionary coding activities for the delivery of medical coded data according to client quality and integrity specifications, and project timelines and budgets. Develop and maintain a close liaison with project client contacts, core team members, and Clinical Data Managers to drive the data management aspects of project delivery.

Summary of Responsibilities:

• Assist in the supervision, mentor and evaluate medical coding services group staff and support staff development, career development, interpersonal skills, and achievement of competency standards.
• Serve as the technical leader on all coding aspects for assigned project(s) including start-up, maintenance, and completion activities.
• Assist with the identification and implementation of solutions to project data management coding issues and concerns, including proactive prevention strategies based on metrics and forecasts.
• Serve as the project and client liaison including provision of project specific coding status.
• Assist in review of Data management plan (wherever coding sections are applicable) and/or
• Study specific Dictionary Coding Conventions and Specifications.
• Interact and collaborate with other project and specialty team members (clinical, programming, statistics, Clinical Data Management, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality of coded clinical data.
• Assist in development and implementation of global SOPs and Work Instructions within functional area; liaise with other disciplines in the development of SOPs that impact functional area.
• Assist in oversight of the technical performance of the locally based coding team on achieving client satisfaction through delivery of quality medical coded data, on-time, and on-budget.
• Assist in completing dictionary up versioning tasks.
• Assist with Medical coded data reviews.
• Assist with coding KPI metrics.
• Maintain technical competencies via participation in internal and external training seminars.
• Support locally based project staff on achieving client satisfaction (internal and external) through delivery of quality medical coded data, on-time, and on-budget.
• Ensure locally based project staff are trained and adhere to project-specific, global, standardized data management processes.
• Assist in identifying areas for process and efficiency improvement and implement solutions on assigned projects.
• Support with the performance of local function review of projects regarding the dictionary management area and ensure that issues are highlighted and resolved, and that potential tasks outside the scope of the contract are identified to the coding manager for a potential change order.
• Assist with the dictionary loading and verification of Fortrea standard dictionaries and client dictionaries are performed as necessary in a timely manner.
• Review literature and research technologies/procedures for improving global thesaurus management practices.
• All other duties as needed or assigned

Qualifications (Minimum Required):

• University / college degree (life sciences, health sciences, information technology or related subjects preferred).
• Experience and/or education plus relevant work experience, equating to a Bachelor’ s degree will be accepted in lieu of a bachelor’s degree.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.

Experience (Minimum Required):

• Minimum four (4-5) years relevant work experience in data management and Clinical Data Coding experience.
• In-depth knowledge of medical coding process and various coding tools (e.g., Medidata Coder, Central Coding, etc.,).
• Excellent oral and written communication and presentation skills.
• Demonstrated ability to mentor staff on technical coding competency; in-depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
• Ability to lead teams, by example, on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
• Demonstrated interpersonal skills.
• Broad knowledge of thesaurus management process.
• Thorough knowledge of Standard Coding Dictionaries.
• Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to medical coding of clinical data.
• Knowledge of effective clinical data management practices.

Preferred Qualifications Include:

• MedDRA Certified.
• Knowledge of Fortrea and the overall structure of the organization.
• Thorough knowledge of Fortrea standard operating procedures and work instructions.

Physical Demands/Work Environment:

• Office or home-based work environment.
• Travel Requirements: Global % Of time:5 % Of the above that requires overnight stay: varies Travel is primarily to where: Client

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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