Senior Clinical Project Manager in Raleigh, North Carolina, United States

Job Information

Sumitomo Pharma Senior Clinical Project Manager in Raleigh, North Carolina

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .

Job Overview

Responsible for the planning, implementation, execution and management of multiple clinical studies and/or global studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations (CRO) if applicable.

Job Duties and Responsibilities

Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines.
Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company.
Provides oversight and management of CROs, consultants and vendors.
Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
Monitors the status of clinical data collection of assigned clinical trials.
Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
Prepares and reviews study-related documents when required.
Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations 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.
Reviews correspondences and monitoring reports relating to the studies.
Prepare and deliver program/study updates.
Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team.
Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
Provides input into contracts, work orders and/or change orders.
Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
Ensures assigned studies adhere to all applicable regulations and requirements.
Provides input as the subject matter expert for the assigned studies during regulatory inspections.
Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
Evaluate CRO and vendor performance and support the improvement initiatives.
Participate in the preparation, review, updating and training of SOPs.
Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
May Mentor other team members.
Perform other duties as requested by the senior management.

Key Core Competencies

Proven leadership skills, executive presence, maturity, emotional intelligence, and 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 experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
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

S./M.S./Ph.D. in a related life science discipline is preferred.
Thorough understanding of the oncology arena.
Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.

The base salary range for this role is $137,100 to $171,500. 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 (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEO is the Law Poster Supplement

Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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

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Sumitomo Pharma Senior Clinical Project Manager in Raleigh, North Carolina

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