Senior Clinical Data Manager

Julius Clinical; Zeist; Hybrid; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Innovative work environment

Flexible working hours

Opportunity for creativity

Job summary

A healthcare research organization in Zeist seeks a Senior Data Manager to lead and mentor a team in ensuring data integrity, compliance, and innovation within clinical study projects. The ideal candidate will have at least 5 years of experience in Data Management, preferably in the Food, Health, or Clinical Research sectors. This position offers the flexibility of remote work and an open culture that encourages creativity and direct influence on processes.

Qualifications

• At least 5 years of relevant Data Management experience, ideally in Food, Health, or Clinical Research.
• Solid experience with data acquisition tools and/or analysis software.
• Knowledge of CDISC, SDTM, and RBQM is advantageous.

Responsibilities

• Represent Data Management in project teams and cross-functional initiatives.
• Manage and mentor Junior and Medior Data Managers.
• Ensure data integrity and compliance with regulations.
• Drive innovation and process improvements in Data Management.

Skills

Proactive mindset

Communication skills

Analytical skills

Data management experience

Knowledge of FDA and ICH GCP

Fluent in English

Education

Higher education degree in (bio)medical sciences or related field

Tools

CDMS

RTSM

ePRO/eClinRO

R software

Job description

Overview

Direct message the job poster from Julius Clinical

For our professional and fully-fledged Data Management team, which is part of the Digital Innovation and Clinical Services Department, we are looking for a communicative, proactive, and independent Senior Data Manager.

ABOUT THE TEAM

Our Data Management team is a diverse and international group of professionals, consisting of a Director Data Management, 14 EU-based and 6 US-based Data Managers at junior, medior, and senior levels. In this role, you will report directly to the Director Data Management and we encourage you to share your ideas in shaping the future of the department.

We encourage fresh ideas and give you the space to actively contribute to innovation and process improvements. You will have significant visibility within the organization by representing Data Management in study project teams across a variety of therapeutic areas. At the same time, you will be a trusted partner for colleagues, external stakeholders, and sponsors.

What you will do

• Represent Data Management in project teams, cross-functional company initiatives, and with external partners;
• Coach, mentor, and support Junior and Medior Data Managers, helping them grow in their roles;
• Act as primary contact for vendors (e.g. central laboratory, IMP) and sponsors;
• Design, manage, and deliver Data Acquisition Tools within agreed timelines and to the highest quality standards;
• Safeguard data integrity by overseeing collection, quality, and management processes in full compliance with SOPs and international guidelines;
• Maintain oversight of all Data Management activities within your projects, as described in the Data Management Plan;
• Drive innovation by leading process improvements (digital solutions, new ways of working, compliance with upcoming legislation and regulations);
• Translate the latest Data Management quality requirements into practical business processes (SOPs, WIs);
• Collaborate with IT to validate computerized data collection systems (CDSM, RTSM, ePRO/eClinRO);
• Prepare cost proposals for Data Management services and manage project budgets.

What you bring

• A higher education degree, preferably in (bio)medical sciences, computer science, or a related field;
• At least 5 years of relevant Data Management experience, ideally within the Food, Health, or Clinical Research sector;
• Solid experience with acquisition tools (CDMS, RTSM, ePRO/eClinRO) and/or analysis software (e.g. R);
• Expert knowledge of FDA, ICH GCP, GCDMP, and related regulatory requirements;
• Knowledge of CDISC and SDTM (advantage);
• Knowledge of RBQM (advantage);
• Fluency in English (Dutch is a plus);
• A proactive, independent, and process-oriented mindset, combined with excellent communication and analytical skills.

What we offer

An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions. An environment where you have room to be creative, take initiative and have direct influence on the way we work.

We are located in Zeist, close to public transport. Our employees have the flexibility combine working from the office with working from home.

How to apply

Interested in this position? Send your CV and motivation to [e-mail]

Questions

If you have any further questions, please contact Lotte Smets, Director Data Management ([phone]) or Ellen Hunink, HR Business Partner ([phone]).