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6.0 - 10.0 years
0 Lacs
kolkata, west bengal
On-site
As a Clinical Data Management professional with at least 6 years of experience, you should have exposure to Study Start up, Conduct, and Study Closeout phases. It is essential to have hands-on experience with Rave (Medidata) or Veeva EDC. Your key responsibilities will include: - Setting up DMP (Data Management Plan), creating Edit checks, Data Transfer specifications, and having knowledge of UAT. - Conducting Data Cleaning, managing Query Handling, Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, and Dataset review. - Freezing/Locking studies effectively during Study Lock phase. - Engaging in client-facing roles and providing me...
Posted 2 days ago
0.0 - 3.0 years
0 Lacs
karnataka
On-site
As a Clinical Research Coordinator at Analytical Project, St. John's Research Institute in Bangalore, you will be responsible for interacting with patients, sponsors, IEC, lab staff, and other departments to conduct studies following ICH GCP Guidelines, SOPs, and study protocol guidelines. You will act as the main communication line between patients, Investigators, and CROs during study conduct activities. **Key Responsibilities:** - Coordinate in screening, Audio-Video consenting, enrolment, periodic study visits, and close out visits. - Ensure the protection of the rights and well-being of research participants throughout the study duration. - Coordinate with finance, legal, and regulatory...
Posted 2 months ago
2.0 - 6.0 years
0 Lacs
maharashtra
On-site
You should have a minimum of 2 to 3 years of Clinical Data Management experience. It is essential to have exposure to Study Start-up, Conduct, and Study Closeout. If you do not have experience in all three phases, you should have good exposure to a minimum of two phases. Hands-on experience with Rave (Medidata) or Veeva EDC is a must. You must possess the following skills: - Setup experience with knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, and UAT knowledge (not mandatory). - Conduct experience including Data Cleaning (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/...
Posted 4 months ago
2.0 - 6.0 years
0 Lacs
maharashtra
On-site
You have 2 to 3 years of minimum Clinical Data Management experience. You must have exposure to Study Start up, Conduct, and Study Closeout. If you do not have experience in all three phases, you should have good exposure to a minimum of two phases. Hands-on experience with Rave (Medidata) or Veeva EDC is a must. In terms of setup, you should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, and some understanding of UAT (User Acceptance Testing) although it's not mandatory. Your experience in conducting tasks should include Data Cleaning, Query Handling, Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO ...
Posted 4 months ago
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