Clinical Coding Manager

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview:

This position is part of the Data Management Oncology organization and supports the accurate and timely coding of medical and medication terms in clinical trial data systems, including Rave Coder. The Clinical Coding Manager is responsible for helping ensure coding quality, data integrity, and regulatory compliance across oncology clinical trials. This role works closely with Clinical Data Managers, medical reviewers, clinical teams, and other cross-functional stakeholders to clarify verbatim terms, resolve coding issues, support dictionary-related activities, and maintain coding documentation in accordance with SMPA standards and applicable SOPs. This position reports to Associate Director, Data Management.

Essential Functions Required for Job

- Serve as the Subject Matter Expert (SME) and functional lead for Clinical Coding across clinical development programs, providing strategic oversight and governance for all coding-related activities.
- Establish, maintain, and drive consistent coding standards, conventions, and best practices across studies, programs, and therapeutic areas, ensuring alignment with regulatory requirements, industry standards, and organizational expectations.
- Act as the primary authority and decision-maker for coding-related matters, including coding conventions, dictionary application, coding governance, and resolution of complex coding scenarios.
- Lead and oversee adverse events, medical history and medication coding activities within Coder Tool utilizing MedDRA and WHO Drug dictionaries, ensuring accurate, high-quality, and consistent coding outcomes across studies.
- Review, adjudicate, and make final coding determinations for complex, ambiguous, or escalated coding terms, providing expert guidance to study teams and cross-functional stakeholders.
- Drive cross-study consistency by identifying and implementing standardized coding approaches, maintaining coding governance, and ensuring alignment across clinical programs.
- Partner with Clinical Data Management, Clinical Operations, Safety, Biostatistics, Medical, and other stakeholders to establish coding strategies and resolve coding-related challenges impacting study execution and data quality.
- Own the development, maintenance, and approval of coding guidelines, conventions, standards, decision logs, and related documentation to ensure consistency and inspection readiness across programs.
- Provide expert leadership for coding activities supporting study startup, conduct, data review, reconciliation, and database lock activities.
- Lead the review and approval of coding outputs and reconciliation activities, ensuring adherence to established standards and quality expectations.
- Monitor coding quality metrics and trends, identify opportunities for process improvements and standardization, and implement corrective and preventive actions as needed.
- Serve as the business lead for coding-related system implementations, validation activities, user acceptance testing, dictionary updates, coding module enhancements, and integration initiatives.
- Develop, lead, and deliver training programs on coding standards, conventions, and best practices for Data Management and other functional groups, ensuring organizational consistency and capability development in clinical coding.
- Mentor and provide guidance to Data Managers and cross-functional team members on coding processes, standards, and governance.
- Ensure compliance with applicable regulatory requirements, company procedures, Data Management standards, and coding governance frameworks.
- Support global, multi-site clinical studies by providing clinical coding leadership and ensuring consistent application of coding practices across all study teams and programs.
- Perform other duties as assigned

Knowledge, Skills and Abilities (general & technical):

- Strong understanding of clinical trial data standards, medical coding practices, data integrity principles, and regulatory requirements.
- Proficiency with Rave Coder and familiarity with MedDRA and WHO Drug dictionaries.
- Knowledge of ICH, Good Clinical Practice, FDA regulations, and relevant Data Management standards.
- Excellent attention to detail and accuracy when reviewing verbatim terms, coding decisions, coding listings, and documentation.
- Ability to manage multiple coding tasks, timelines, and priorities in a fast-paced clinical trial environment.
- Strong communication skills for collaboration with Clinical Data Managers, CRAs, medical reviewers, clinical teams, and other stakeholders.
- Results-driven approach with initiative, ownership, follow-through, and accountability for assigned work.
- Strong organizational and time-management skills, including ability to track issues through resolution and maintain inspection-ready documentation.
- Ability to identify trends, quality signals, recurring coding issues, and areas for improvement.
- Good interpersonal, written, and verbal communication skills.

Education & Experience Requirements:

- Bachelor's degree in Life Sciences, Health Information Management, clinical research, or a related field required.
- Minimum 5 Years of Clinical trial experience, with at least 2 years of clinical data coding experience required; experience in oncology clinical trials preferred.
- Experience using Rave Coder, MedDRA, and WHO Drug dictionaries preferred.
- Experience supporting coding activities for global, multi-site clinical studies preferred.
- Preferred qualifications include experience with coding conventions, coding quality checks, dictionary updates, clinical data review processes, and coding-related documentation.

Other Requirements (licenses, certifications, specialized training, and physical or mental abilities required):

- No specific license required. MedDRA, WHO Drug, clinical coding, clinical data management, or GCP-related training is preferred.
- Ability to work on a computer for extended periods of time.
- Requires close vision for computer usage and detailed review of coding listings and clinical data.
- Requires ability to exercise appropriate judgment, maintain accuracy, and manage multiple tasks independently.

Travel Requirements:

- Ability to travel as needed, including periodic business meetings, training, or other SMPA-related meetings.

Mental/Physical Requirements:

- Primarily computer-based role requiring ability to use a personal computer for extended periods of time.
- Regularly required to sit for long periods of time and occasionally stand and walk.
- Regularly required to use hands to operate a computer and other office equipment.
- Fast-paced environment handling multiple coding tasks and timelines. Must be able to exercise appropriate judgment, maintain attention to detail, and communicate clearly.

People Management

- This is an individual contributor role and does not have direct reports or formal people-management responsibilities.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

The base salary range for this role is

$118,500.00 - $148,100.00

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, overtime, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes up to 120 hours of vacation per year, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter and access to our service recognition program.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law .

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected] . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.