Senior Clinical Data Manager Job

SENIOR CLINICAL DATA MANAGER needed for a CONTRACT opportunity with Yoh's client located in Roswell, GA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Electronic Data Capture or EDC
- Data Management

WHAT YOU'LL BE DOING:

- Responsible for the day to day data management activities including developing Data Management Plans and Project CRFs from the protocol, annotating CRFs, conducting data cleaning, query management, and discrepancy management.
- Handle the data management components of the entire project and deliver accurate, timely, consistent, and quality clinical data.
- Responsible for the development and execution of the data management plan for the design, and implementation of clinical data collection, review, and clarification for a clinical study.
- Responsible for all data management related activities throughout course of clinical trial in preparation for database lock including data review and cleaning.
- Develop and maintain the following documents for the clinical database in Electronic Data Capture (EDC); database specifications, data validation (edit checks) specifications, report specifications and other functional specifications.
- Create User Acceptance Test (UAT) Plans, Test Scripts and execute testing.
- Detailed knowledge of study data requirements and relationships to facilitate data reconciliation, review and clarification activities.
- Develops and maintains the Data Management Plan (DMP), the Data Cleaning specifications, CRF completion guidelines and any other Data Management documentation.
- Responsible for Quality Control activities of clinical trial data prior to database lock.
- Ensure compliance with KC's SOPs, working procedures, and FDA, ICH, and GCP guidelines.
- Provide input for changes to Standard Operating Procedures and process improvements where appropriate.

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum of four to six (4 - 6) years of data management experience in medical device/pharmaceutical/biotechnology industry.
- Experience with Electronic Data Capture (EDC), Perceptive DataLabs preferred but not required.
- Experience with the development of reports using SAS, SQL and/or ad-hoc reporting tools.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Medical device clinical trial experience.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Kara Lloyd

Yoh, a DayJ2W: CLINICAL

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