Ref #: 32602

Employment type: Permanent - Full-Time

Location: Poland

Posted: 28-Sep-2021

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre 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.

The Role:

• In this role you will provide complete oversight of a given project or projects and is responsible for leading and coordinating the end-to-end quality deliverables of data management activities for clinical trial including study set-up, conduct and closeout.
• You will also be responsible for execution of Data Management (DM) activities per set timelines with quality and consistency and will provide comprehensive data management expertise and support to study team members cross functionally.
• Leading DM activities for a given project or multiple projects
• Ensuring that DM procedures and processes are adhered to by FSP staff through oversight of quality, cycle times, metrics and use of the Issue CAPA process
• Co-ordination of associate SDM (aSDM) within assigned projects
• Oversight of FSP vendors with respect to quality, Issue & CAPA tracker & KPI metrics
• Manage vendor deliverables and relationship at the project level
• Review of all study level non DM documents for awareness and project level consistency
• Lead electronic submission activities
• Assist with response to questions and findings from Clinical Quality including participating in project level audit
• Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM
• Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education


To be successful in the role, you will have:

• 4- 6+ years work experience in data management in the Pharmaceutical or Biotech area
• 3+ years project management and planning experience
• Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.)


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.