Senior Clinical Data Lead

Senior Clinical Data Lead - Warsaw

ICON Plc is a leading Clinical Research Organisation headquartered Dublin, Ireland. Founded in Dublin in 1990 with a team of 5, ICON Plc now employs over 13,000 people in 38 countries.

The Role:

Due to exciting new business wins, we are currently recruiting for a Senior Clinical Data Lead to join the team our offices in Warsaw, Poland. The successful applicant will act as the point of contact day to day activity on clinical studies with key responsibilities for study set up and close out tasks as well as overseeing and coordinating tasks delegated to the study team member both locally and in other offices.

The successful applicant will join the Data Management team and will report to a Project Manager based in Dublin.

Responsibilities will include:

• Adhere to all assigned ICON/ Client SOPs and working procedures.
• Ensure that all work is preformed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
• Prepare all materials and take part in study kick-off meetings.
• Understanding and adhering to the study protocol, contract and scope of work for all tasks during set-up, maintenance and close out of study.
• Preforming project planning tasks, developing time lines etc.
• Reviewing activity on an on-going basis to identify out of scope tasks and bring to the attention of the DMPM and contract analyst.
•  Compiling and distributing change order logs.
• Forecasting and reporting on revenue.
• Leading the development of specifications, implementation and testing for edit checks and data review and oversight listings
• Leading the development of the data management plan and study specific procedures.
• Leading the development of specifications for custom reporting on the study.
• Ensuring all data management study files are audit ready.
• Act as a key point of contact for the study sponsor and the study team.
• Arranging and team meetings – internally and with the sponsor. Logging all meeting minutes.
• Assisting with team training where required.
• Representing Data Management team at internal and external audit meetings.
• Participate in business development presentation as required.
• Supervisor and mentoring responsibilities as required.

Experience Required:

• Degree in Science.
• 5 years Data management experience, with 2 years in a lead DM role.
• Experience working with some of the following systems: Rave, Inform, OCRDC, UX EDC etc.
• Strong team player with great communication and influencing skills.
• Excellent relationship building skills.
• Highly organised with a drive to get things done.

Benefits of Working in ICON

ICON enjoys a strong reputation for quality and is focused on staff development.  We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career.  We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.  

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.  

*Travel (approximately 10%) domestic and/or international