Lead Data Manager

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 Lead Data Manager (LDM) is capable of leading Data Management aspects of a clinical study with some support and oversight and will ensure that study level deliverables are completed on time, with quality, and in accordance with corporate and regulatory requirements. The LDM has a working knowledge of FDA regulations and general industry standards.

• Lead all data management aspects of a clinical study with minimal oversight, including study start-up activities, and guide the study team through change orders and protocol amendments
• With minimal oversight, develop DM documents including, but not limited to, Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to initiate documents, but exercise critical thinking and discretion to tailor documents to study needs
• With minimal oversight, lead data cleaning activities such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation and non-CRF data reconciliation. Gather cross-functional input to create custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths
• Demonstrate collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.)
• Run SAS programs, review SAS logs, and generate output. Research and resolve even complex data discrepancies. May program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level
• With minimal oversight, manage data deliverables processes, including database locks
• DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct
• Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product
• Demonstrate "everyday leader" qualities

• Years of experience: 3-7 years; dependent on level of related skills and education

• Effective organizational and communication skills
• Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession
• Detail oriented; performs quality and accurate work
• Thorough knowledge of FDA regulations and ICH GCP guidelines and the DM Lifecycle; subject matter expertise may substitute for broader DM lifecycle knowledge

• Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively

• Preferred:
  • Previous experience with RTSM/IWRS and ePRO systems
  • Database development experience
  • SAS programming experience
  • Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
  • Previous relevant EDC experience
  • Previous vendor/CRO management
  • Oncology experience and/or working knowledge
• BA/BS in relevant field. Years of experience may substitute for education.

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.