Experience:
1-3 years of experience
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Employment Type:
Full time
Posted:
2/5/2020
Job Category:
Research
FSP - Clinical Research Manager - Oncology ( Project...
(This job is no longer available)
Covance | Dallas, TX
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Job Description

Job Overview:

Clinical Research Manager

Remote based anywhere in the US.

Why settle for one thing when you can have everything?

Covance gives you the best two-for-one opportunity for career growth. Who doesn't want twice the perks? Working at Covance-one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!

As a Covance employee dedicated to an FSP project, you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance, Covance has an FSP opportunity to match your area of expertise.

You will enjoy the best of both worlds-all the benefits that come along with Covance's Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through.

Covance's FSP model is flexible and scalable. Our teams are collaborative and proactive - a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research.

Covance's reach is global - extending to 60+ countries making us one of the largest FSP CROs. No matter where you are located on the globe, we have an FSP opportunity for you.

The Clinical Research Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operations level in compliance with ICH GCP and country regulations.

The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during the study.

* Significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent Client with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.
* Requires ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director or Therapeutic Director. Requires strong understanding of local regulatory environment, country regulations, client policies and procedures, quality standards.
* Strong scientific and clinical research knowledge is required for this position. A strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. Requires skills to effectively build and maintain professional relationships with investigators and other external stakeholders, requiring strong communication, educational/pedagogic, diplomatic and empathic skills. The role will require proven ability to collaborate and lead high performing cross-functional teams also in a virtual environment.
* The position requires strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance. Oversee country commitments, compliance and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to lead across several dimensions simultaneously.
* Works collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors. Requires coordination and alignment with the regional and broader organization. Additionally, will work to build and maintain relationships with investigators and other external partners and promote Client's reputation. In collaboration with CRD, represents Client in Pharma industry issues and in seeking influence in external R&D environment.

Education/Qualifications:

* University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology

A combination of education, training, and experience will be considered in place of a college degree

Experience:

* 1-2 years of Clinical Research Project Management or Clinical Lead experience
* At least 1 year of field monitoring experience
* 1+ years of experience working in Oncology as PM or lead
* A total of at least 5 years experience working in clinical research

About Covance

Covance Inc. is a drug development services company providing a range of early-stage and late-stage product development services on a worldwide basis primarily to the pharmaceutical, biotechnology and medical device industries. The Company also provides laboratory testing services to the chemical, agrochemical and food industries. Covance maintains offices in more than 20 countries. The services it provides constitute two segments: early development services, which include preclinical services and clinical pharmacology services, and late-stage development services, which include central laboratory, clinical development, periapproval and market access services. It provides product development services on a global basis to the pharmaceutical and biotechnology industries. During the year ended December 31, 2008, the Company served in excess of 300 biopharmaceutical companies. In March 2009, it acquired Swiss Pharma Contract, a 50-bed clinical research company based in Switzerland.