Company

REV Clinical (formerly CBCC Global Research)

Position

Principal Clinical Data Manager

Location

On-site and/or Remote

Website www.revclinical.com

COMPANY BACKGROUND

REV Clinical (formerly CBCC Global Research), headquartered in Bakersfield, California with additional operations in Ahmedabad, India, is a leading, multi-national clinical contract research organization with deep experience in designing and managing clinical trials across a range of therapeutic areas, including Oncology, CNS, and Ophthalmology. REV Clinical provides end-to-end CRO services spanning clinical study design, project management, data analysis, regulatory strategy and medical writing — across Phase I–IV clinical trials for leading biopharmaceutical companies.

ROLE: Principal Clinical Data Manager The Principal Clinical Data Manager provides Data Management leadership for one or more projects, ensuring timely and professional delivery of Data Management activities and consistently high-quality clinical trial data for analysis and reporting, in compliance with REV Clinical CDM SOPs. The role demonstrates a strong understanding of study protocols and their operational implications, and applies clinical database design, EDC, and regulatory expertise to drive successful execution of Data Management processes across the full study lifecycle — from start-up through database lock and study close-out.

KEY RESPONSIBILITIES

DM Leadership & Study Execution

- Provide timely and professional on-going management of Data Management deliverables and clinical trial data with respect to quality and timelines for assigned trials, in compliance with CBCC CDM SOPs
- Ensure consistently high-quality data is available for analysis and reporting
- Demonstrate a strong understanding of the protocol and its business and operational implications, applying this knowledge effectively to the successful execution of Data Management processes
- Provide oversight of Data Management activities throughout study start-up, conduct, database lock, and study close-out/finalization
- Demonstrate effective application of Data Management knowledge across a wide range of study and operational scenarios, including outsourced EDC development, paper and EDC-based studies, complex/multi-arm studies, and oversight of CROs and other Data Management vendors
- Manage effective execution of Data Management activities across one or more projects and lead the resolution of key issues escalated across projects
- Supervise and drive overall timelines/DM activities across one or more projects

Standards, Systems & Technical Expertise

- Develop and maintain robust CBCC-level standards (e.g., protocols, DMPs, Data Review & eCRFs/CCGs) and ensure adherence across projects
- Demonstrate expertise in clinical database design principles, EDC technology platforms, and the development and implementation of clinical data management solutions
- Demonstrate comprehensive knowledge of applicable industry standards and regulatory requirements, including ICH-GCP, CDISC, CDASH, and SDTM, and understand their impact on EDC development, data collection, data review, and downstream data processing




- Contribute effectively to the development and implementation of CRF standards and accompanying metadata, edit checks/validations, CCGs, and other data management standards
- Contribute effectively to the development of new CRF standards and accompanying metadata, edit checks/validations, CCGs, etc.
- Communicate and negotiate persuasively with other team members in all activities associated with the development of CBCC data standards

Quality, Risk & Compliance

- Consistently and efficiently monitor data trends that may signal potential fraud/misconduct, previously unrecognized quality concerns, or slippage in any aspect of study management
- Ensure appropriate tracking systems are kept up to date
- Develop risk management strategies to proactively prevent data quality issues from derailing projects
- Ensure team adherence to GCP, CBCC DM standards, SOPs, and applicable process & regulatory guidelines
- Effectively represent DM in SOP reviews and updates

Communication & Stakeholder Management

- Manage communication of project-wide DM status and team meetings
- Ensure DM associates on the projects are aware of the risks, priorities, goals, and impact of their work contribution
- May represent Clinical Data Management at cross-functional forums and meetings, providing timely feedback to partners

Resourcing, Training & Continuous Improvement

- Provide training, mentoring, and ongoing development of DM colleagues, and support the development of subject matter expertise within the team
- Drive effective use of resources through operational effectiveness and continuous improvement of the CBCC DM process
- Provide inputs for long-term training activities, ensuring the development of subject matter experts
- Lead and provide expert opinion/input into DM initiatives and innovations for quality, efficiency, and continuous improvement in scientific and operational excellence
- Support resource forecasting and efficient allocation of Data Management resources across projects, considering project priorities, timelines, complexity, and business needs
- Plan appropriately with Manager to ensure adherence to timelines, identify and propose solutions to address resource and timeline issues, and set priorities within the group
- Lead or support special projects within CBCC DM activities

People Management Responsibilities (if assigned)

- Assist in ensuring provision of timely, efficient, and high-quality Data Management deliverables for projects within the remit of assigned DM staff
- Track and request appropriate resources for assigned project(s) in line with organizational priorities to meet Clinical Data Management deliverable timelines
- Report to DGM-CDM regarding any additional resource demands

MUST-HAVE REQUIREMENTS

- Bachelor's degree in life sciences,



health sciences, clinical research, technology, or another relevant discipline
- Minimum 10 years of progressive clinical data management experience, including substantial experience as a Lead Clinical Data Manager for complex clinical trials
- Demonstrated end-to-end leadership of clinical data management activities from study start-up through database lock and study close-out
- Expertise in clinical database design, EDC platforms, eCRF development, metadata, edit checks, data validation, Data Management Plans, and clinical data review
- Comprehensive knowledge of ICH-GCP, CDISC, CDASH, SDTM, applicable regulatory requirements, and their impact on data collection and downstream data processing
- Proven ability to interpret protocols and translate clinical and operational requirements into effective data management solutions
- Experience managing multiple or complex studies, project timelines, data-quality risks, issue escalation, and database-lock readiness
- Demonstrated experience overseeing CROs, vendors, or outsourced EDC and data management activities
- Strong risk-management, analytical, problem-solving, prioritization, negotiation, and stakeholder-management capabilities
- Proven ability to communicate DM status, risks, dependencies, resource requirements, and mitigation plans to cross-functional stakeholders
- Demonstrated commitment to SOP compliance, quality management, continuous improvement, mentoring, and development of DM colleagues

NICE-TO-HAVE REQUIREMENTS

- Master's degree or relevant advanced professional qualification
- Multi-regional or global clinical trial experience
- Experience across multiple therapeutic areas and phases of clinical development
- Experience establishing organizational CRF, metadata, database-build, edit-check, or data-review standards
- Experience with DM process transformation, automation, operational metrics, dashboards, or technology-enabled quality monitoring
- Experience supporting audits, inspections, or regulatory submissions
- Relevant certification in clinical data management, clinical research, quality, or project management
- Experience representing Clinical Data Management in senior cross-functional, sponsor, or governance forums
- Formal people-management experience where the position includes direct reports

SKILLS/ABILITIES

- Strong leadership and ability to drive Data Management execution across one or more concurrent projects
- Excellent analytical, problem-solving, and risk-management skills
- Senior-level written and verbal communication, negotiation, and stakeholder-management skills
- Ability to mentor, train, and develop team members and support subject matter expertise growth
- Strong organizational skills with the ability to manage competing priorities and timelines across projects
- Sound judgment in escalating and resolving data quality or operational issues
- Adaptable and flexible to changing project priorities and study complexity

COMPENSATION An attractive compensation package comprised of a base, bonus and equity structure commensurate with this senior-level role will be provided.

📌 Principal Clinical Data Manager (Ahmedabad)
🏢 REV Clinical
📍 Ahmedabad