|The Clinical Team Lead (CTL) is the pioneer for the clinical group in our Clinical Operations Early Clinical and Phase II-IV gathering. The Clinical Team Lead is an individual from the Core Project|
|P.S. Type: Full time||US-PA-King of Prussia||vacancy:Undefined|
The Clinical Team Lead (CTL) is the pioneer for the clinical group in our Clinical Operations Early Clinical and Phase II-IV gathering. The Clinical Team Lead is an individual from the Core Project Team and has by and large obligation and responsibility for the execution of the clinical tasks methodology of the venture.
The CTL is in charge of planning and dealing with the clinical activities group (useful oversight for CRAs and CRA Assistants), giving operational authority and ability to guarantee effective execution of the clinical tasks venture expectations (quality, course of events, spending plan and extension).
This job includes customary and proactive correspondence with the Sponsor, the Project Manager/Project Director and other practical gatherings, as fitting. The CTL will fill in as the fundamental site observing and site the board contact and backing for the Project Manager and the customer.
With best in class Clinical Research Units, Covance has helped many medication advancement organization’s advancement their mixes from preclinical to evidence of-idea ponders. Each Clinical Research Unit has a devoted group of experts, including doctors, researchers, venture administrators, attendants and selection representatives – whose mission it is to offer the supernatural occurrences of medication for sale to the public 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.
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