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Senior Clinical Data Specialist
3 weeks ago
Clinical Data Management Professional
">- Job Description:
We are seeking an experienced Clinical Data Management professional to join our team. In this role, you will be responsible for overseeing clinical data management activities, ensuring data quality and integrity, and collaborating with cross-functional teams.
Main Responsibilities:
- Document Tracking and Control: Responsible for project-specific and departmental document tracking and control activities.
- Clinical Document Review: Reviews CRF (as per protocol) and project-specific documents.
- Data Management: Initiates project-specific DMTMF (Data Management Trial Master File) and e-filing, and reviews it on an ongoing basis.
- Document Preparation: Prepares project-specific documents.
- Client and Team Coordination: Handles requests/issues by the client and team, in coordination with PM.
- Database Design: Coordinates with CDA in User Acceptance Testing (UAT) leading to robust database design.
- Procedure Verification: Performs procedure verification as a part of database validation.
- Data Clarification Forms: Creates, reviews, processes, and tracks Data Clarification Forms and updates clinical databases for ensuring data validity as per the protocol.
- Manual Data Listings: Conducts manual data listings as needed.
- Training and Support: Assists in maintenance of the documents for Pre-production and Pre-lock audits, conducts project and process specific training for subordinates, and acts as a back-up for Data Manager.
- SOP Compliance: Ensures SOP compliance in project deliverables and ensures compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.
Requirements:
- Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or related field.
- Experience: Minimum 3 years of experience in clinical data management.
Benefits:
This is a challenging role that requires strong analytical skills and attention to detail. If you have a background in clinical data management and are looking for a new opportunity, please apply.
About Us:
We are a company that values professionalism and excellence in all aspects of our work.
