24 Aug
|
ProRelix Research
|
India
24 Aug
ProRelix Research
India
Role- Associate Team Lead
Department- Clinical Data Management
Reporting to- Senior Manager - Clinical Research Operations
Location- Pune ( Office – Based )
About ProRelix Research
ProRelix Research is clinical research organization (CRO) providing end-to-end clinical research
services to global clients. The company specializes in areas such as clinical data management, biostatistics, medical writing, and regulatory support. ProRelix is committed to delivering high-quality, compliant, and efficient solutions across the clinical research lifecycle.
ProRelix Research is an equal chance employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of gender, background, age, or belief.
Website: www.prorelixresearch.com
Role Purpose
To lead and manage all clinical data management activities across multiple clinical trials, ensuring high-quality, compliant, and timely delivery of data in accordance with regulatory requirements, SOPs, and project specifications.
Detailed Responsibilities
• Lead end-to-end clinical data management activities from study start-up to database lock and closeout
• Act as the single point of contact for multiple studies, coordinating with clients and cross-functional teams (Biostatistics, Programming, Medical, Safety, QA, Vendors)
• Ensure preparation, review, and maintenance of all clinical data management documents (DMP, CRF Completion Guidelines, Validation Plans, etc.)
• Manage client communication regarding timelines, deliverables, and project updates
• Maintain study files in an audit-ready state at all times
• Allocate, monitor, and review tasks for data management team members to ensure quality and timeline adherence
• Collaborate with internal stakeholders and functional leads to ensure smooth project execution
• Serve as escalation point for unresolved data issues and ensure timely resolution
• Ensure appropriate resource planning and allocation across projects
• Ensure com
📌 Associate Team Lead (India)
🏢 ProRelix Research
📍 India