PRAHS

2017-42892

- | US-Remote
5 days ago
Title
Sr. Clinical Project Manager - Oncology (Home-Based)

Overview

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

 

At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

 

At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.

 

Responsibilities

Joining a well-established yet expanding team fully outsourced to one of our global pharmaceutical clients, the Senior Clinical Project Manager ensures overall successful execution of phase 1-4 clinical trials in Oncology, in accordance with applicable Standard Operating Procedures, agreed timelines, budgetary and regulatory requirements, on either a global or regional scale.

 

The Senior Clinical Project Manager serves as the leader for the Study Management Team, with ultimate responsibility for the set-up, planning and coordination of clinical trials through to study closure. Managing and tracking key study metrics to ensure adherence to project milestones, along with communicating with other departments, will form a key part of this role.

 

Other fundamental tasks include driving activity to ensure that enrolment commitments are met, whilst also checking that relevant documentation is duly updated, resolving problems, proactively managing risk and (where necessary) timely escalating issues. Clearly, the Senior Clinical Project Manager will also work in accordance with applicable health authority regulations and internal standard operating procedures. Where necessary, participation in the preparation for and conduct of Health Authority inspections and internal audits will also feature in this role.

 

Working at the very heart of the clinical trial, you will deliver appropriate training to your study team on a trial-specific basis. Additionally, you will act as a key liaison with Quality Management in order to establish a high level of quality throughout the project lifecycle.

Qualifications

Education & Credentials

 

Bachelor’s degree in a relevant scientific discipline

 

Experience

 

  • Minimum of seven years of relevant clinical trial experience in the pharmaceutical or biotech industry with at least two of those years managing clinical trial activities - Highly preferred

 

Knowledge, Skills and Abilities

  • Thorough and integrated knowledge of the clinical trial process including cross-functional handoffs and dependencies
  • Advanced skills and through knowledge in regard to all clinical operations and site management activities
  • Advanced skills in Project Management, particularly in regard to management of schedule, budget, communication, resources and quality
  • Ability to influence without authority
  • Strong communication, and negotiation skills
  • Strong leadership skills including the ability to create a sense of clear direction
  • Experience in oncology
  • Experience in global trials

Ability to travel to meetings, sites and vendors approximately 10-20%

 

 

  • Oncology experience highly preferred

 



PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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