Clinical Study Manager — Bernards Township, NJ at

About Daiichi Sankyo

At Daiichi Sankyo, we are united by a single purpose: to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and over 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.

Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society," we are shaping a healthier, more hopeful future for patients, their families, and society.

About the Role

The Clinical Study Manager is a pivotal role responsible for the delivery and execution of global clinical studies under the direction of a Study Delivery Lead. This position is primarily focused on tactical study delivery and reports to a Director or higher-level position.

In this role, you will serve as a cross-functional leader, managing the operational aspects of planning, execution, and management for Phase 1-3 clinical trials. You will act as a liaison between internal departments and external vendors, ensuring that study quality, compliance, and timelines are maintained. The role requires a dual focus on operational strategy and hands-on study execution, involving routine interaction with key stakeholders to communicate project status, resolve issues, and troubleshoot inquiries.

You will be the guardian of study integrity, overseeing vendor selection, contracting, and performance management to ensure adherence to Daiichi Sankyo's quality measures. From coordinating materials for CRO Kick-Off Meetings and Investigator meetings to ensuring the Trial Master File is complete and accurate, you will drive the operational success of assigned studies. Additionally, you will mentor junior team members and identify training needs for the broader study team.

Hiring Process

Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Equal Opportunity

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. We are committed to fostering a diverse and inclusive workplace where everyone can contribute to our mission of improving lives globally.

Work location

Work model: On-site

316, Lyons Road, Liberty Corner, Bernards Township, Somerset County, New Jersey, 07920, United States

Bernards Township, New Jersey

Key Responsibilities

check_circleLead operational aspects of planning, execution, and management of Phase 1-3 clinical trials
check_circleManage vendor selection, contracting, and performance to ensure compliance and adherence to scope
check_circleCreate and coordinate clinical study timelines and budgets with Global Project Management
check_circleIdentify, mitigate, and escalate risks throughout the study lifecycle
check_circleCo-develop and manage study materials including protocols, CRFs, and training materials
check_circleOversee site selection, start-up, monitoring, and closeout for assigned clinical trials
check_circleEnsure compliance with GCP/ICH guidelines and regulatory requirements
check_circleProvide regular updates on study progress to key internal and external stakeholders
check_circleOversee CROs and third-party vendors to ensure quality measures and budget adherence

Requirements

verifiedBachelor's Degree in Life Sciences
verified3+ years experience
verifiedExperience in oversight of global clinical trials (all phases)
verifiedCRA experience preferred
verifiedFamiliarity with Japan-based organization preferred

Nice to Have

Bachelor's Degree in Life Sciences, CRA experience, experience spent directly in a medical environment (e.g., as a Study Site Coordinator), and familiarity with a Japan-based organization.

Skills, education and keywords

Skills: GCP, Ich, Fda, Mhra, Edc, Cra, Clinical Trials, Study Management, Vendor Management, Risk Management.

Education: Bachelor's Degree preferred in Life Sciences; BSc required.

Frequently asked questions about Clinical Study Manager, Global Clinical Operations at Daiichi Sankyo US

What does a Clinical Study Manager, Global Clinical Operations at Daiichi Sankyo US do?expand_more

Day-to-day, the Clinical Study Manager, Global Clinical Operations at Daiichi Sankyo US will lead operational aspects of planning, execution, and management of phase 1-3 clinical trials; manage vendor selection, contracting, and performance to ensure compliance and adherence to scope; create and coordinate clinical study timelines and budgets with global project management; and identify, mitigate, and escalate risks throughout the study lifecycle.

What are the requirements for this Clinical Study Manager, Global Clinical Operations role?expand_more

To qualify for the Clinical Study Manager, Global Clinical Operations at Daiichi Sankyo US position, applicants should have: Bachelor's Degree in Life Sciences; 3+ years experience; Experience in oversight of global clinical trials (all phases); CRA experience preferred; and Familiarity with Japan-based organization preferred.

Where is the Clinical Study Manager, Global Clinical Operations role at Daiichi Sankyo US located?expand_more

Clinical Study Manager, Global Clinical Operations at Daiichi Sankyo US is based in 316, Lyons Road, Liberty Corner, Bernards Township, Somerset County, New Jersey, 07920, United States. This is a on-site role.

Is this Clinical Study Manager, Global Clinical Operations job remote, hybrid, or on-site?expand_more

Daiichi Sankyo US has listed this Clinical Study Manager, Global Clinical Operations role as on-site.

How much experience is required for this Clinical Study Manager, Global Clinical Operations role?expand_more

Clinical Study Manager, Global Clinical Operations at Daiichi Sankyo US typically requires 3+ years of relevant experience at the mid level level.

What skills do you need for the Clinical Study Manager, Global Clinical Operations role at Daiichi Sankyo US?expand_more

Key skills for Clinical Study Manager, Global Clinical Operations at Daiichi Sankyo US include GCP; Ich; Fda; Mhra; Edc; Cra; Clinical Trials; and Study Management.

What education is required for Clinical Study Manager, Global Clinical Operations at Daiichi Sankyo US?expand_more

Educational requirements for this role: Bachelor's Degree preferred in Life Sciences; and BSc required.

What category does the Clinical Study Manager, Global Clinical Operations role belong to?expand_more

Clinical Study Manager, Global Clinical Operations at Daiichi Sankyo US is part of the scientific & qa job category on Recrutus.

Clinical Study Manager, Global Clinical Operations