ICON Government and Public Health Solutions specializing in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts to global health crises.
ESSENTIAL FUNCTIONS:
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
- 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.
- Oversee the building of the Statistical and Data Coordinating Center (SDCC).
- 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.
Candidates for positions under ICON Government and Public Health Solutions contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT:
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.
Experience
Required
- Experience building and managing Statistical and Data Coordinating Center (SDCC) solution, US Government experience preferred.
- A minimum of 10 years clinical data management experience. A minimum of 5 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.
- 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.
- Ability to identify issues, track progress, and follow through on actions to meet customer satisfaction.
- Strong written and oral communication skills.
- Proven leadership skills and capability to work within a team environment
- Capability to manage competing priorities in a changeable environment
- Must be able to work independently following a brief period of specific technical training.
Education
Preferred
- Bachelors or better
Behaviors
Required
- Leader: Inspires teammates to follow them
- Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well
Preferred
- Enthusiastic: Shows intense and eager enjoyment and interest
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractorâs legal duty to furnish information. 41 CFR 60-1.35(c)
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