ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Location: (home-based OR office-based)
- United States
- Ireland
- South Africa
- United Kingdom
Overview of the role:
ICON’s Full-Service Data Management Clinical Data Services (CDS) Department is hiring a Manager, Data Management to oversee SDTM activities.
This person will be responsible for a team of SDTM leads and programmers and supporting the CDS Director of Data Management.
- Manage CDS team members and deliverables to ensure project objectives are met within budget, to agreed timeline, and to high level of quality.
- Manage CDS 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 KPIs 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.
- Provide input into SDTM deliverables and quality oversight.
- Develop supporting staff skills, encourage growth and provide regular performance feedback in one to one meetings and interim/yearly appraisals.
- Travel approximately 15% (Domestic/International)
To be successful, you will need:
- 5+ years of SDTM implementation experience
- 3+ years of experience as a 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
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.
In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
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