Director of Global Regulatory Clinical Services

Proclinical is seeking a remote Director of Global Regulatory Clinical Services (GRCS) that will be accountable for the leadership and oversight of the trial master file and the safety alert reporting functions within global regulatory services and operations. The GRCS Director will set the vision, strategy and define organizational structure to deliver eTMF and SAR services consistent with global goals.

Job Responsibilities:

• Drive collaboration across Eisai business groups to ensure there is alignment across global TMF management as well as ensuring timely receipt of study start up and close out information for Safety Alert Reporting obligations.
• Serves as point of contact for regulatory inspections and audits collaborating with each function in providing responses to regulatory authorities. Identify and leverage external knowledge of industry best practices and processes, through knowledge of the DIA reference Model, ICH, GCP, EMA guidance and any other applicable TMF and Safety Reporting regulations.
• Ensure internal and external personnel are appropriately assigned eTMF user roles and permissions.
• Establish internal and external training standards and materials on the electronic systems for each function, ensuring all stakeholders receive appropriate training on current processes and systems.
• Run study dashboards and appropriately communicate metrics to ensure consistently maintained compliant eTMFs.
• Foster and advance relationships with key partners (internal and external stakeholders and suppliers).
• Vendor management, SOW, Work Order, contracts and budget management. Ensure optimal use of system functionality.
• Manage both US and UK based direct reports or team members, ensuring that regional requirements are followed.
• As a GRSO Leadership Team member, contribute to GRSO initiatives, vision and goals.

Skills and Requirements:

• Bachelor's degree
• Minimum of 10 years as a TMF expert in the pharmaceutical environment and familiar with Safety Alert Reporting requirements.
• Thorough knowledge of the DIA Reference Model, ICH, GCP, EMA, PMDA guidance and any other applicable TMF and SAR regulations.
• Experience in clinical trial document management in accordance with global regulations
• Experience with various electronic systems including TMF and SAR systems and vendor management.
• Solid expertise with inspections and inspection readiness.
• Must have a strong understanding of clinical development including global regulatory requirements for the conduct of clinical trials and related regulatory documentation and to be able to interpret and make decisions based on the interpretation of such guidelines.
• Excellent written, verbal, and interpersonal communication skills.

If you are having difficulty in applying or if you have any questions, please contact Eddie Emery at (+1) 619-573-6034 or e.emery@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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