Senior Clinical Data Manager

Role Overview

• Serve as the primary study‑level Data Management (DM) lead or co‑lead, providing strategic direction for all DM activities.
• Provide day‑to‑day oversight and guidance to Clinical Data Managers, Clinical Data Coordinators, and/or Data Associates.
• Lead internal study team meetings and contribute to sponsor meetings, including Study Kick‑Off and routine governance meetings.
• Track study progress, identify risks, and implement corrective and preventive actions as needed.
• Support financial oversight by monitoring study budgets for DM activities, tracking effort and deliverables against the Scope of Work (SOW), identifying potential out‑of‑scope tasks, and escalating budget-impacting variances as appropriate.
• Perform and oversee regular data cleaning activities to ensure timely, high‑quality, audit‑ready data.
• Ensure all DM deliverables meet internal quality standards, regulatory expectations, and contractual timelines.
• Coordinate data review cycles, query management activities, and data reconciliation tasks with cross‑functional partners.
• Review data listings, reports, and metrics to ensure consistency, accuracy, and completeness.
• Ensure compliance with all relevant SOPs, work instructions, regulatory guidelines, and sponsor requirements.
• Participate in internal and external audits/inspections and lead DM preparation and responses where required.
• Ensure completion of all assigned trainings and SOP reading tasks within required timelines.
• Support and, with guidance, oversee the implementation of new technologies, database updates, and system enhancements.
• Collaborate with the programming teams to enhance efficiency, streamline processes, and support innovation initiatives.
• Provide functional input to database specifications, edit checks, data review tools, and system validation activities.
• Support onboarding and training of new joiners within the Data Management function.
• Foster strong, collaborative communication with the Line Manager, cross‑functional colleagues, and other study stakeholders.
• Provide mentorship and serve as a subject‑matter resource for team members on complex DM tasks.
• Perform other duties as assigned by the Line Manager to support departmental goals and study success.

Requirements

• A minimum of 6 years of hands‑on experience in the Clinical Data Manager project lead role, preferably in global Phase II–III oncology trials, with a CRO background.
• Proven end‑to‑end data management lifecycle expertise, including database build, data cleaning, medical coding, SAE reconciliation, data review, and database lock.
• Demonstrated experience overseeing or mentoring team members, with a focus on quality, efficiency, and accountability.
• Strong understanding of CDISC standards (SDTM), ICH‑GCP, regulatory requirements, and industry best practices.
• Experience working with leading EDC systems (e.g., Medidata Rave, Inform, Veeva, or equivalent), including database updates and UAT processes.
• Demonstrated ability to thrive under pressure and manage multiple priorities effectively.
• Advanced problem‑solving skills and a proactive, solution‑oriented approach to challenges.
• Proven ability to plan, coordinate, and organize complex tasks with precision and attention to detail.
• Strong team‑collaboration and conflict‑resolution skills, with the ability to address issues constructively and professionally.
• A consistent track record of delivering high‑quality, accurate outputs within agreed timelines.
• Exceptional flexibility and adaptability, with the ability to navigate evolving study needs and dynamic environments.
• Experience contributing to budget tracking or financial oversight within study operations is beneficial.
• Strong communication and interpersonal skills, with the ability to convey complex data concepts clearly to both technical and non‑technical stakeholders.
• Ability to work independently and proactively, including in remote or distributed team environments, while remaining an engaged and supportive team player.
• Flexible and adaptable approach to work, able to adjust to evolving priorities, study timelines, and sponsor needs.
• Excellent organizational skills and meticulous attention to detail, combined with a strong sense of ownership and a “getting the job done” mindset.
• Client‑focused attitude, demonstrating professionalism, accountability, and a commitment to delivering high‑quality outputs on time.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint) and a strong willingness to learn new software, systems, and data‑related tools.
• Cultural awareness and sensitivity, with the ability to collaborate effectively across diverse, global teams and time zones.

Tech Stack

• Google Cloud Platform

Benefits

• Flexible working hours
• Remote work options