Proj Manager, Data Management
About the role
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- 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 15%) domestic and/or international.
- 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. Recruitment, performance evaluations and training .
- 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.
- Manage the forecast and revenue recognition process by continuous review of monthly files and incremental review of project analysis files to meet departmental objectives for profit and margins.
- Represent Data Management at internal and external audits and manage findings through resolution both operationally and within the Quality Management System
- Provide Project Management to Biostatistics and Medical Writing when Clinical Operations is not a function provided by ICON.
- 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.
- Develop supporting staff skills, encourage growth and provide regular performance feedback in one to one meetings and interim/yearly appraisals.
- Manage staff and set clear goals and objectives .
- Address performance issues promptly and devise a development plan to address areas for development.
- Effectively manage work priorities of self and direct reports, delegating responsibilities where appropriate .
- Monitors compliance to ensure studies are in line with internal quality Initiatives and that they are inspection ready.
- Monitor compliance to Track wise responses, PV timesheets, Veeva Vault; learn to ensure no backlogs built.
- 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 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.
- EU/APAC: In depth proven clinical research industry 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,
- Excellent interpersonal skills.
- Due to the nature of this positibn, 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.
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