Senior Clinical Trial Manager (Home Based-US or Canada)
PRA Health Sciences3.5
Remote
Job description

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities

What will you be doing?

Joining a well-established yet expanding team fully outsourced to one of our global pharmaceutical clients, the Clinical Trial Manager ensures overall successful execution of phase 1-4 clinical trials in multiple therapeutic areas, in accordance with applicable Standard Operating Procedures, agreed timelines, budgetary and regulatory requirements, at a global scale.

The Clinical Trial 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.

Reporting to a Clinical Program Leader, you will ensure accurate budget management, including guaranteeing that third-party vendors are working to defined plans.

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 Clinical Trial 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

The successful candidate will be an expert study manager, will have a proven record of successful execution of clinical trials on a global study. You will be able to work to key metrics and motivate a regionally-based study team throughout the project lifecycle. Your experience in the set-up and management of third-party vendors, as well as global study start up, will be self-evident. Familiarity with phase 1-4 studies would be highly advantageous. Demonstrable knowledge of effective project planning, strong financial acumen, along with the flexibility to manage a virtual team will ensure success within this position.

Previous experience of working with multiple therapeutic areas, including cardiology/metabolism, infectious disease, immunology and/or vaccines is preferred.

Candidates from either a pharmaceutical or CRO background are welcome to apply.

BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).

  • Candidates from either a pharmaceutical or CRO background are welcome to apply.

Willing to travel up to 20%
  • To qualify, applicants must be legally authorized to work in the United States or Canada, and should not require, now or in the future, sponsorship for employment visa status.

Benefits of Working in ICON:


Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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Company details

Headquarters

Headquarters 4130 ParkLake Avenue - Suite 400 Raleigh, North Carolina 27612 United States

Employee

10000+

Revenue

$1B to $5B (USD)

Industry

Health Care

Company Description
PRA Health Sciences has been acquired by ICON plc, creating the world’s most advanced healthcare intelligence and clinical research organization. ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently operates from 77 locations in 38 countries and has approximately 11,700 employees. Further information is available at www.iconplc.com and http://careers.iconplc.com/.
Company ratings
  • Overall
    3.5
  • Company & Benefits
    3.5 / 5
  • Culture & Values
    3.3 / 5
  • Career Opportunities
    3.0 / 5
  • Work/Life Balance
    3.5 / 5
  • Senior Management
    3.0 / 5
Company reviews
"A great company to work with"
Former EmployeeClinical Research Associate
I enjoyed working at PRA. The managers are helpful and have good work ethics. Although I disagree with the opinion of the HR policies for job termination, I respect the decision and appreciate the help and assistance of the immediate supervisors. I would recommend my friends to work with PRA to enhance their knowledge and professional carrier goals since the zero-tolerance policy related to work ethics and keeping up with the current industry rules and guidelines along with subject knowledge puts the employees among the high performers' list.

"Great training, laser focus on process"
Former EmployeeCRA
It’s a great place to learn how things should be done. However the laser focus on process kills innovation in this ever evolving field. Advice to leadership

"Amazing workplace, little growth. "
Former EmployeeResearch Associate
Working at PRA was fun! You meet a lot of great people and you get a lot of downtime. This is an amazing job if you're in school. It's very repetitive work. You always get stuck with extra work when people call in. Which kind of leads to no break.

"Nice place to work"
Current EmployeeProject Manager
Pros: I work exclusively with the client which is a big pharma company so no interaction with icon colleagues . Cons: too new to tell but in overall I can say that work environment is not bad.