Manager Biometrics

**Are you the manager ready to take our data teams to the next level? At CHDR we’re looking for a Manager Biometrics who actively wants to contribute to the growth and development of our organization, and specifically our data processes. In this role you play an important part in streamlining our data collection and analyses during and after our clinical studies. You will be responsible for three teams who need to align their processes efficiently: Clinical Programming, Data Management and Statistics. Additionally, you’ll be working closely with other teams that are part of CHDR’s Clinical Operations and Science departments, as well as our customers and external vendors. The teams are spread across two locations at the Leiden Bio Science Park.**

**Who are we?**:
The Centre for Human Drug Research (CHDR) is a foundation based at the Leiden Bio Science Park. Since its establishment in 1987, CHDR has grown into a globally recognized innovative institution in the field of clinical drug development. We conduct dozens of studies annually, involving healthy volunteers and patients. We work closely with university medical centers, large hospitals, pharmaceutical companies, and scientists worldwide. We have about 300 permanent colleagues and more than 100 on-call workers who help us and gain work experience. CHDR has the ambition to grow significantly in the coming years.

Within CHDR, there are three teams focused on clinical research data:

- **Data Management**:Responsible for collecting, organizing, and managing all data obtained during clinical studies, ensuring adherence to strict protocols and maintaining data accuracy and integrity throughout the entire data lifecycle;
- ** Clinical Programming**: Designs and maintains study databases to securely store and manage research data. This team also supports data cleaning using programmed checks, imports (external) data into the clinical database, manages data transfers to clients, oversees ADaM and SDTM data conversion, and conducts post-study safety analyses;
- **Statistics**:Delivers expert scientific input on study design, synopsis, and protocol reviews. The team manages randomization, develops statistical analysis plans, and handles interim reporting. They analyze collected data to identify trends, patterns, and statistical significance, which is essential for scientific interpretation and decision-making. Additionally, they review and contribute scientific insights for clinical study reports and manuscripts.

For programming, these teams use SAS; the study databases are set up in the protocol management system Promasys®.

**What is your role as Manager Biometrics?**:
**Team integration**:
You will be responsible for streamlining the operations of our three core teams, which already collaborate closely on collecting and analyzing study data. We seek someone who can further enhance this collaboration, foster integration, and develop these teams into a unified, high-performing unit. Strengthening partnerships with other CHDR teams will also be a key focus.

**Process Quality**:
You ensure that all processes related to data collection and analysis run efficiently and comply with applicable laws and regulations (e.g. GDPR and GCP) and industry standards (EMA, FDA, GAMP5, ALCOA++, and ICH guidelines).

**Capacity Planning**:
You are responsible for overseeing the capacity across the teams, ensuring that resources are efficiently allocated to meet the demands of contracted projects and support anticipated growth (long-term).

**Client Focus**:
As CHDR operates in a competitive international market with demanding clients, maintaining a high level of service and quality is crucial. As the Manager Biometrics, you will be attuned to client needs and expectations, ensuring that deadlines are met, deliverables are of high quality, and client interactions are professional and positive. You are solution-oriented and actively manage expectations with all stakeholders.

**People Development**:
You are passionate about developing your team and its ambitious members, in line with CHDR’s commitment to education and growth. You will mentor team leads and understand the importance of being a distinctive employer, especially given the increasing competition for highly skilled professionals at the Leiden Bio Science Park. You ensure that the teams are developing in line with industry trends, regulations and best practices.

**Innovation**:
You stay informed about emerging trends and technologies, actively seeking opportunities to integrate innovations into Biometrics processes. This could include leveraging AI for data management and reporting, or implementing other quality improvement initiatives.

**Project Management**:
You play an active role in furthering the alignment with several teams within the department of Clinical Operations (which your teams are also part of). Furthermore, you’ll be part of different project groups with a company-wide focus, contributing to