Daiichi Sankyo US · 1 week ago
Clinical Study Manager, Global Clinical Operations
Basking Ridge, NJ
Full-time
Onsite
Mid, Senior Level
$134K/yr - $200K/yr
3+ years expDaiichi Sankyo US is dedicated to improving lives through innovative medicines and is seeking a Clinical Study Manager to oversee global clinical studies. The role focuses on tactical study delivery, project management, and collaboration with internal and external stakeholders to ensure successful execution of clinical trials.
Health CareTherapeuticsWellness
Responsibilities
Lead the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 clinical trials
Participate and provide expertise as a cross-functional study team member, including vendors, and liaise with other departments
Provide mentorship of more junior Operations team members
Lead vendor selection, contracting, and management to maintain study quality and compliance and adherence to scope of work within timelines and budget
Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level
Coordinate and develop materials for CRO KOMs and Investigator meetings
Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.)
Create and coordinate clinical study timelines and budgets with Global Project Management and R&D Finance to meet critical milestones and manage budgets
Responsible for continual review of study timelines and study budget
Identify, mitigate, and escalate risks per process throughout the study lifecycle
Ensure risks are appropriately logged in the risk management system
Co-develop and manage study materials, including training materials, protocols, CRFs, and study operational plans
Ensure all necessary operational materials are in place
Oversee site and monitor data cleaning metrics including EDC data entry, query resolution timeliness, and protocol deviation review
Oversee site selection, start-up, monitoring, and closeout for the trial
Triage, resolve or escalate study issues /risk mitigations to the Study Delivery Lead
Provide regular updates on study progress to key stakeholders
Identify training needs for key stakeholders as needed, e.g., study team members, vendors and ensure training is carried out
Develop training materials as necessary
Qualification
Required
Bachelor's Degree required in Life Sciences
3 or more years of relevant experience required
Experience in oversight of global clinical trials (all phases) in all stages of delivery with requisite industry training and experience required
Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO) required
Ability to travel up to 10% of the time
Preferred
Bachelor's Degree preferred in Life Sciences
Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO) preferred
CRA Experience Preferred
Time spent directly in a medical environment (e.g. as a Study Site Coordinator) preferred
Familiarity to a Japan-based organization preferred
Company
Daiichi Sankyo US
Daiichi Sankyo US is a pharmaceutical company delivering innovative research, solutions, and treatments to improve health.
10001+ employees
H1B Sponsorship
Daiichi Sankyo US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (25)
2023 (19)
2022 (12)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
Ken Keller
Chairman of the Board, President and CEO and Head of the Global Oncology Business Unit
Christopher Geloso
Senior Region Business Director - ADC Oncology at Daiichi Sankyo, Inc.
Recent News
2025-06-01
2025-02-18
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