Clinical Study Manager

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?

As a Clinical Study Manager, you will manage the execution of clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP) in support of the Integrated Global Development Plan (IGDP).  Leadership of the cross functional Study Execution Team (SET), including Strategic Partners and other vendors, to ensure study objectives are met, on time and within budget. Responsible for providing study level updates, including timelines & budget,  to the cross-functional Clinical Program Team (CPT) ensuring that any study issues, with proposed solutions, are escalated to the CPT, as appropriate.  Management of the study budget, including Task Orders, Change Orders, invoice approval and financial reconciliation process.

• Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP).
• Lead cross functional Study Execution Team, including functions, Strategic Partners and other vendors to ensure study goals are met, on time and within budget. Includes leading and organizing cross functional study team meetings.
• Ensure appropriate regional input for global or multinational studies prior to decision making. Responsible for communication of study information to Clinical Operations regions.
• Contributes to protocol synopsis development and to Clinical Study Plan development, including Clinical Operations feasibility assessments.
• Leads the cross functional protocol development process, including responsibility for any protocol amendments or administrative changes.
• Management of Strategic Partners, including setting expectations, training, CRO Oversight process, Task Orders, Change Orders, invoice approval and financial reconciliation process for assigned study. Responsible as first point of contact for Issue Management process for assigned study. (Range:  $750,000 (e.g. less complex  Phase 1) to $250 million(large complex outcomes studies))
• Leads the evaluation and selection of required vendors, including contract and budget negotiation, invoice approval and financial reconciliation process. Responsible for day-to-day management of vendors working on assigned study, including setting expectations, training, managing timelines and deliverables, and issue management. Provides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report.
• Escalates medical issues to appropriate medical personnel.
• Provides regular budget updates to Clinical Program Manager, or Finance when required.
• In collaboration with Study Execution Team (Strategic Partners, and vendors), identify risks to study and suggest risk mitigation plans, with oversight of Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.

What do you need to have?

Education:  Bachelors Degree, RN, or international equivalent required, Life Sciences preferred.

Skills: 

• Good understanding of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.

• Solid teamwork, organizational, interpersonal, and problem solving skills; exercises good judgment with respect to confidential information and strategies
• Fluent business English (oral and written) and basic medical writing skills

Experience: Minimum of 3 years of experience in clinical research in the pharmaceutical industry or clinical research organization.  CRA experience and protocol writing/study design experience preferred.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’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 programs. In 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 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.