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5I
5PY IQVIA RDS Inc.
Assoc Dir, Patient & Site Svcs
Career Insights for Clinical Trial Manager
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What they do
A Clinical Trial Manager is responsible for planning and managing all aspects of an organization's program of clinical trials, usually for an organization undertaking pharmacological drug testing.
$159,477 / year median in Utah
Job Description
Overview The Associate Director, Patient & Site Services plays a key role in assisting and overseeing the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, can-do attitude, the ability to manage a large team and strong interpersonal and team building skills. The Regional Manager will be responsible for coordinating efforts with other study team members in order to achieve protocol objectives and corporate goals across multiple research locations. Essential Functions Oversee the conduct of your assigned sites; responsible for the training of staff/providers, process development, point of contact for the Head of Operations Foster strong working relationships with the clinics and serve as the sponsor for clinic related activities Accountable for enrollment success at sites across all studies; understand revenue expectations Maintain a significant depth of knowledge and experience in coordinating across multiple therapeutic areas Assist in the development of the annual site roadmap Facilitate site qualification, study initiation, and monitoring visits, and study close-out activities Directing recruitment activities and fostering a team environment to facilitate growth at the site Work closely with the Quality Assurance Department to ensure quality at the site; create processes and CAPAs to improve trends. Attend training(s) on leadership, communication, and other topics to help in the management of teams, as required Conduct 1:1 meetings and annual reviews with site staff Lead team meetings and set employee expectations Supervising and/or conducting staff meetings on a regular basis to monitor progress of active clinical research trials and provide communication updates Manage multiple concurrent trials across multiple study locations Assist with mentoring and training study team members Support the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-clinical supply materials, imaging and laboratory handling manuals, etc.) Occasional participation in special project responsibilities and travel to other site locations when needs arise while still maintaining the expectation of your home site Qualifications Experience as a primary Clinical Research Coordinator on at least six studies of medium to high complexity and back-up CRC on other studies Extensive knowledge and ability to apply GCP/ICH and applicable regulatory guidelines People Management experience Superior knowledge and experience of site operations Trained in leadership, project management, and process development Excellent written and verbal communication skills. Interpersonal skills - open to others' ideas and willing to learn new things; respond well to questions and challenges Process improvement - supports ideas and theories on process improvement for efficiency and effectiveness IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.