Director, Site Start-Up Leadership

Precision for Medicine; United States; À distance; USD 180 000 - 280 000; Plein temps

Résumé du poste

Precision for Medicine is seeking a Director of Site Start Up to provide leadership for the SSU department and shape its strategy, people, processes and systems. You will ensure SSU delivery and client satisfaction across regulatory submissions, budgets and start-up activities globally or regionally.

The role requires extensive SSU experience, GCP/ICH knowledge, and strong communication and leadership abilities to drive continuous improvement and growth within PfM's SSU framework.

Qualifications

• Bachelor's degree in life sciences or related field or equivalent combination of education, training, and experience.
• A minimum of 12 years in clinical research including extensive experience of Site Start-up.
• Extensive leadership experience or proven competencies for this position.
• Expert knowledge of GCP/ICH guidelines and the clinical development process.
• Fluency in English.

Responsabilités

• Provide SSU team with guidance, leadership and support relating to SSU project delivery and people.
• Oversee SSU delivery across IRB/EC submissions, CA submissions, site contracts and budgets.
• Develop SSU framework, tools and KPIs with the Head of Site Start Up; manage risk evaluations and mitigations.
• Collaborate with Clinical Operations and cross functional teams for SSU planning and governance.
• Drive SSU strategy with global/regional leaders and support client meetings and proposals.

Connaissances

Leadership

Communication

Interpersonal skills

Fluency in English

Formation

Bachelor's degree in life sciences

Outils

Microsoft Office

CTMS

eTMF

EDC

Description du poste

Precision for Medicine is seeking a Director of Site Start Up to provide leadership for the SSU department and shape its strategy, people, processes and systems. You will ensure SSU delivery and client satisfaction across regulatory submissions, budgets and start-up activities globally or regionally.

The role requires extensive SSU experience, GCP/ICH knowledge, and strong communication and leadership abilities to drive continuous improvement and growth within PfM's SSU framework.