Ref #: 33068

Employment type: Permanent - Full-Time

Location: Poland (Home-based; any location)

Posted: 10-Nov-2021


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.

Job Details:
The role of the Study Data Manager 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. The SDM is also 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.

Responsibilities include:
-Ensuring clinical projects are executed according to set timelines with quality and consistency
-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

Key Activities:
-Responsible for the project deliverables such as:
-Planification of all data management activities, considering the overall study timelines
-Protocol review and defining data collection strategy eCRF design and review
-Defining data cleaning and validation strategy integrating risk-based approach
-Data Management Plan and Centralized Monitoring Plan
-Review of all other DM documents within a project area to ensure a consistent approach
-Coordinating vendor external data activities: load, integration activities and reconciliation activities, including External Lab data, eCOA, IRT integration etc.
-Database locks and unlocks
-Actively monitor progress of clinical projects within assigned product area to ensure delivery to set timelines and quality standards
-Represent DM at study team meetings
-Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
-Co-ordination of aSDM within the project
-Develop QC strategy and ensure that quality control checks are occurring such that quality databases are delivered
-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
-Promote and be an advocate of DM internally and externally

-At least 5 years work experience in data management in the Pharmaceutical or Biotech area
-Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.) is an asset

If you are seeking an international company who is committed to development and training and the opportunity for career progression, please get in contact.

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 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.

#datamanagement #datamanageropportunity