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Clinical Trial Manager

at ICON Clinical Research in Dover, Delaware, United States

Job Description

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.

The Role:

Achieves successful delivery of operational activities (study start up, site management, clinical monitoring, and/or data review) by meeting internal and external client requirements. Oversees the management of study sites to ensure compliance with the protocol, ICH-GCP, other relevant guidelines (such as ISPE GPP) and applicable regulations, as well as SOPs. Contributes to business development activities by participating in proposals and bid defenses as required. May function in a project management role with mentoring and supervision.

+ Recognize, exemplify and adhere to ICON’s values which centre on our commitment to People, Clients and Performance.

+ As a Professional, the employee is expected to recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs.

+ Participate in opportunities for process improvement. Lead or participate in process improvement initiatives, as assigned, and promote the sharing of best practices.

+ Travel (approximately 25%) domestic and/or international.

+ Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders.

+ Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; IP management, timely investigator payments.

+ Responsible for driving enrolment as per contracted timelines.

+ Regular oversight of key clinical metrics including but not limited to: Days on Site (DOS), Monitoring Visit Report (MVR) and Follow up Letters (FUL) timelines, Action Items (AI) and other quality metrics, to ensure they are met and followed-up as necessary.

+ Oversight of visit report review and approval, including site issue escalation and resolution. This may involve direct review/approval of site visit reports, and interacting with the Central Visit Report Approvers, as appropriate.

+ Ensure clinical data is entered into the ICON CTMS or any other CTMS in a timely and accurate manner.

+ Contribute to the development and maintenance of all clinical elements of cross functional project plans.

+ Able to work on multinational studies and may take the role of a Global CTM if appropriate.

+ Responsible for coordinating and managing the clinical project team to ensure:

o high performance and productivity (e.g. DOS for CRAs)

o optimal utilization

o minimal turnover

o all necessary project training is provided, documented and filed appropriately.

+ Responsible for documenting clinical risks and developing mitigation strategies and associated action plans, including issue escalation and resolution.

+ Responsible for the development and maintenance of operational plans for clinical deliverables e.g. CRF completion guideline, Monitoring Plan, Recruitment Plan, Clinical Training Plan, annotated trip report etc.

+ Ensure the core clinical portions of the Trial Master File (electronic or paper TMF) are up-to-date and maintained in accordance with SOPs and the File Master Plan (FMP), including involvement in archiving as necessary. This includes documented QC checks of in house investigator site files.

+ Ensure all close-out activities are completed as necessary e.g. End of Trial (EOT) notifications sent, all payments made, CTMS updated, all visit reports finalized and all action items resolved.

+ Lead and/or actively participate in the conduct of clinical team meetings.

+ Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables.

+ Implement QC activities, ensure compliance with quality measures and monitor required quality metrics.

+ Maintain confidentiality of information, as appropriate.

+ Participate in business development activities such as bid defense meetings

+ May be required to undertake individual, finite PM tasks under supervision and with support of the Line Manager.

+ Participate in Company/Departmental initiatives, as requested.

+ Undertake other reasonably related duties as assigned.

To be successful in the role, you will have:

+ 4 year degree or equivalent combination of education & experience

+ 3+ years clinical research experience including site monitoring and management of study sites from start-up through close-out

+ Previous experience working on large multi-country studies in a similar role

+ Ability to travel up to 20%

+ Fluent in local language – both written & verbal

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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 through the form below.

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Job Posting: JC228628356

Posted On: Nov 16, 2022

Updated On: Jan 12, 2023

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