Senior Director, Strategic Clinical Data Management

Remote Worker LTD.; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Worldwide Clinical Trials is seeking a senior leader to oversee the Data Management department, ensuring timely, accurate deliverables and strict regulatory compliance across projects. You will guide a team to meet sponsor requirements and drive quality in data management processes.

You will manage managers, optimize resources and budgets, develop SOPs, and lead process improvements while mentoring staff and partnering with stakeholders to deliver high-quality data for clinical trials.

Qualifications

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline — or equivalent relevant experience.
• Min of 12 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.
• 6-8 years of line management experience.

Responsibilities

• Ensure that all operations carried out by department are conducted to applicable regulations, GCP, Worldwide SOPs and guidelines, and to the requirements of the sponsor.
• Provide line management for assigned management team.
• Define and monitor objectives for assigned Managers, ensuring there are opportunities for career and personal development.
• Contribute to the strategic management of the department.
• Oversee resourcing for assigned team ensuring proactive and strategic assignment of resources.
• Oversee departmental quality and issue management by proactively identifying trends and initiation of strategic solutions.
• Manage overall departmental project deliverables by proactively reviewing project status and establishing mitigation plans.
• Proactively monitor and manage project profitability and overburn/underburn for department projects.
• Oversee Subject Matter Experts to ensure effective process oversight.
• Provide departmental oversight of projects and representation to internal and external stakeholders for support on strategic planning, oversight, risks and mitigations.
• Develop and implement department SOPs.
• Lead and manage the development of new departmental process improvement and efficiency initiatives.
• Perform other duties as assigned.

Skills

Attention to detail

Written & verbal communication

Data management best practices

Communication & interpersonal

Clinical trial process knowledge

Analytical & problem solving

Project management

Line management experience

Education

Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline

Job description

Worldwide Clinical Trials is seeking a senior leader to oversee the Data Management department, ensuring timely, accurate deliverables and strict regulatory compliance across projects. You will guide a team to meet sponsor requirements and drive quality in data management processes.

You will manage managers, optimize resources and budgets, develop SOPs, and lead process improvements while mentoring staff and partnering with stakeholders to deliver high-quality data for clinical trials.