Ref #: 26466

Employment type: Permanent - Full-Time

Location: US - Nationwide

Description

Position Summary:
• Recognize exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• Manage the Data Management team, study and or program of studies to ensure project objectives are met within budget, to agreed timeline and to high level of quality.
• Manage clinical data management staff as appropriate, including but not limited to resource planning.
• Develop and foster sponsor relationships through effective project management and communication.
• Represent or offer significant contributions to the representation of data management on specific sponsor partnerships and/or alliances provide regular status reports and KP ls to senior management and represent Data Management at oversight meetings.
• Represent Data Management at internal and external audits and manage findings through resolution both operationally and within the Quality Management System
• Contribute to the development, implementation and maintenance of guidelines and procedures (SOPs, Training manuals, etc.) to facilitate the efficient performance of data management activities.
• Actively participate in departmental and company initiatives.
• Actively participate in the development of departmental specific training courses and conduct instructor led training courses for data management staff.
• Provide input into CRF design, protocol review, edit check specifications, data entry conventions, monitoring guidelines, and any other study related documents, as required.
• Actively participate in Business Development presentations to sponsors as required.
• Assist Business Development colleagues with the preparation of Data Management bids as required.
• Provide other general duties as required to support the company.

Experience:
• A minimum of 6 years clinical data management experience. A minimum of 3 years' experience as a data management lead or point of contact for day to day activity on studies with key responsibilities for study set-up and close-out tasks as well as overseeing and coordinating tasks delegated to the study team members.
• Appropriate experience and understanding of at least one clinical data management system (e.g.) RAVE, INFORM, OCRDC)
• Knowledge of FDA regulations and all relevant local or regional regulations respecting data quality and clinical trials conduct.
• Strong written and oral communication skills.
• Proven leadership skills.
• Capability to work within a team environment
• Capability to manage competing priorities in a changeable environment.
• Capability to handle stressful situations and deadlines
• Excellent interpersonal skills.
• Bachelor degree or local equivalent in a scientific and/or appropriate experience.