Job Title: Associate Clinical Data Manager (EDS)
Location: Bangalore
Category: Data Management & Data Science
Job ID: 253042
The Associate Clinical Data Manager (EDS) provides leadership on clinical data management (DM) activities, taking responsibility for project documentation, system setup, data entry, and validation processes. The role oversees all DM activities from study start-up to database lock, ensuring quality, timelines, and budgets are met. The position involves direct client interaction to understand requirements and implement solutions while mentoring junior staff.
Study Leadership & Management
Lead studies involving healthy volunteers and patient populations, multi-site, or client-managed studies with reduced timelines.
Organize and prioritize workload and deliverables effectively.
Ensure all DM deliverables meet established timelines and quality standards.
Provide instruction and review outputs of the DM study team, adjusting resources as needed.
Project Coordination & Compliance
Ensure all allocated projects comply with relevant protocols, global SOPs, and GCP standards.
Collaborate with Project Managers to build study timelines and coordinate cross-functional teams.
Lead data-focused internal project meetings and coordinate with EDC Design, SAS Programming, Statistics, and PK teams.
Identify potential risks, propose mitigations, and communicate progress to Project Managers.
Client & Stakeholder Management
Maintain client relationships and review satisfaction surveys.
Track scope changes and ensure sponsor approval for all changes.
Represent DM or Biometrics in client interactions, audits, and business opportunities.
Team Leadership & Mentorship
Provide leadership, coaching, and mentorship on DM processes to the internal study team.
Support DM managers in performance evaluations and professional development of team members.
Data Management & Technical Oversight
Reconcile clinical databases with safety, laboratory, or third-party data.
Utilize laboratory systems and batch data load facilities as appropriate.
Keep up to date with DM technologies and suggest process improvements.
Other Duties
Attend and address client/internal audits.
Promote Biometrics services to sponsors.
Perform additional duties as assigned.
Minimum Requirements
University/college degree (or equivalent experience considered).
Fluent in English (written and verbal).
6–8 years of DM experience with at least 1 year of direct sponsor management.
Knowledge of clinical trial processes, DM, clinical operations, biometrics, and system applications.
Strong time management, organizational, and interpersonal skills.
Preferred Qualifications
Degree in life sciences, health sciences, IT, or related field.
Scientific knowledge or background preferred.
3+ years of Electronic Data Capture (EDC) experience.
Familiarity with Fortrea structure and SOPs.
Office and home-based work environment.
May require overtime or weekend work.
Flexible shifts as per business requirements.
Leadership and team management
Cross-functional collaboration
Client relationship management
Risk identification and mitigation
Attention to detail and quality compliance
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