The Clinical Data Manager will lead and manage clinical studies, ensuring that data 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.
As a Clinical Data Manager, you will ensure that data captured in multiple clinical trials undertaken or managed by Indero is collected, managed, and reported clearly, accurately and securely.
More specifically, the Clinical Data Manager must:
Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time.
Be the data management liaison to the project team, sponsor and external vendors, as needed.
Manage up to three studies, based on study complexity,
with some support from manager.
Attend meeting with sponsor and answers Data Management related question.
Monitor timelines and scope of work to ensure timely and within budget completion of assigned tasks
Be responsible for the development of electronic case report form (eCRF) specifications (including data capture screens and edit check specifications) needed to build a study-specific clinical database/electronic data capture (EDC) system.
Be responsible for or assist in the programming and ongoing maintenance of the clinical database.
Be responsible for the validation and testing of the clinical database (e.g. User Acceptance Testing).
Be responsible for the development of eCRF completion guidelines and other training material required to train site users and monitors.
Conduct training for site users/monitors on the clinical database.
Develop data transfer agreements and specifications with vendors providing external data (e.g. laborato
📌 Clinical Data Manager-India (Pune)
🏢 Indero
📍 Pune