Manager, Clinical Records Management

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. 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.

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.
• Drafts 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

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.

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.

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 reasonableaccomodations@us.sumitomo-pharma.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.

Our Mission: To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide.

Our Vision: For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas.