Job purpose
The Senior Clinical Data Manager is responsible for leading and overseeing end‑to‑end clinical data management activities for a global study, ensuring high‑quality, timely, and compliant data deliverables. This role provides operational oversight to Clinical Data Managers, Data Coordinators, and/or Associates, supports training of new team members, and collaborates closely with cross‑functional stakeholders to drive data accuracy, process efficiency, and continuous improvement.
The Senior CDM will serve as the primary study-level data management contact or co-lead, ensuring adherence to internal standards, sponsor expectations, and regulatory requirements throughout the full data lifecycle. In addition, the role contributes to financial oversight, supporting budget tracking, identifying scope changes, and ensuring alignment between operational activities and contracted deliverables.
Responsibilities
The responsibilities for the Senior Clinical Data Manager include, but are not limited to, the following:
- 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.
- Support financial oversight by monitoring DM‑related budget components, tracking scope, and flagging potential out‑of‑scope activities.
- 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.
Why us?
You will join a young, very dynamic, and fast-growing private research organization. Our passionate, truly multicultural, and diverse team of nearly 500 colleagues and nearly 40 nationalities include epidemiologists, clinical operations, CRAs, CTAs, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and business support professionals spreading over 20 countries.
We all work remotely, setting our own time schedule, based on a “getting the job done” mentality. This has a positive impact in our work-life balance. Our headquarters are in Leuven (Belgium), but we also have local and regional offices located in Rotterdam and Zeist (the Netherlands), Bogota (Colombia), Johannesburg (South Africa), Bangkok (Thailand), Paris (France), Casablanca (Morocco) as well as Marietta and Durham (United States). You may need to travel occasionally.
At P95, we are a collaborative and international team that works on diverse projects, topics, and clients and faces interesting challenges. There is a high level of empowerment, flexibility, autonomy as well as opportunities for research and development, to make things happen. We have an open culture of respect and inclusion. Consequently, we value self-reliance, initiative, and responsibility of everyone in our team to meet our internal and external customers’ expectations. Finally, our colleagues experience a strong sense of meaning and purpose driven by the scientific nature and impact of our work.
About us
P95 and Julius Clinical have recently joined forces, bringing together two highly complementary organizations with a shared mission: advancing global health through high‑quality epidemiological research and clinical trials.
P95, founded in 2011 and headquartered in Belgium, is a global leader in epidemiology, vaccines, and infectious disease research. With offices across Europe, North America, South America, Africa, and Southeast Asia, P95 supports public health agencies, pharmaceutical companies, academic institutions, and global organizations such as WHO and the European Commission. Our work focuses on generating timely, pragmatic, and actionable insights to improve access to safe and effective vaccines.
Julius Clinical, founded in 2008 and based in Zeist, The Netherlands, is a leading clinical CRO known for its strong scientific leadership and operational excellence. With more than 400 clinical trials conducted and over 300,000 participants enrolled worldwide, Julius Clinical specializes in central nervous system, cardio‑metabolic, renal, and rare diseases, working closely with biotech and mid‑sized pharma partners.
Together, we form a global, science‑driven organization offering an integrated portfolio of epidemiological and clinical research services. Our teams combine deep scientific expertise, operational excellence, and a shared passion for improving healthcare outcomes.
P95 and Julius Clinical are part of the Ampersand Capital Partners portfolio, a healthcare‑focused private equity firm.
We are united by a commitment to scientific rigor, innovation, and meaningful impact and we are excited to welcome new colleagues who share our ambition to improve global health.
