Proj Manager, Data Management
About the role
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- Recognize exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
- 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 15%) domestic and/or international.
- Manage a 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.
- 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 KPls 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.
- Lead, coordinate or participate in the design, development and implementation of departmental and company Initiatives.
- Provide input into CRF design, protocol review, edit check specifications, data entry conventions, monitoring guidelines, and any other study related documents, as required.
- *Direct, lead, or perform the development, validation, and User Acceptance Testing of the clinical data management system database and associated edit checks.
- *Direct, lead, or perform all Data Management data processing, data reconciliation, query generation and resolution, cleaning, medical coding, quality review tasks, database close/lock, and relevant archiving of study materials.
- *Resolve issues for assigned projects related to quality, project delivery, compliance, and/or client relationships and satisfaction.
- 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.
- Effectively manage work priorities, delegating responsibilities where appropriate Monitors compliance to ensure studies are in line with internal quality Initiatives and that they are inspection ready.
- Acts as mentor to all junior staff levels.
- 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/LATAM/CAN: A minimum of 8 years clinical data management experience.
- 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.
- Knowledge of relevant CDISC standards, such as CDAS H and SDTM, is preferred.
- Prior experience with successfully leading clinical data management project team is strongly preferred.
- Ability to liaise successfully with project teams and sponsors, including excellent written and verbal communication skills.
- Excellent interpersonal skills.
- Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver's license.
- Bachelor degree or local equivalent in a scientific discipline and/or appropriate experience.
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