Lead 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:

Provide the technical data management leadership on a large / global project, or multiple projects with responsibility for the Thesaurus Management System, 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 medical coding aspects of project delivery. Responsible for operational delivery and project management of a team of medical coding staff.

Summary of Responsibilities:

• Assist manager with the selection, hiring, training, development, and performance management for a team of staff within medical coding.
• Assign tasks and responsibilities within coding to team members, in a manner that - optimizes team capability; delivers timely and accurate results; and supports the needs of the business.
• Mentor coding staff and aide in staff development, career development, interpersonal skills, and achievement of competency standards.
• Serve as the technical leader on all coding aspects of project(s) including startup, maintenance, and completion activities.
• Ensure completion of Fortrea Data Management Systems Configuration Document that will implement accurate, timely, consistent, and quality medical coded data.
• 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, cycle time, and productivity metrics.
• 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, Technical Services Group, 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.
• Maintain technical competencies via participation in internal and external training seminars.
• Support global project staff on achieving client satisfaction (internal and external) through delivery of quality medical coded data, on-time and on-budget.
• Participate in the identification of areas for process and efficiency improvement and implement solutions on assigned projects.
• Assist in completing dictionary up versioning tasks.
• Assist with Medical coded data reviews. Provide oversight on coding KPI metrics.
• Assist with the performance 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 data manager for a potential change order.
• Review updates to standard templates impacting dictionary coding as a subject matter expert.
• Assist with the dictionary loading and verification of Fortrea standard dictionaries and client dictionaries are performed as necessary in a timely manner.
• Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary with direction from manager.
• Support business development for medical coding time and cost estimates and prepare and present to potential clients on global data management capabilities, if requested.
• Review literature and research technologies/procedures for improving global thesaurus management practices.
• Perform other duties as assigned by management.

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.
• Fluent in English, both written and verbal.

Experience (Minimum Required):

• Minimum seven (7) years relevant work experience in data management medical coding experience with approximately one (1) year supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
• Medical coding experience with in-depth knowledge of medical coding processes and various coding tools (e.g., Medidata Coder, Central Coding, etc.).
• In-depth knowledge of and experience with the dictionary up versioning process.
• In-depth knowledge of standard MedDRA queries (SMQ) and standard drug groupings (SDG) · Demonstrated skill for mentoring staff on technical coding competency.
• Excellent oral and written communication and presentation skills.
• 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.
• Working knowledge of tracking of staff productivity and quality metrics.
• 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 managerial and interpersonal skills.
• Broad knowledge of thesaurus management process.
• Thorough knowledge of Standard Coding Dictionaries.
• Thorough 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.
• Basic understanding of time and cost development and pricing strategies.

Preferred Qualifications Include:

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

Physical Demands/Work Environment:

• Role is office-based/remote-based, with associated risks of repetitive strain injury (associated with keyboard operation) and eye strain (associated with VDU screen operation).

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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