Senior Clinical Research Manager (In-House), Oncology

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 or follow us on LinkedIn.

The In-house Sr. Clinical Research Manager, will oversee the day-to-day functions of assigned Site Monitors (SM) to ensure the monitoring team is meeting established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

The In-house Sr. Clinical Research Manager works collaboratively with internal and external team members and supports project team activities to ensure all study deliverables are completed on time and within budget. The In-house Sr. Clinical Research Manager will oversee clinical site management performed by the Lead Clinical Research Associate (CRA) and site monitors.

Key Responsibilities:

· Supports the Director of Clinical Operations in management of Site Monitoring Team relating to regular timesheet and expense approvals.

· Assists the Director of Clinical Operations in periodic and annual budget forecasting for site monitoring across programs.

· Supports implementation of global initiatives to ensure monitoring training and conduct are consistent.

· Participates in and may facilitate cross-functional study teams, liaise with other functional areas to coordinate clinical study monitoring-related activities.

· Coordinates with study project leads on clinical study timelines to meet critical milestones; escalate monitoring-related issues that may jeopardize timelines and deliverables.

· Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.

· May review monitoring visit reports; liaise with monitors to understand any trends on quality issues or other site issues to develop solutions. Provides regular updates of study monitoring progress; proactively identifies and resolves issues that arise during study conduct; manages escalation of monitoring-related issues.

· Participates in development and review of study plans; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study documents.

· Implements appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.

· Provides oversight of monitoring-related site level TMF document collection and filing, as well as collaboration with project-specific TMF Specialist to ensure inspection readiness of the TMF.

· Contributes to study feasibility assessments and selection of countries and sites for study conduct.

· Works with Lead CRA to develop monitoring training and may conduct internal/external training sessions including investigator meetings

· All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOP's.

· Mentors' junior members of the team.

· Performs other duties as assigned.

Professional Experience/Qualifications:

· Minimum of 6 years CRA experience in the pharmaceutical/biotech industry.

· Bachelors Degree Required.

· Must have strong knowledge of ICH/GCP guidelines.

· Comprehensive understanding of the drug development process.

· Prior oncology drug development experience preferred.

· Adept at working with a cross-functional project team.

· Strong interpersonal, communication and leadership skills.

· Proficient with MS office suite.

· High level of organizational skills.

· Demonstrated ability to work independently in a matrix environment.

· Demonstrated ability to prioritize and manage multiple tasks simultaneously.

· Demonstrated ability to influence through collaboration.

· Flexibility to accommodate changes in priorities and project needs.

· This position is not an onsite monitoring position but may require travel < 10% to sites to co-monitor/train, attend Investigator meetings, conferences etc.

The base salary range for this role is $137,800 to $172,300. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, 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 flexible paid time off, 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. 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.

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.

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 or follow us on LinkedIn.

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.

SMPA may use Artificial Intelligence ("AI") as part of the job application process, including to assist us in evaluating your application. By submitting your information, you acknowledge that the company may use AI tools as part of our evaluation.

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