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The Manager, IDEA is primarily responsible for data monitoring committee and endpoint adjudication projects and project team oversight. This position oversees multiple projects and is responsible for establishing strong positive working relationships and processes with clients in order to secure future business opportunities. This position oversees project staff resources and study personnel training. This position serves as a direct line manager for Project Assistants, Clinical Reviewers, and Project Managers.
Job Responsibility:
Recognize, exemplify and adhere to ICON's values which center 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 30%) domestic and/or international
Provides line management to department staff consisting of Project Managers, Clinical Reviewers, and Project Assistants
Keeps Director and/or Senior Director apprised of any potential/actual study or staffing issues and provides solutions for the same
Coordinates and implements department training and identifies training needs
Provides data monitoring committee and event adjudication training to other departments as requested
Ensures staff training records are in compliance
Serves as a mentor and role model for all team members
Provides support to Project Manager in the development of project processes, workflows, and training materials as needed
Provides support to Project Manager regarding their collaboration with internal and external study team members as needed
Establishes and maintains strong positive working relationship with clients to improve process efficiencies across protocols, and increase future business opportunities
Provides oversight, leadership, and structure for customer service interface from proposal generation, bid defense, service delivery, to trial closeout
Provide project process and financial oversight and support to project team members
Evaluates and secures project departmental staff resources
Serves as subject matter expert to support team members in identifying and overcoming project related challenges
Develops and implements department initiatives to improve client satisfaction, process efficiency, cost savings, quality improvement, and staff satisfaction
Maintains quality metrics and attends project quality review meetings as required
Attends bid defense meetings and provides input on new business proposals
Ensures audit readiness and participates in internal, client, vendor, and regulatory audits
Participates in the development and revision of departmental standard operating procedures and work instructions
Other activities as identified and requested by Director and/or Senior Director
Requirements:
Bachelor's Degree, or local equivalent, in medicine or science
Licensed professional nurse or similar medical/scientific certification
Prior relevant clinical trial experience
Basic knowledge of applicable global, regional, local clinical research regulatory requirements
ie Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, standard operating procedures (SOPs), or the ability and willingness to gain this knowledge
Previous clinical trial and managerial experience required
Previous Project Management experience required
Demonstration of professional demeanor, judgment and discernment in interactions with Clients, colleagues, and other ICON staff
Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or Sponsors
Excellent computer skills (Microsoft Word, Excel, PowerPoint, Outlook)
Experience working with electronic data capture and transfer methods
Knowledge of medical terminology
Excellent communication, documentation, and presentation skills
Excellent organizational, time management and problem-solving skills
Strong sense of responsibility and dedication
Attentiveness to detail and accuracy
ability to maintain quality standards
Ability to follow instructions/guidelines, utilize initiative and work independently
Proven ability to multi-task, manage competing priorities and timelines
Due to the nature of this position it may be required for the employee to travel
Therefore, dependent on the employees location, the employee may be required to possess a valid Drivers license
What we offer:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others