Clinical Data Manager

Proclinical is currently recruiting for a Clinical Data Manager with a pharmaceutical company located in Durham, NC.

Job Responsibilities:

• 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
• Adhere to 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

Skills and Requirements:

• 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.
• Experience of at least one of 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.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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