The Clinical Data Coordinator will participate in various clinical data management activities required to ensure that data captured in clinical trials undertaken, or managed by Indero, are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines.
This role will be perfect for you if:
• You have strong analytical capacities and an ease to work with data.
• You enjoy working with systems and technology, continuously learning.
• You want to work in a collaborative team where your ideas are heard and valued.
RESPONSIBILITIES
-Provides general data management support to the project team, sponsor and external vendors, as needed.
-Supports Lead Data Manager in the areas of:
• Data Review.
• Data Reconciliation.
• Discrepancy Management.
• Maintenance of Study Metrics; Monitoring study status (e.g. enrollment,
CRFs monitored/approved, etc.) on an ongoing basis and provide data status reports to the project team, as needed.
• Generation of Ad-Hoc Study Reports.
• User Maintenance.
• Assisting with User Acceptance Testing.
• Assisting with designing of database.
• Assisting with creating data management plan (DMP), and other clinical data management related documentation.
• Assisting in ensuring that data management documentation is complete and up-to-date in the trial master file (TMF).
Requirements
IDEAL PROFILE
Education
• B.Sc. or related field;
Experience
• 1 year of clinical data management experience in the pharmaceutical industry or in a CRO setting is considered an asset;
• Experience using an EDC system (ie. Medidata Rave, Medrio) is considered an important asset.
Knowledge and skills
• Skilled in use of computer technology, and ability to learn new applications;
• A general k
📌 Clinical Data Coordinator (Pune)
🏢 Indero
📍 Pune