Clinical Trial Manager-Sponsor Dedicated (Home Based-US or Canada)
Job title: Clinical Trial Manager-Sponsor Dedicated (Home Based-US or Canada)
Company: PRA Health Sciences
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.
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.
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).
Minimum of 6 years clinical trial management experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
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.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
Job date: Sat, 04 Dec 2021 04:06:35 GMT
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