Icon plc is a world-leading healthcare intelligence and clinical research organisationFrom 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 successIcon people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
Act as protocol lead (pl) on one or more clinical trials which may include the following activities:
Participate as a member on assigned cross-functional study team and serve as the main point of contact for clinical site management and monitoring functions.
Provide operational / clinical trial site management input to the key study documents including the protocol, informed consent, crfs, statistical analysis plan, and clinical study report as assignedParticipate in the clinical protocol committee as appropriate.
Create and maintain clinical trial start up documents such as the clinical monitoring planDevelop or provide clinical operations / clinical trial monitoring function input for other clinical trial start up activities, including; investigational drug supply plan, research specimen plan, crf completion guidelines and other plans and processes as appropriate.
Participate in the identification, evaluation and selection of clinical trial investigators/sites
Manage clinical trial site monitoring team metrics (i.eMonitoring frequency and trip report completion, crfs expected/outstanding, source document verification (sdv) progress, query aging, monitoring resource requirements, etc) to ensure performance maximizes efficiency, quality, ich/gcp adherence, and meets clinical trial and corporate goals.
Provide support to field cras and may assist in the initiating, monitoring and coordinating day-to-day operations of clinical trial sitesMay conduct monitoring visits including pre study, initiation, interim monitoring and close visits as needed.
If any portion of the clinical monitoring function is conducted by a cro, ensure performance meets expectations, as outlined in the cro oversight plan and/or other applicable plans, and requirements of the trial.
Facilitate information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external cro or contracted members, clinical field team, vendors, and other personnel as appropriate.
Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed.
Ensure completeness of clinical trial management system (ctms) and trial master file (tmf) for assigned studies
May assist in the preparation and follow-up of in-house and on-site sponsored quality audits, as well as, regulatory authority inspections,
Problem-solve clinical trial and related personnel resource issues.
Train, mentor, and may manage clinical research associates (dotted line), in clinical trial management processes and all applicable regulations.
Adhere to clinical operations or project specific quality documents (e.gSops, work practices, training guides), as applicable.participate in development of department processes and best practicesParticipate in the evaluation, training and refining of departmental standard operating procedures (sops) and guidelines, and the development of standard reports, templates and form
Qualifications
Education ba/bs or equivalent or any relevant and qualifying training, rn or health care professional, with at least 6 years of pharmaceutical clinical development experience or equivalent.
Qualifications
Oncology/hematology clinical trial experience, nda/bla filing experience, international clinical development experience is preferred
Experience in phase i-iii trials and cro management is preferred.
Proficiency in cfr and gcp/ich requirements, as well as experience working with european clinical trial directive is preferred
Excellent leadership, communication, and organizational skills.
Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously.
Frequently interacts with subordinate supervisors, customers or functional peer group managers and will interact with senior management.
Proficiency in microsoft office products (word, excel, powerpoint, sharepoint) and other electronic systems (ctms, edc and etmf)
Benefits of working in icon:
Our success depends on the knowledge, capabilities and quality of our peopleThat’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 programsIn 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 harassmentAll 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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