P95

Senior Clinical Data Manager

P95

full-time

Posted on:

Location Type: Hybrid

Location: Remote • South Africa

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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.
Benefits
  • Flexible working hours
  • Remote work options
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
data management lifecycledatabase builddata cleaningmedical codingSAE reconciliationdata reviewdatabase lockCDISC standardsSDTMICH-GCP
Soft Skills
mentoringproblem-solvingteam collaborationconflict resolutioncommunicationorganizational skillsattention to detailflexibilityadaptabilityclient-focused