Associate Clinical Project Manager

sumitomopharma; United States; On-site; USD 65,000 - 95,000; Full time

Job summary

Sumitomo Pharma Co., Ltd. is seeking a Clinical Research Professional to assist the Clinical Project Manager in planning, execution, and management of multiple US-based clinical studies.

You will support day-to-day operations, coordinate with CROs, and help ensure quality data and regulatory adherence across trials. The role requires 2+ years in clinical drug development or related research, familiarity with ICH-GCP/FDA regulations, and strong communication within a matrix team.

Qualifications

• BA/BS/MS/PhD in life sciences preferred.
• Minimum 2 years in clinical drug development or equivalent.
• Knowledge of ICH-GCP and FDA requirements.

Responsibilities

• Support the CPM to design, develop, and deliver the clinical study per timelines.
• Coordinate with cross-functional teams to ensure proper execution of trials.
• Monitor data collection status for assigned trials.
• Assist with site lists and site evaluation for inclusion in studies.
• Prepare and review study plans and documents as required.
• Review CRAs/CRO documents for regulatory alignment and protocol consistency.
• Participate in study team and CRO/Vendor meetings.
• Provide program/study updates to the team.
• Coordinate delivery of clinical trial supplies with CROs and partners.
• Assist with change orders and invoice tracking.
• Mentor junior team members when appropriate.
• Perform other duties as requested.

Skills

Excellent written/oral communication

Matrix environment

Cross-functional collaboration

Attention to detail

Regulatory knowledge

Data-driven planning

Education

Bachelor's or higher in life sciences

Tools

Microsoft Word

Excel

PowerPoint

Job description

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

Responsible for assisting the Clinical Project Manager (CPM) with the planning, implementation, execution, and management of multiple clinical studies by supporting the CPM in overseeing day-to-day operations and assisting as needed with the management of outside Clinical Research Organizations.

Job Duties and Responsibilities

• Supports the CPM to design, develop, and deliver the clinical study per agreed upon timelines.
• Assists in the planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
• Monitors the status of clinical data collection of assigned clinical trials
• Assists with preparation of potential investigator site lists and assists with their evaluation for inclusion in the study
• Prepares and reviews study-related plans and documents when required
• Reviews study-related plans generated by CROs and vendors, and ensures the documents are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies
• Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required
• Participates in meetings - i.e. Study Team Meetings, Investigator Meetings, Monitors' workshops and CRO Training
• Prepares and delivers program/study updates as determined by project team
• Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members
• Supports CPM with review of change orders from CROs, vendors and investigator sites (as applicable).
• Provides input into contracts, work orders and/or change orders
• Assists with review and management of invoice tracking/reconciliation
• Ability to anticipate potential study issues and to prepare contingency plans in consultation with the CPM
• Supports the CPM to ensure assigned studies adhere to all applicable regulations and requirements
• Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates
• Identifies issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and supports implementation of solutions and mitigations in consultation with the CPM
• Participates in the preparation, review, updating and training of SOPs
• Maintains knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities
• May mentor other junior team members
• Perform other duties as requested

Key Core Competencies

• Excellent written/oral communication skills
• Demonstrated skills working within a matrix environment
• Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in parent company in Japan
• Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance
• Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
• Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems
• Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas
• Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards
• Strong analytical skills with a data driven approach to planning, executing, and problem solving
• Working knowledge of current global regulatory requirements and guidelines for clinical trials

Education and Experience

• B.A. or B.S./M.S./Ph.D. in a related life science discipline is preferred
• Minimum of 2 years of industry experience in clinical drug development or equivalent academic experience in clinical trials
• Working knowledge of clinical trial conduct and applicable regulations, including ICH-GCP and FDA requirements.
• Understanding of clinical development processes, study start-up, conduct, and closeout activities.
• Strong organizational and project coordination skills with the ability to manage multiple priorities and timelines.
• Effective verbal and written communication skills with the ability to collaborate across cross-functional teams and external partners.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint,