Clinical Data Lead

1 week ago

Remote, United Kingdom ICON Full time
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 Outsourced Data Management Operations Lead manages the end to end clinical data flow (data acquisition from Case Report Form (CRF) development to Clinical Study Reporting (CSR) of Clinical Data) and ensures timely project execution, quality data deliverables, and prioritization of all DM milestone delivery. Recognized as the DM operational specialist in clinical data flow and study execution by all functions within their assigned SMTs.
  • Is managed and directed by ICON Line Managers and supports ICON initiated internal process improvement initiatives. The Outsourced Data Management Operations Lead will not be assigned to support sponsor internal process improvement initiatives and will not attend sponsor company internal events and/or town hall meetings.
  • By acting as the primary Data Management (DM) representative to the study management team, the outsourced DM Operations Lead partners with Sponsor Data Management Portfolio Lead and other key study/program team members to implement project plans for assigned studies, ensuring the functional activities are completed by external data vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with external data vendors to support the flawless execution of a clinical trial.
  • Uses phase, TA and operational knowledge to establish and implement study level operational plans and oversees vendors to ensure on time project delivery on all assigned projects.
  • Develops study level quality/oversight plans and ensures adherence and consistent execution across the data flow. Collaborates with sponsor DM Portfolio Leads to ensure alignment of study operational plans with program goals. Contributes to and/or accountable to update and manage study dashboards, timelines, resource prioritization, and data deliverables.
  • Degree educated in a relevant field.
  • 5 + years relevant Clinical Data Management experience.
  • Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project)
  • Knowledge of clinical trial database technologies and processes.
  • Is accountable and proactive in quality and risk management.
  • Ability to liaise successfully with sponsors.
  • Excellent written and oral communication skills.
  • Excellent accuracy and attentiveness to detail.
  • 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.
  • Previous experience and proven competence in managing study delivery through full DM lifecycle
- (planning, start-up, conduct, lock and closeout)

  • Deep understanding of drug development and biopharmaceutical industry required
  • Robust experience with Medidata Rave and use of Data Review tools such as J-Review or Business
  • Strong project management skills, and ability to effectively lead and collaborate with various business
- functions project management certified desirable

  • High attention to detail including proven ability to manage multiple, competing priorities
  • Experience working on outsourced clinical trials
  • Experience developing and implementing DM process and data standards
  • Demonstrated ability to establish effective business process and relationships with external stakeholders, including implementing process change
  • Demonstrated ability to influence without authority

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 rece

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