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Senior CDC

US-Pennsylvania-North Wales
Permanent
Reference: 053151
This vacancy has now expired.
Description
Senior Clinical Data Coordinator
 
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.  To fulfill his I her job responsibilities in accordance with Good Clinical Practices (GCPs}, IC   N Standard Operating Procedures (SOPs}, Working Procedures (WPs},Study Specific Procedures (SSPs), International Committee on Harmonization (ICH) Guidelines , and all applicable law   and regulations.
 
Overview of the Role
  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to recognize the importance of and create culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Travel (approximately 0%) domestic and I or 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 trainings (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 s stem (e.g. Planview™).
  • Review CRF I eCRF data for completeness, accuracy, and consistency via computerize   edits and manual data checks.
  • Perform external data reconciliation.
  • Perform Serious Adverse Event reconciliation.
  • Generate and close/resolve (as appropriate) data queries.
  • Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System.
  • Create and maintain study files and other appropriate study documentation.
  • Perform User Acceptance Testing and collaboratively work with CDMS personnel.
  • Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures.
  • Train and guide less experienced CDCs in data management requirements and activities.
  • Perform other project activities as required in order to ensure that study timelines a e met (for example, filing and archiving of study documentation , dispatching of queries to investigation or sites for resolution, etc.).
  • As required, communicate effectively with the Project team, Study Lead, Project Lead and Project Manager.
 
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, a d/or ability required. Reasonable accommodations may be made to enable individuals with disability to perform the essential functions.
  • US/LATAM/CAN: A minimum of 2 year relevant clinical research industry experience.
  • EU/APAC: Prior relevant clinical research industry experience.
  • Excellent written and oral communication skills.
  • Excellent accuracy and attentiveness to detail.
  • Capability to work within a team environment.
  • Excellent interpersonal skills.
  • Knowledge of database technologies and processes.
  • Knowledge of regulatory guidelines in relation to data quality and clinical trials conduct.
 
Benefits of Working in ICON
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
 
What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 
 
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
 
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