Senior Clinical Data Manager

Company Name:
Synergy America, Inc.
Senior Clinical Data Manager We are looking for a Senior Clinical Data Manager for a 1 year contract in Roswell, GA. Also candidates can work remotely from Philadelphia, PA only. The Senior Clinical Data Manager has extensive industry experience (including EDC) and is 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. The Senior Clinical Data Manager will handle the data management components of the entire project and deliver accurate, timely, consistent, and quality clinical data. Responsibilities: - 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.- Responsible for database archiving and study close-out processes and procedures.- Maintain consistent approaches and standards within and across projects.- Meets reasonable timelines for department deliverables and identifies any data management issues.- Works closely with all clinical data management team members working on the studies, coordinating activities and resources as appropriate.- Ensure compliance with Client's SOPs, working procedures, and FDA, ICH, and GCP guidelines.- Provide input for changes to Standard Operating Procedures and process improvements where appropriate Skills: - Prefer 6 years of experience. medical device clinical trial experience preferred but not required. Must have EDC (Electronic Data Capture) experience. It doesn't matter what platform they use.- Minimum of 4-6 years 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- Ability to juggle multiple tasks and priorities- Analytical and problem-solving skills, with good attention to detail- Excellent communication skills (oral and written) and interpersonal skills- Ability to handle a fast-paced environment with a sense of urgency and commitment to meet deadlines on time- Education Bachelor's degree in related science/technical discipline required Interested candidates please send your resume MYK62683JR

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