CDL
About the role
This vacancy has now expired. Please see similar roles below...
- Recognize, exemplify and adhere to ICON's values which centers on 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 tasks 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.
- Bachelor degree or local equivalent in a scientific and/or appropriate experience.
- Minimal travel may be required (less than 5%).
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
Inside ICONContent type
BlogsPublish date
04/18/2024
Summary
Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis
Teaser label
IndustryContent type
BlogsPublish date
04/18/2024
Summary
Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials
Teaser label
IndustryContent type
BlogsPublish date
04/12/2024
Summary
Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ
Who we are
Similar jobs at ICON
Salary
Location
Boston
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Boston
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Quality Assurance
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
2023-107609
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa BennerSalary
Location
Turkey
Department
Clinical Monitoring
Location
Turkey
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
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, biotech
Reference
2023-104179
Expiry date
01/01/0001
Salary
Location
Singapore
Department
Clinical Monitoring
Location
Singapore
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Senior Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with one
Reference
2023-103968
Expiry date
01/01/0001
Author
Sitti LimAuthor
Sitti LimSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. A CRA is a professional who cont
Reference
2023-103904
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Argentina
Department
Clinical Trial Management
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Trial Manager you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.
Reference
2023-103323
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Belgium, United Kingdom, Denmark, France, Spain, Germany, Netherlands, Switzerland
Department
Medical Affiars & Medical Writing Roles
Location
Belgium
Denmark
France
Germany
Netherlands
Spain
Switzerland
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As principal medical writer, you will be
Reference
2023-103952
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia Roth