- Lead the development of the clinical study plan and oversee critical path activities.
- Manage the creation and implementation of the cross-functional Clinical Study Oversight Plan (CSOP).
- Provide operational insights for study protocols and amendments.
- Lead document reviews, coordinate protocol-related tasks, and facilitate CRO and vendor selection processes.
- Oversee trial feasibility, site identification, budget monitoring, compliance, and risk assessment.
- Ensure trial master file completeness and inspection readiness.
- Act as the Study Team Leader when necessary, coordinating cross-functional teams and aligning with Global Clinical Leads.
- Supervise and manage CRO(s) and 3rd party vendors to ensure adherence to quality standards and timelines.
- Coordinate site initiation, monitoring visits, and study close-out activities.
- Review CRO-generated reports, track operational performance, and provide solutions for any issues.
- Liaise with internal functions and support audits and inspections.
- Facilitate training sessions and recommend areas for enhancement and innovation.
- Bachelor's Degree in Life Sciences preferred.
- 4+ years of relevant experience, including clinical operations in the industry setting.
- Experience in pharmaceutical, medical device, or research organizations preferred.
- CRA experience is a plus.
- Physical readiness for occasional domestic or global travel.
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Senior Study Manager, Global Clinical Operations - Basking Ridge, United States - Daiichi Sankyo Inc.
Description
About the Company and Job Title:
Daiichi Sankyo Group is dedicated to pioneering and delivering innovative pharmaceutical treatments to elevate healthcare standards and cater to diverse, unmet medical necessities globally. With over a century of scientific proficiency and a presence in 20+ countries, Daiichi Sankyo, along with its 15,000 employees worldwide, harnesses a rich tradition of innovation and a promising pipeline of new medications to aid individuals.
Under the Group's 2025 Vision to emerge as a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo concentrates mainly on offering groundbreaking therapies in oncology, along with research in rare diseases and immune disorders.
The incumbent will be in charge of assuring the efficient execution of clinical studies in one or more regions, following Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), FDA regulations/EU Directive, and ICH guidelines.
The Senior Clinical Study Manager will regularly engage with essential internal and external stakeholders, providing project updates, escalating issues, and addressing routine inquiries. Exceptional written and verbal communication skills, strong decision-making capabilities, clinical project management acumen, and meticulous attention to detail are imperative for this role.
Responsibilities may entail interactions with various Daiichi-Sankyo business entities, both in the U.S. and globally, as well as governmental, academic, community, and industry organizations.
The Senior Clinical Study Manager position primarily focuses on tactical study delivery, reporting to an Associate Director or higher accountable for Operational Study Strategy.
_Daiichi Sankyo, Inc. is an equal opportunity employer fostering diversity and inclusion. Job applicants are evaluated based on merit without discrimination._
At Daiichi Sankyo, Inc., we believe in recognizing individual contributions while promoting collaboration. Our supportive environment, coupled with training and technology, empowers our employees to thrive. Open communication, accountability, and a results-driven approach define our corporate culture, ensuring that each employee's distinct skills are valued and utilized effectively. Embark on a rewarding career journey with Daiichi Sankyo, Inc.
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