Senior Clinical Trial Management Associate

Senior Clinical Trials Management Associate

Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma's 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo- ( ]

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Clinical Trial Management Associate (Sr. CTMA) located remotely. The position reports to a CTM, Sr CTM or Operations Portfolio Lead (OPL) , and is responsible for supporting the operational execution, oversight and management of one or more clinical trials from start-up through close-out. The individual provides assistance in ensuring the quality oversight of clinical service providers (CSPs).

Job Duties and Responsibilities

• Assist in protocol execution and all operational aspects on one or more clinical trials from start-up through close-out while following SOPs and ensuring compliance with country regulations and ICH/GCP guidelines.
• Assist in CRO interactions, including implementation of operational functional activities (e.g., study management, site monitoring, site management, etc.).
• Assist the study lead with CRO/CSP selection process for outsourced activities including RFP development and review, bid defense meetings, CSP performance and issue resolution.
• Serve as CSP lead or assist with management of one or more CSPs and one or more country/region on global clinical trials.
• Assist the study lead, Operations Portfolio Lead (OPL), CBO and/or finance to develop and manage CRO and other CSP contract/budgets, forecast financials for CSPs and/or overall study, reconcile invoices against accruals, ensure accuracy of work order and change order updates.
• Assist in the development of internal and external study documents/plans including, but not limited to, clinical monitoring and management, Team Charter, TMF management, protocol deviation, Screening/Enrollment closure, pharmacy manual, etc.
• Review site-level study documents (e.g., informed consent forms, study tools/worksheets, etc.).
• Review essential documents for accuracy and compliance to Standard Operating Procedures (SOPs), ICH/GCP, and applicable regulatory requirements as needed.
• Assist with the preparation of key study documents including protocols, ICFs, CRFs, Clinical Study Reports (CSR), NDA submission, as appropriate.
• Assist the study lead to develop, manage, and track study timelines against study milestones and communicate timeline risks to all internal and external stakeholders.
• Assist in preparing study status metrics and risk mitigations for senior management, as assigned.
• Able to identify potential study risks and discuss mitigation strategies/solutions with study lead.
• Generate study related slides and organize and present at internal team meetings, investigator meetings, site trainings, and other trial-specific meetings.
• Participate in the EDC and IXRS specification process, as appropriate.
• Participate in clinical data review for assigned clinical trial(s).
• May serve as subject matter expert (SME) on various company working groups and participate in the development, review and implementation of departmental SOPs and processes, as assigned.
• Actively participate in activities, as assigned, to maintain inspection readiness at all times on clinical trial(s) Assist in organizing and presenting at internal team meetings, investigator meetings, site trainings, and other trial-specific meetings.
• Manage and file documents within the Trial Master File (TMF), including conducting periodic reviews of TMF records maintained by Myovant and/or Contract Service Providers (CSPs).
• Perform some or all of the duties and responsibilities outlined for a Clinical Trial Manager Associate (CTMA), as needed.
• May be assigned other projects and duties as required.

Key Core Competencies

• Demonstrate communication, collaboration, and organizational skills with an ability to manage and influence stakeholders in a matrix environment effectively.
• Exercise good judgment and make decision that is appropriate for the organization.
• Results-driven, take initiative and ownership to accomplish work.
• Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment.
• Strive for continuous improvement and embrace innovative ideas in daily work.
• Able to work in a strong team-oriented environment and effectively develop collaborative internal and external relationships.
• Detail-oriented without losing sight of the big picture.
• Possess project management skills with ability to manage multiple projects, complex timelines and shift priorities quickly while working under tight deadlines in a team environment.
• Must have knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
• Proven project management skills and study leadership ability.
• May require occasional domestic and international travel.

Education and Experience

• Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline.
• At least 4 - 5+ years of clinical trial experience.
• Experience in management of CROs and other CSPs.
• Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials.
• Prior experience as a study coordinator or Clinical Trial Assistant preferred.
• Demonstrated proficiency in MS Office (Outlook, Word, PowerPoint and Excel) and experience with Smartsheets is a plus.
• Experience working within a small biotech company preferred.

The base salary range for this role is $77,200.00 - $101,300.00. 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 unlimited 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.

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) and Affirmative Action employer

Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All 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, gender identity or expression; 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.

For more information about EEO and the Law, please visit the following pages:

Equal Employment Opportunity is THE LAW (

EEO is the Law Poster Supplement

Pay Transparency (

Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma's 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo- ( ]

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