Clinical Trial Manager

SUMMARY

To act as the Functional Lead for Clinical Operations within Project Operations of ICON’s Late Phase and Outcomes Research Division (ILPOR) with responsibility for delivery of all Clinical Operation aspects of clinical studies ensuring consistency with ICON SOPs, study contracts and budgets

 JOB FUNCTIONS/RESPONSIBILITIES

Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.

As a Manager, 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.

Travel (approximately 25%) domestic and/or international

Primary Point of contact for Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients

Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects

Contribute to the development and maintenance of cross functional project management plans

Responsible for risk mitigation associated with action plan and issue resolution

Responsible for managing the Clinical Operations project team including ensuring all necessary project training is provided to assigned staff

Provide direction and support to the Clinical Operations study team

Manage Clinical Operations aspects of projects in accordance with the contract including:

Proactively communicate any changes in clinical operations scope to the Project Manager

Collaborate with Contracts Management as appropriate to ensure timely completion of change orders

Track Clinical Operations project deliverables using appropriate tools

Effectively monitor and report on progress of the clinical operations aspects of projects to all stakeholders

Implement QC activities as necessary and monitor required quality metrics

Develop a succession plan for clinical operations study team members and, in the event of a change to the team, ensure an effective hand-over

Maintain confidentiality of management information, as appropriate

Participate in business development activities including bid defence and proposal as appropriate

Other duties as assigned

 SUPERVISION

Manage additional project resources as required including Project Assistants

Set clear goals and drive a performance culture through their teams and direct reports

 EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

US/CAN/LATAM:   A minimum of five (5) years of clinical study experience including experience as a LEAD CRA or LEAD PA with some experience in clinical monitoring preferred.

EU/APAC:  In depth proven experience including experience as a LEAD CRA or LEAD PA with some experience in clinical monitoring preferred.

Thorough knowledge of relevant regulations for the conduct of clinical studies

Some knowledge of project management processes and tools

Key Competencies

Critical thinking and problem solving skills

Planning and organizing

Risk assessment and mitigation skills

Excellent Communication skills

Influencing and leading

Decision making

Strong people management and effective communication skills

Good commercial awareness and customer focus

Negotiation skills

Conflict management skills

Fluent in written and spoken English.  Additional language skills desirable

Computer literate

Due to the nature of this position it may be required to travel.  Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s License

 EDUCATION REQUIREMENTS

University/Bachelor’s Degree, or local equivalent, in medicine, science or equivalent degree/experience