CDL
About the role
This vacancy has now expired. Please see similar roles below...
The lead data management 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, reporting to the Data Management Project Manager.
Job Responsibilities
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/international
Read, ensure understanding and adhere to all assigned ICON 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 Study Lead 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. PlanviewTM)
Take part in study kick off (internal and external) meeting along with the DMPM
Read, ensure understanding 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
Assist in compiling the change order log for review by the DMPM
Develop an understanding of the revenue recognition and revenue forecasting process
Assist the DMPM with 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
Perform project planning tasks and support the DMPM in the development of 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 SOPs, the Data Management Plan 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
Organize and lead regular data management team meetings, both internal and with the sponsor and the DMPM
Attend and provide an update for data management services at cross-functional study team meeting both internally and with the sponsor and the DMPM
Maintain and track meeting minutes, issues and decisions logs, and escalations
Support the DMPM in negotiation of time lines and decision making on the study
Provide regular study status update 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
Support the DMPM in the delivery of 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)
Job 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 3 years clinical data management experience.
EU/APAC: Prior relevant clinical research industry experience.
Experience of at least one of ICON preferred CDMS (Rave, Inform, Oracle Clincal, OCRDC)
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
Education:
Bachelor’s degree or local equivalent in a scientific discipline and/or appropriate experience
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Our PeopleContent type
BlogsPublish date
03/27/2024
Summary
Exploring Lucy's Path: From Science to Communications Lucy's career journey is a testament to the power of adaptability and seizing opportunities as they arise. "I've been in Clinical Research si
Teaser label
Career ProgressionContent type
BlogsPublish date
03/27/2024
Summary
Interviews can be nerve-wracking experiences, but with the right preparation, you can enter the room with confidence and increase your chances of success. Preparing for an interview is crucial a
Teaser label
Career ProgressionContent type
BlogsPublish date
03/27/2024
Summary
Clinical research plays a crucial role in advancing medical knowledge and improving patient care. At the heart of every successful clinical research study is a Clinical Research Coordinator (CRC
Who we are
Similar jobs
Salary
Location
United States
Department
Clinical Operations Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109246
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon PupekSalary
Location
Netherlands
Department
Clinical Monitoring
Location
Netherlands
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a single sponsor dedicated Clinical Research Associate at ICON, you will be partnering with a global pharmaceutical company with focus on oncology trials, where you will be responsible for the Neth
Reference
2024-109326
Expiry date
01/01/0001
Author
Vanessa VerdicktAuthor
Vanessa VerdicktSalary
Location
India, Bangalore
Department
Full Service - Laboratory
Location
Bangalore
Bengaluru
Remote Working
Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Sales
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR117435
Expiry date
01/01/0001
Author
Moushami RoyAuthor
Moushami RoySalary
Location
United States
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Logistics & Supplies
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109389
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon PupekSalary
Location
London
Department
Clinical Monitoring
Location
London
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
UK-Based experienced In Vitro Diagnostics CRA required to augment existing team of IVD CRAs. Target candidate profiles are >BSc educated UK-based experienced CRAs with a Lab-based background. You will
Reference
2024-109281
Expiry date
01/01/0001
Salary
Location
Poland, Warsaw
Location
Warsaw
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR116578
Expiry date
01/01/0001
Author
Andreia SilvaAuthor
Andreia Silva