Lead and Senior Clinical Data Managers- Required
I am currently recruiting for a global CRO operating in over 80 countries. They are one for the industry leaders striving to be the best at what they do. To achieve this goal it all comes down to employing the best minds and workers out there. If you also strive for the best, this company would be the perfect match for the next step in your career. The role is permanent and candidates can be based In UK or In Europe and will be able to work from home.
This is an exciting opportunity to work within busy environment for a leading global provider in the Life science sector.
- 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.
- 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 and courses in the Training Management system. 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 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.
- 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 Auditors.
- 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 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 .
- 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.
- 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.
To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.
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