Director - Clinical Data Management
Company: SoTalent Agency
- Location: Copenhagen, Denmark
- Seniority: Director
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Director, Clinical Data Management
Location: Copenhagen, Denmark
Industry: Biotechnology | Pharmaceuticals | Clinical Research
Salary: DKK 854,240–1,281,360 gross annually
About the Role
An opportunity is available for an experienced Director of Clinical Data Management to oversee clinical trial data management activities within an international biotechnology organisation.
The role focuses on delivering accurate, high-quality clinical trial data, managing outsourced data management partners, and improving processes across clinical development programmes.
Key Responsibilities
- Lead and oversee end-to-end clinical data management activities across multiple clinical trials.
- Ensure consistent data management standards, quality, and regulatory compliance.
- Oversee clinical data collection, validation, cleaning, and database lock activities.
- Manage external CROs and data management vendors, including performance, budgets, and deliverables.
- Support vendor selection, qualification, contract reviews, and governance.
- Oversee Electronic Data Capture (EDC) systems, eCRFs, data validation plans, and clinical trial documentation.
- Ensure compliance with ICH-GCP, applicable regulations, and internal SOPs.
- Lead clinical data quality improvements, risk assessments, and audit readiness activities.
- Collaborate with Clinical Operations, Clinical Development, and cross-functional teams.
- Develop and improve data management processes, systems, and operational standards.
- Support clinical trial budgets, work orders, and vendor performance reviews.
- Contribute to departmental strategy and potentially lead and develop data management employees.
Required Skills & Experience
- Significant experience in Clinical Data Management within pharmaceutical, biotechnology, or clinical research environments.
- Strong understanding of clinical trial operations and ICH-GCP requirements.
- Experience overseeing outsourced clinical data management activities and CRO partnerships.
- Knowledge of EDC systems, clinical data validation, data cleaning, and database lock processes.
- Experience with clinical data quality management, audits, and regulatory inspections.
- Strong project management, stakeholder communication, and problem-solving skills.
- Ability to lead cross-functional initiatives and drive operational improvements.
- Experience developing or improving SOPs, processes, and data management standards.
Compensation & Benefits
- Annual salary: DKK 854,240–1,281,360 gross.
- Potential discretionary bonuses and long-term incentives.
- Pension contributions.
- Health insurance and wellness benefits.
- Paid time off and employee support programmes.
Additional Information
The position involves senior-level responsibility for clinical data management strategy, vendor oversight, and operational delivery. Direct people management may form part of the role depending on responsibilities assigned.
