Global Biometrics Delivery Lead

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee the implementation of the Data Operations strategy and the technological setup for Data Operations related to assigned projects and programs.

• Act as the main contact for Global Data Operations initiatives, collaborating with clients, functional leaders, and project stakeholders.

• Provide leadership across teams involved in database programming, data integration, data management, and statistical services across various regions.

• Develop and implement project timelines for Global Data Operations deliverables while coordinating dependencies among Data Management, Programming, and Biostatistics.

• Administer project budgets, resource allocation, and staffing needs, while tracking productivity and project advancement.

• Ensure that project activities adhere to quality standards, standard operating procedures (SOPs), ICH-GCP requirements, and relevant regulatory guidelines.

• Proactively identify project risks and assist in planning and resolving risk mitigation strategies.

• Support project initiation, study execution, closeout activities, audits, inspections, and maintenance of project documentation.

• Work in tandem with study teams and Data Standards Associates to uphold relevant data standards.

• Build working relationships with functional experts, providing leadership, guidance, and project direction.

• Track scope, timelines, deliverables, and project metrics to ensure that contractual obligations and business goals are met.

• Propel continuous improvement initiatives and contribute to operational excellence in project delivery activities.

⛳️ Requirements

• A bachelor's degree in a science-related field or equivalent qualifications.

• Demonstrated experience in applying project management principles.

• Proven track record of leading project teams in technical, programming, data management, or statistical settings with minimal supervision.

• Familiarity with cross-functional clinical development processes.

• Knowledge of standard operating procedures (SOPs), ICH-GCP guidelines, and relevant local and international regulations.

• Excellent written and verbal communication skills in English.

• Capability to work efficiently in global and culturally diverse teams.

• Over 10 years of experience in supporting data management, statistical programming, data integration, or biometrics functions within clinical development.

• Understanding of clinical trial systems and the role of technology platforms in supporting Data Operations delivery.

• Experience in participating in audits, inspections, or quality improvement projects.

• Familiarity with clinical data standards and their application in clinical trials.

• Willingness to travel domestically and internationally as required.

🏝️ Benefits

• Flexible remote work arrangement.

• Opportunity to impact clinical trial delivery and support innovative therapies.

• Engaging and fast-paced work environment.

• Diverse global team atmosphere.

• Opportunities to contribute to continuous improvement and operational excellence.