JUMP TO CONTENT
Shortlist
search jobs Search
About the role ICON and you Application Process Day in the life Who we are

Clinical Data Lead

JR063976

About the role

This vacancy has now expired. Please click here to view live vacancies.
Clinical Data Lead
(This role can be based in any of the following locations;
Ireland, UK, Poland, Madrid, Paris or Strasbourg)
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
  • The point of contact for day to day activity on a study with key responsibilities for study set-up and close-out tasks as well as overseeing and coordinating tasks delegated to the study team members both locally and in other offices.
  • Coordinate with data management teams, studies and programs of studies and independently oversee the performance of data management activities on multiple studies.
  • Reporting to the Project Manager I Sr. Project Manager, Data Management.
Overview of the Role
  • Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Travel (approximately 10%) domestic I international.
  • Read, ensure understanding and adhere to all assigned ICON/Client SOPs and working procedures.
  • Ensure all work performed is of high quality , compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
  • Complete all assigned training (including the COL Development Program) and courses in the ICON Training Management system (iLearn); ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies.
  • Record all billable and non-billable time in the appropriate timesheet management system (e.g. Planview™).
  • Independently prepare all materials and take part in study kick off (internal and external) meeting.
  • Read, ensure understand ing and adhere to the study protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study.
  • Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the DMPM and Contract analyst.
  • Independently compile the change order log and distribute internally as per ICON's change order process.
  • Demonstrate an understanding of the revenue recognition and revenue forecasting process by independently performing revenue recognition and revenue forecasting process on a monthly basis.
  • Lead the development of specifications, implementation, and testing for the eCRF or paper CRF.
  • Lead the development of specifications, implementation, and testing for the edit checks and data review and oversight listings (DVS).
  • Lead development of the data management plan and study specific procedures.
  • Ensure effective implementation of standard metric and status reporting on the study.
  • Lead development of specifications for custom reporting on the study.
  • Independently perform project planning tasks and develop the project plan and timelines.
  • Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors.
  • Adhere to ICON/Client SOPs, the Data Management Plan, Working procedures and study specific procedures in the implementation of tasks on the study.
  • Adhere to the project plan and timelines in the implementation of study tasks during set-up, maintenance and close-out of the study.
  • Key point of contact for the sponsor and the study team on day to day study data issues, eCRF design, edit checks, and other implemented components.
  • Independently attend and provide an update for data management services at cross- functional study team meeting both internally and with the sponsor.
  • Maintain and track meeting minutes, issues and decisions logs, and escalations.
  • Independently negotiate the time lines and make study level decisions.
  • Provide regular study status updates to the DMPM.
  • Support the DMPM in the delivery of study specific training to all team members, ensuring that the training is documented and the documentation filed in the Data Management Study files.
  • Assess the training needs of study team members on an ongoing basis.
  • Provide refresher training to team members as required.
  • Provide feedback to the DMPM on issues with study team member performance .
  • Deliver training to cross-functional study team members both internal and external (e.g. training in the study specific electronic CRF for monitors or Site staff at the investigatory meeting).
  • Represent Data Management at internal/external audits and manage findings through resolution both operationally and within the Quality Management System
  • Participate in Business Development presentations to sponsor as required.
Role Requirements
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily . The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • US/LATAM/CAN: A minimum of 5 years clinical data management experience including 3 years' experience as a data management lead or point of contact for day to day activity on studies with key responsibilities for study set-up and close-out tasks as well as overseeing and coordinating tasks delegated to the study team members.
  • EU/APAC: Prior relevant clinical research industry experience.
  • Experience of at least one of ICON preferred CDMS (e.g. Rave, Inform, Oracle Clinical, OCRDC, UX EDC)
  • Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project).
  • Excellent communication and interpersonal skills, both verbal and written skills.
  • Strong client relationship management skills and the aptitude to develop this further.
  • Excellent organizational and planning skills as well as a demonstrated aptitude for project management, and the ability to lead more than one project and prioritize accordingly.
List #1

Day in the life

Liquid drug vials in palm of hand
Understanding INDs and NDAs in Clinical Research

Teaser label

Industry

Content type

Blogs

Publish date

04/22/2025

Summary

What is an IND or NDA? A Guide for Aspiring Clinical Research Professionals If you’re considering a career in clinical research or the broader pharmaceutical and biotech industry, you’ve likely c

Teaser label

Discover the difference between IND & NDA applications, and the steps from drug development to regulatory approval.

Read more
Informed consent form
What is an Informed Consent Form (ICF)?

Teaser label

Industry

Content type

Blogs

Publish date

04/22/2025

Summary

When it comes to clinical trials, one of the most important documents you’ll hear about is the Informed Consent Form (ICF). Whether you're starting out in clinical research or exploring job opportunit

Teaser label

Learn what an Informed Consent Form (ICF) is, why it’s essential in clinical research, and how it protects participants.

Read more
Medic in full gown with a clipboard
Clinical Research Associate (CRA) vs Clinical Research Coordinator (CRC)

Teaser label

Industry

Content type

Blogs

Publish date

04/17/2025

Summary

CRA vs CRC Embarking on a career in clinical research is an exciting journey for STEM graduates, offering opportunities to contribute directly to the development of new therapies and to safeguard

Teaser label

Discover the key differences between Clinical Research Associates (CRA) and Clinical Research Coordinators (CRC).

Read more
View all

Similar jobs at ICON

CRA II - West Coast

Salary

Location

United States

Department

Clinical Monitoring

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The primary responsibilities of this position include assessin

Reference

2025-118551

Expiry date

01/01/0001

Jamie Pruitt

Author

Jamie Pruitt
Jamie Pruitt

Author

Jamie Pruitt
Read more Shortlist Save this role
Read more Shortlist Save this role
Senior Drug Development Director - Home-Based (East Coast)

Salary

Location

United States

Department

Project Management Roles

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Project Management

Job Type

Permanent

Description

The Drug Development Project Manager (Senior Drug Development Director) oversees the high-level plans and progress of these teams, managing projects from pre-clinical stages through to commercializati

Reference

2025-119094

Expiry date

01/01/0001

Kala Murphy

Author

Kala Murphy
Kala Murphy

Author

Kala Murphy
Read more Shortlist Save this role
Read more Shortlist Save this role
Senior Drug Development Director - Home-Based (East Coast)

Salary

Location

United States

Department

Project Management Roles

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Project Management

Job Type

Permanent

Description

The Drug Development Project Manager (Senior Drug Development Director) oversees the high-level plans and progress of these teams, managing projects from pre-clinical stages through to commercializati

Reference

2025-119093

Expiry date

01/01/0001

Kala Murphy

Author

Kala Murphy
Kala Murphy

Author

Kala Murphy
Read more Shortlist Save this role
Read more Shortlist Save this role
Senior Clinical Scientist

Salary

Location

United States

Department

Scientist

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Scientist

Job Type

Permanent

Description

As a Senior Clinical Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-119083

Expiry date

01/01/0001

Melissa Benner

Author

Melissa Benner
Melissa Benner

Author

Melissa Benner
Read more Shortlist Save this role
Read more Shortlist Save this role
Medical Technologist-all levels- I, II and Senior

Salary

Location

US, Farmingdale, NY

Department

Full Service - Development & Commercialisation Solutions

Location

New York

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Laboratory

Job Type

Permanent

Description

Medical Technologist multiple levels I, II, Senior - Farmingdale, NYICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environme

Reference

JR130208

Expiry date

01/01/0001

Frank Lampart

Author

Frank Lampart
Frank Lampart

Author

Frank Lampart
Read more Shortlist Save this role
Read more Shortlist Save this role
CRA II

Salary

Location

Portugal, Lisbon

Department

Clinical Monitoring

Real World Solutions

Location

Lisbon

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team in Portugal for ICON Biotech. As a Clinical Research Associate II Specialist at ICON, you will play a piv

Reference

JR129661

Expiry date

01/01/0001

Sophie Bingham

Author

Sophie Bingham
Sophie Bingham

Author

Sophie Bingham
Read more Shortlist Save this role
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above