Clinical Data Manager I
Job ID: ATR2105
Location: Bengaluru, Karnataka, India
Job Type: Full-time (On-site)
Department: Data Management
Overview
Quanticate, a world-leading data-focused CRO, is seeking a Clinical Data Manager I to lead and coordinate all aspects of Clinical Data Management (CDM) from study initiation to completion. This role requires strong project management, regulatory knowledge, and leadership to ensure high-quality data delivery for complex clinical trials.
Key Responsibilities
Clinical Data Management
Ensure launch, delivery, and completion of CDM procedures in line with contracts, SOPs, guidelines, and regulatory requirements.
Manage Case Report Forms (CRFs) and all related CDM tasks.
Perform medical coding activities when assigned.
Contribute to SOP creation, review, and continuous improvement of in-house CDM strategies and systems.
Maintain consistency of processes and quality across projects.
Project Management
Plan and manage study timelines and resources for allocated projects.
Monitor progress against schedules and provide updates to management.
Coordinate CDM activities across all functions to ensure seamless project execution.
Staff & Team Management
Allocate projects to staff in collaboration with Project Management.
Conduct performance reviews and oversee training and professional development of team members.
Administer staff development programs as required.
Stakeholder Management
Act as the primary CDM contact for both internal teams and external clients.
Manage client relationships and ensure effective communication throughout the study lifecycle.
Collaborate with data processing and programming teams to deliver high-quality project outcomes.
Key Relationships
External clients (primary contact for CDM projects).
Internal CDM leadership, data processing, programming, and project management teams.
Direct reports (line management, training, and performance appraisal).
Requirements
Education
Bachelor’s or Master’s degree in Life Sciences or related discipline.
Experience
6–8 years of relevant experience in Clinical Data Management within a CRO, including leading clinical studies.
Proven CDM project leadership experience.
Skills & Knowledge
Strong knowledge of at least two CDM systems (e.g., Oracle Clinical, Medidata Rave, Inform).
In-depth understanding of ICH Guidelines and Good Clinical Practice (GCP), especially regarding data handling.
Excellent communication and client relationship management skills.
Solid knowledge of pharmaceutical industry practices and clinical trial requirements.
Benefits
💰 Competitive salary (open to discussion based on experience).
⏰ Flexible working hours.
🏖️ Paid leave: Annual Leave, Sick Leave, Casual Leave, and Bank Holidays.
🏥 Medical insurance for self and immediate family.
🎗️ Gratuity & accidental coverage.
📚 Career development opportunities: mentoring, coaching, e-learning, and job shadowing.
About Quanticate
Quanticate partners with global pharmaceutical leaders and biotech innovators to support complex clinical trials requiring advanced statistical programming, data management, and biostatistics expertise. We are committed to career growth, offering memberships in professional societies, mentoring, and development opportunities to help you advance in clinical research.
⚠️ Note: Quanticate will never request payments as part of recruitment. All legitimate correspondence will come from @quanticate.com domain.
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