Clinical Data Lead
About the role
This vacancy has now expired. Please click here to view live vacancies.
- 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.
- 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.
- 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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
.png)
Teaser label
IndustryContent type
BlogsPublish 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
.png)
Teaser label
IndustryContent type
BlogsPublish 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
.png)
Teaser label
IndustryContent type
BlogsPublish 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
Similar jobs at ICON
Salary
Location
US, Lenexa KCI (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Lenexa
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Nurse
Job Type
Permanent
Description
We are currently seeking a Clinical Research Nurse I to join our diverse and dynamic night-shift (6pm - 7am) team. As a Clinical Research Nurse I at ICON, you will play a pivotal role in supporting th
Reference
JR125760
Expiry date
01/01/0001
Author
Muna NelkeAuthor
Muna NelkeSalary
Location
Poland
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Poland
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Corporate Support
Job Type
Permanent
Description
As a Senior CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-119048
Expiry date
01/01/0001
Salary
Location
Poland
Department
Clinical Operations Roles
Location
Poland
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
As a Senior Clinical Trial Transparency Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will oversee and
Reference
2025-118310
Expiry date
01/01/0001
Author
Swathy AnandanAuthor
Swathy AnandanSalary
Location
Poland
Department
Clinical Monitoring
Location
Poland
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Senior CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-118700
Expiry date
01/01/0001
Salary
Location
Spain, Madrid (Accellacare)
Location
Madrid
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Patient Recruitment
Job Type
Permanent
Description
Patient Recruitment Assistant At Accellacare - an ICON Company, it’s our people that set us apart.As a global provider of drug development solutions, our work is serious business but that doesn’t mean
Reference
JR128517
Expiry date
01/01/0001
Author
Clodagh FinneganAuthor
Clodagh FinneganSalary
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 Site Care Partner you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-119027
Expiry date
01/01/0001
Author
Brendan HoeyAuthor
Brendan Hoey