Manager, Clinical Records Management

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

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manager, Clinical Records Management. The Manager, Clinical Records Management will work in Clinical Operations under the leadership of Clinical Records Lead or similar, playing a pivotal role in supporting all aspects of central records for clinical studies across Phase 1-4. The Manager, Clinical Records Management, provides support for issues, executes processes, and supports vendor management/system maintenance pertaining to essential records. Experience in clinical records management and understanding of relevant Good Clinical Practice (GCP) and regulatory guidelines will be essential in ensuring quality and compliance.

Job Duties and Responsibilities

• Conducts periodic quality reviews of study Trial Master Files to ensure quality, completeness and timeliness. 
• Provides central records support across at the study level, including Operational Study Team cross-functional team members, study sites, CROs and other vendors. ​
• Draft documents/plans for clinical records management in line with GCP and regulations.​
• Provides input into study essential records set-up, maintenance, and completeness for inspection readiness, providing records for inspection, as necessary.  ​
• Supports migration and/or transfer of essential records from vendors (sites as necessary) in collaboration with cross-functional team members for final indexing and long-term archive. ​
• Supports implementation, maintenance and decommissioning of central records systems when applicable.​
• Works in collaboration with cross-functions, Operational Study Team, CROs and other vendors on quality and compliance activities related to essential records in identifying and mitigating risk to clinical program. ​
• May support set-up and training of study personnel, CROs and other vendors to access central records systems (as necessary).​
• May contribute to development and improvement of organizational policies and procedures ​

Key Core Competencies

• Demonstrated understanding of Trial Master File structure and TMF systems
• Experienced in problem-solving, teamwork, communication skills
• Ability to collaborate with cross functional teams in document compliance
• Able to support training and delivery of guidance on TMF standards
• Experience in relevant regulatory requirements
• Experience working with vendors
• Able to support regulatory inspections and inspections
• Able to assist in implementation of process improvements

Education and Experience

• Bachelor's or advanced degree, preferably in life sciences, pharmacy, or a related field.
• Minimum 6 – 8 years (w/o Master’s) or 4 – 6 years (with Master’s) of relevant experience in biotech or pharmaceutical industry

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.

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.

Mental/Physical Requirements: Fast paced environment handling multiple demands. 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.

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.