Senior Clinical Trial Manager

Senior Clinical Trial Manager

JR090306

Site: Mexico or Argentina / Brazil / Peru / Chile / Colombia or Peru

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Overview:

To act as the Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies. To oversee and serve as the liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical study for the delivery of all aspects of monitoring and site management, ensuring consistency with ICH/GCP and applicable ICON Standard Operating procedures (SOps), applicable regulations, the Monitoring and ensuring the clinical portion of the study is inspection ready at all times. May also act as a single service project manager, or as a project manager for small studies.

Responsibilities:
• Recognize, exemplify and adhere to ICON's values which center 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. Actively identify 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. May act as the primary point of contact for smaller or single service projects.
• 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; lP 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 reports (MVR) and Follow up Letters (FUL) timelines, Action items (Al) 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 or take the role of a Global CTM.
• Responsible for co- coordinating, managing and mentoring the clinical project team to ensure high performance and productivity (e.g. Oays on Site tor CRnsl . optimal utilization, . continuous development . minimal turnover r all necessary project training is provided, documented and filed appropriately.
• Active involvement in clinical risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation and resolution
• Responsible for the development and maintenance of operational plans e.g. for clinical deliverables 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 ln archiving as necessary. This includes documented QC checks of in-house investigator site files.
• Ensure all closeout 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 memos.
• 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.
• Develop a succession plan for clinical study team members and, in the event of a change to the team, ensure an effective hand-over that is appropriately documented.
• Participate in the hiring interview process, if applicable.
• Maintain confidentiality of information, as appropriate.
• Participate in business development activities including bid defense meetings; may be required to provide input to the clinical strategy.
• May be required to undertake specific PM tasks, as agreed with Line Manager
• Participate in Company/Departmental Undertake other reasonably related duties as assigned

Qualifications:

•Previous experience as a CRA is desirable.

•Desirable experience with regional clinical studies

•5 to 8 years of experience as a CTM

• Prior monitoring experience is preferred

•Degree in Health

• Demonstrated ability to drive the clinical deliverables of a study

• Subject matter expertise in the designated therapeutic area

• Ability to travel up to 20%

•Advanced level of spoken and written English.

To be successful in the role, you will have:

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.