Clinical Trial Manager II

As a Clinical Trial Manager II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Manages and prioritizes the clinical deliverables (e.g. site recruitment, site selection, subject/patient recruitment/enrollment, data monitoring, etc.) to ensure that deliverables meet quality and regulatory requirements, project timelines, budget, and sponsor expectations. Maintains thorough knowledge of contract details. Escalates out-of-scope task requests for review and approval prior to execution.
• Creates and administers clinical and site training plans. Ensures clinical team understands responsibilities and performance standards. Reviews metrics and other information sources to monitor team and individual performance. Provides timely feedback to address performance issues; shares performance information with functional manager as appropriate. Collaborates with a cross functional group of site monitors, site managers, biometrics team members to achieve successful delivery of data. Ensuring timely data entry, query resolution, on and off site data review, to ensure on time quality data deliverables.
• Maintains detailed knowledge of study resource requirements, burn rates and plans accordingly, ensures timelines, quality standards and budget expectations are met. Forecasts according to contractually agreed units/hours, tailoring to manage fluctuation of activities throughout project duration.
• Recognizes potential risks within the study protocol and operational aspects of the trial; serves as the primary liaison for clinical monitoring, site risks and issues; proactively establishes contingency and mitigation plans. Analyzes metrics and reports to keep abreast of performance. Leverages plans to address issues.
• Ensures that quality standards and applicable regulatory requirements are met. Collaborates with quality assurance department members to identify study sites requiring corrective and preventative action plans. Facilitates internal audits and local health authority inspections as needed.
• Oversees filing of study and site level essential documents by project team members to ensure that all initial or amended study information is submitted, approved and filed in accordance with the protocol, applicable guidelines and local regulations
• Communicates effectively with sponsor, project manager, functional team leads and other project team members. Selects appropriate communication platforms to convey information effectively and efficiently. Leads clinical study team meetings; presents at intra-/inter-departmental and external meetings.
• Creates, maintains and collaborates on applicable project documents, plans, templates and tools.

You are:

• Bachelor’s degree in a health, life sciences or other relevant field of study
• 8 years’ relevant experience
• Advanced project management skills
• Excellent leadership and influencing skills
• High proficiency with Microsoft Office and company collaboration applications

Why 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.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.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, colour, 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.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.