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Clinical Team Lead

Covance 6/20/2018 5:29:06 AM
JOB ID: 21383 Category: Clinical Operations
Boston, Massachusetts

   

 

Job Overview

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.

Education/Qualifications

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.

Preferred:

- Experience as a Senior Clinical Research Associate with on-site monitoring Experience , whether internal or external.

Experience

* 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.

Preferred:

* 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 .


Position Type: Full-Time

Location: Boston, MA - Massachusetts



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).