Lead, Clinical Trials Operations (Virtual Opportunity) in Marlborough, MA at Quest Diagnostics

Date Posted: 8/26/2019

Job Snapshot

Job Description

Patients and Physicians rely on our diagnostic testing, information and services to help them make better healthcare decisions. These are often serious decisions with far reaching consequences, and require sensitivity, tact and a clear dedication to service. It’s about providing clarity and hope.

As a Clinical Trials Operations Lead, you will work for the world leader in the industry, with a career where you can expand your skills and knowledge. You can act with professionalism, you can inspire colleagues, and you can care about the work we do and the people we serve.

Basic Purpose:

The Information Ventures' Clinical Trials Operations Lead will be responsible and accountable for the customer-focused management of Clinical Trials Connect deliverables within the assigned projects or programs.   The Lead is responsible for coordinating the execution of clinical trial projects including managing the scope, timeline and budget of assigned projects. This professional will have indirect management responsibility of team members supporting clinical trials projects and may also have direct line management responsibility of junior level project management team members.   

Duties and Responsibilities:

  • Develops and maintains strategic relationships with customers in alignment with his/her assigned projects. May collaborate with business leads for business development, alliance management, contracts and proposals development, project management, to achieve project goals. 

  • Leverages the sponsor’s patient profile (inclusion/exclusion criteria, demographics and other factors) to assess Quest’s datasets and network to develop patient and physician outreach proposals, as well as approaches to drive participation and engagement in trials.

  • Has responsibility for tracking and reporting of program metrics and management of all recruitment campaigns to ensure individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.

  • Leads the design/development of all materials required to implement assigned patient recruitment and physician engagement projects. This includes advertisements, e-mail and direct mail letters, patient education materials, physician communication plans, etc.

  • Communicates with client to provide timely project updates and project related fiscal information.

  • Works with management team to provide business analysis and support the development of presentations for both internal and external audiences. Ensures accurate and timely data is available for strategic decisions.

  • Coordinates with scientific and technical directors as required for assigned projects.

  • Responsible for identifying, tracking and managing risks that may impact our ability to successfully complete the scope of the project in the timeline or budget available.

  • Leads in the identification and resolution of service level issues, as well as the proactive development of contingency plans to mitigate laboratory risk.

  • Leads problem solving and resolution efforts in a timely, customer-focused manner.

  • Ensures lessons learned are shared and improvements are included in the proposal design process.

  • Collaborates with other departments within the company where needed to support milestone achievement and to manage study issues and obstacles.

  • Monitors billing for assigned projects. 

  • Maintains official project records from inception to completion including archiving.

  • Ensure that contracted work is conducted within regulatory requirements (FDA, EMEA).

Supervision Exercised:
May have direct line management responsibility of junior level project management team members.   

Qualifications:
Education Preferred: Bachelor’s degree in the life sciences, marketing, communications, business administration, or related discipline.  


Work Experience:

  • 5+ years CRO or pharmaceutical industry experience 

  • 3+ years of experience working in patient recruitment, clinical trials, and/or advertising environment.  

  • Relevant experience in application of GCP, FDA, and ICH guidelines

  • 3+ years of demonstrated Project Management skills 

  • Experience in management of service providers

Capabilities:

  • In-depth knowledge and application of GCP, FDA, and ICH guidelines. As well as mastery of clinical research terminology 

  • Demonstrated success with building trust and strong relationships with others; follows through on commitments

  • Strong critical thinking and problem solving skills: involves the right stakeholders; asks the right questions; understands the interrelationships of variables; utilizes data, analytics, and other key inputs to make decisions; anticipates the impact of decisions to the business and people.

  • Demonstrated proficiency with Microsoft Office suite of products, particularly Power Point, Word and Excel.  

  • Ability to prepare and persuasively present clear and concise written communications, both in report and presentation formats.

  • Demonstrated ability to work through ambiguity, prioritizing effort and resources accordingly; flex and establish balance between tactical and strategic priorities.

  • Demonstrated success as project leader with the ability to manage multiple projects simultaneously and achieve identified deliverables.

  • Utilizes creative approaches towards continuous improvement.

  • Demonstrated ability to communicate effectively with colleagues at all levels within the organization.

  • Demonstrated success with getting results and adding organizational value in a fast-pace, change-oriented environment.

  • Ability to travel via all methods of travel approximately 25%

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