PRAHS Clinical Trial Manager-Medical Affairs (Home-based US or Canada) in United States
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We are 20,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
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.
Experience supporting non-interventional (RWE) studies and pragmatic trials; Non-interventional space, prospective studies, retrospective chart reviews and database research program.
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
External Company Name: Pharmaceutical Research Associates, Inc
External Company URL: http://prahs.com/