Covance Clinical Team Lead in San Diego, California
The Clinical Team Lead (CTL) is the leader for the clinical team in our Clinical Operations ONCOLOGY CTL group. The Clinical Team Lead is a member of the Core Project Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project. The CTL is responsible for coordinating and managing the clinical operations team (functional oversight for CRAs and CRAssts), providing operational leadership and expertise to ensure successful execution of the clinical operations project deliverables (quality, timeline, budget and scope).
This position can be field based anywhere within the United States or Canada.
This role involves regular and proactive communication with the Sponsor, the Project Manager/Project Director and other functional groups, as appropriate. The CTL will serve as the main site monitoring and site management contact and support for the Project Manager and the client.
With state-of-the-art Clinical Research Units, Covance has helped hundreds of drug development company’s progress their compounds from preclinical to proof-of-concept studies. Each Clinical Research Unit has a dedicated team of professionals, including physicians, scientists, project managers, nurses and recruiters - whose mission it is to bring the miracles of medicine to market sooner.
Additional Job Requirements Include but not limited to:
•Responsible and accountable for the clinical operations budget for the project.
•Responsible and accountable for managing the clinical operations timelines as agreed with the client.
•Participates in internal project review meetings.
•Liaise with Sponsor and Covance Regulatory Submissions.
•Coordinates and oversees IRB/IEC/regulatory document collection, processing and maintenance activities.
•Responsible and accountable for study specific revision and maintenance of Monitoring Plan, Resource Management Plan for Clinical Operations, and Training Plan for Clinical Operations.
•Responsible for the clinical management of approved sub-CROs.
Bachelor’s Degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
Thorough understanding of the drug development process.
•Experience as a Senior Clinical Research Associate with on-site monitoring experience, whether internal or external.
Minimum of five (5) years of relevant clinical research experience, preferably at a CRO, with an ability to demonstrate comprehensive understanding of: ICH/GCP guidelines, Serious Adverse Event (SAE) reporting
In lieu of the above requirements, candidates with > two (2) years supervisory experience in a health care setting and four (4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered.
1+ year’s additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
Local project coordination and/or project management experience.
Job Number 2018-21383
Job Category Clinical Operations
Position Type Full-Time
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