Sr Clinical Study Assoc CO
Not Disclosed•Full-TimeOn-site
location_on316, Lyons Road, Liberty Corner, Bernards Township, Somerset County, New Jersey, 07920, United States
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 more than 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
This position serves as a vital support pillar within Clinical Operations, assisting in the planning and execution of clinical studies under the supervision of the Study Manager. The role is designed to ensure the integrity and compliance of our trials by providing essential clinical trial management support to study teams.
In this capacity, you will act as a key liaison for tracking Contract Research Organization (CRO) and vendor performance against project goals and milestones. Your work will be critical in monitoring and ensuring compliance with the Daiichi Sankyo Clinical Study Oversight Plan (CSOP), while adhering strictly to the protocol, Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines.
Equal Opportunity
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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.
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_circleProvide clinical administrative support including meeting logistics, agendas, and minutes
- check_circleCollect information and coordinate with Regulatory Operations to post trial information on public forums
- check_circleReview and document CRO-generated reports such as site monitoring trip and protocol deviation reports
- check_circleTrack study metrics including site start-up, recruitment, regulatory documents, and TMF filing activities
- check_circleProvide tracking and oversight to vendors handling lab logistics and other appropriate vendors
- check_circleReconcile TMF document trackers with the document archive and propose remediation plans for issues
- check_circleWork with Insurance Brokers to obtain study site insurance coverage
- check_circleAnalyze study site metrics reports to identify potential areas of concern and elevate them to supervisors
- check_circleDistribute key study documents to CROs and vendors as appropriate
Requirements
- verifiedBachelor's Degree (preferred in Life Sciences)
- verified2 or more years work experience with Bachelors degree
- verifiedClinical or basic research experience in Pharmaceutical, Medical device/Diagnostic, ARO, or CRO
- verifiedCRA experience preferred
Nice to Have
Bachelor's degree in Life Sciences, CRA experience, and time spent directly in a medical environment (e.g., as a Study Site Coordinator).
Benefits & Perks
check_circleDownload Our Benefits Summary PDF
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Skills, education and keywords
Skills: Good Clinical Practices, GCP, Sop, Fda Regulations, Eu Directive, Ich Guidelines, Clinical Trial Management, Clinical Study Oversight Plan, Croom, Clinical Development.
Education: Bachelor's Degree preferred in Life Sciences.
Frequently asked questions about Sr Clinical Study Assoc CO at Daiichi Sankyo US
What does a Sr Clinical Study Assoc CO at Daiichi Sankyo US do?expand_more
A Sr Clinical Study Assoc CO at Daiichi Sankyo US is responsible for the following: Provide clinical administrative support including meeting logistics, agendas, and minutes; Collect information and coordinate with Regulatory Operations to post trial information on public forums; Review and document CRO-generated reports such as site monitoring trip and protocol deviation reports; and Track study metrics including site start-up, recruitment, regulatory documents, and TMF filing activities.
What are the requirements for this Sr Clinical Study Assoc CO role?expand_more
To qualify for the Sr Clinical Study Assoc CO at Daiichi Sankyo US position, applicants should have: Bachelor's Degree (preferred in Life Sciences); 2 or more years work experience with Bachelors degree; Clinical or basic research experience in Pharmaceutical, Medical device/Diagnostic, ARO, or CRO; and CRA experience preferred.
Where is the Sr Clinical Study Assoc CO role at Daiichi Sankyo US located?expand_more
Sr Clinical Study Assoc CO 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 Sr Clinical Study Assoc CO job remote, hybrid, or on-site?expand_more
Daiichi Sankyo US has listed this Sr Clinical Study Assoc CO role as on-site.
How much experience is required for this Sr Clinical Study Assoc CO role?expand_more
Sr Clinical Study Assoc CO at Daiichi Sankyo US typically requires 2+ years of relevant experience at the mid level level.
What skills do you need for the Sr Clinical Study Assoc CO role at Daiichi Sankyo US?expand_more
Key skills for Sr Clinical Study Assoc CO at Daiichi Sankyo US include Good Clinical Practices; GCP; Sop; Fda Regulations; Eu Directive; Ich Guidelines; Clinical Trial Management; and Clinical Study Oversight Plan.
What education is required for Sr Clinical Study Assoc CO at Daiichi Sankyo US?expand_more
Educational requirements for this role: Bachelor's Degree preferred in Life Sciences.
What category does the Sr Clinical Study Assoc CO role belong to?expand_more
Sr Clinical Study Assoc CO at Daiichi Sankyo US is part of the scientific & qa job category on Recrutus.