Manager, IDEA in Reading

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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.

Responsibilities

• 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.

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.

• 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.