Clinical Trials Site Lead in Lewisville, TX at Quest Diagnostics

Date Posted: 10/19/2021

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    2501 South State Highway 121
    Lewisville, TX
  • Experience:
    Not Specified
  • Date Posted:
    10/19/2021
  • Job ID:
    req67191

Job Description

Look for more than answers.

At Quest, we are on a continuous journey of discovery and development. It’s this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast-moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people.

As a Clinical Trials Site Lead, you will work for the world leader in the industry, with a career where you will have the opportunity to collaborate and affect change while expanding your leadership skills and technical knowledge.

This professional will work on-site at the Quest Diagnostics in Lewisville, TX.

Clinical Trials Site Lead, the role:

The Clinical Trials Site Lead is responsible for leading a site and or function in the execution and delivery of services in support of the biopharmaceutical and diagnostic clients. This professional will have line management responsibility for a specific team that is local to a site and/or matrix responsibility for a functional team across multiple sites. The Clinical Trials Site Lead will be responsible for developing new processes that meet industry expectations and ensuring operational compliance with existing processes, and will also have responsibility for delivering and servicing a portfolio of projects at their site and managing to the projects and the site to profitability.

The Site Lead will be a key stakeholder in pre-award discussions and budgeting, execution, closeout, and overall performance assessment of all ongoing projects across the Specialty Clinical Trials business. The Site Lead will have direct line management responsibility of junior level study management team members, as well as indirect management responsibility of team members supporting clinical trials projects.

For our Lewisville location, this professional will have significant opportunity to guide the further development of an existing LIS to support the newly formed Specialty Clinical Trials business unit.  Additionally, the Site Lead will have the opportunity to lead a team that supports a biorepository that serves internal and external customers.

Job responsibilities:

  • Lead process improvement and development for the site and communicate across sites to standardize processes and share best practices
  • Synthesize and communicate site needs and direction to upper management and lead the development of business cases, strategy and go-forward plans
  • Coordinate with scientific and technical directors for projects to ensure scientific/medical integrity of projects is upheld
  • Review contracted scope, budget and timeline to develop a plan of action or multiple plans of action to successfully complete project.
  • Manage and own P&L for the site and develop yearly financial goals with leadership team
  • Coordinate with appropriate technical staff within the laboratory operations to ensure. operational plan is achievable and appropriate resources are available for scope.
  • Coordinate with Business Development and Proposal Management throughout the life of the project to ensure scope, timeline and budget are well understood and also understand escalation path for communicating issues.
  • Manage and own client relationships for projects executed at the site of responsibility and/or for the function.
  • Assign newly awarded projects to Study Management and Data Management teams, manage workload across on site SCT team.
  • Identify, track and manage risks that may impact our ability to successfully complete the scope of the project in the timeline or budget available.
  • Identify new or out of scope requests from customer and communicate with Business Development so contract modifications can be implemented.
  • Maintain official project records from inception to completion including archiving.
  • Ensure that contracted work is conducted within regulatory requirements (FDA, EMEA, GCP).
  • Other duties as assigned.

To qualify, the ideal candidate will have the following skills and experience:

  • Bachelor’s degree required, masters or graduate degree preferred
  • 7 to 10 years of healthcare experience or equivalent education and experience
  • 5 years of previous project management experience required
  • 5 years of previous laboratory experience required
  • Previous experience in a GXP environment required
  • Excellent verbal and written communication skills.
  • Exceptional interpersonal skills and business acumen.
  • Strong organizational skills; very detail oriented and a self-motivated problem solver.
  • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
  • Ability to travel 10 – 20%. Occasional travel will be required to meet with customers, management from other clinical trial sites or attend trade shows or conferences.

Apply Today

Join us for competitive benefits and development opportunities in a progressive and supportive environment. Help us improve our service, and the experiences of our patients and colleagues. Work with us and together we can be better.

Your Quest career. Seek it out.

 

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity or Citizenship.