Sr. Clinical Trial manager
About the role
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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
Application process
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Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
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