Director of Data Management

We are seeking a highly motivated and experienced Director of Data Management to lead our Data Management Department. This key leadership role is responsible for overseeing all data management activities, ensuring high standards, and promoting innovation through the introduction of digital technologies and effective processes.
This is full home based role in one of the European countries where OPIS has it's affiliate.

Key Responsibilities:

• Oversee all data management activities to ensure they meet contractual requirements, SOPs, and relevant regulations.
• Ensure the timely and high-quality delivery of data management services to clients.
• Design and implement processes to enhance department efficiency, positioning the company as a trusted, data-driven CRO.
• Provide strategic leadership and direction for Data Management personnel to meet organizational goals.
• Oversee resource allocation, staffing, and project deliverables for the department.
• Drive process improvement and ensure inspection readiness by overseeing the development of all data management documentation.
• Engage with internal and external stakeholders, including participating in strategy meetings, client engagements, and project kick-offs.
• Collaborate with ICT and other departments on data management tools, EDC systems, and resource management.
• Ensure project costs, timelines, and invoicing are aligned with business objectives and client expectations.
• Lead CAPA management activities and oversee audits, inspections, and corrective actions.
• Develop and maintain SOPs and ensure the department’s adherence to them.
• Define and track KPIs to guarantee excellent performance and timely deliverables.
• Ensure the successful management and development of Data Management personnel through mentorship, training, and performance reviews.

Qualifications:

• Degree in clinical, biological sciences, or a related field.
• 10+ years of experience in CRO/pharmaceutical/biotechnology industries.
• 5+ years of leadership experience in Data Management, including global team oversight.
• Strong knowledge of data management systems, FDA regulations, and global industry standards.
• Expertise in EDC systems and digital data collection tools.
• Excellent leadership, communication, and client management skills.

We offer a competitive salary and benefits package as well as opportunity to be part of a company that values growth, innovation, and customer success. 

Please read the information notice on the processing of personal data in the candidates information section of our company website.

Who we are:

OPIS is an International CRO with over 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.

OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.

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