Director, Clinical Operations

Responsibilities

• Leads Certara Clinical Operations and Study Management activities.
• Leads CRO/vendor selection process for outsourced activities, including development of scope of services agreements, budgets, plans and detailed timelines.
• Works with Certara team and sponsors to select CROs, train investigators and investigative site staff, preparation of materials for investigator meetings, and clinical supplies as applicable.
• Participate and prepare for regulatory and/or client audits when scheduled.
• Led (or is a member of) Certara's study management team (SMT).
• Drives (or supports SMT lead) in the development and review of study planning to meet client objectives (including timelines, metrics, and budgets).
• Responsible for providing sponsor oversight of Phase 1 clinical study conduct (start-up through database lock and reporting), including review of study documents and coordinating cross-functional efforts to achieve study objectives and goals with a focus on quality.
• Ensures sponsor and CRO aspects of clinical studies run by Certara on behalf of clients are conducted in compliance with SOPs, Agency regulations, ICH/GCP guidelines and applicable local laws.
• Provides oversight of activities associated with the implementation, management and oversight of clinical trials.
• Provides training to internal and external customers as needed.
• Participate and provide expert clinical operations input into the writing of key clinical study documents including protocols and amendments, Informed Consent Forms, Investigator Brochures (IB) and Investigational New Drug Applications (INDs), providing guidance on operational and logistical issues.
• Identifies and communicates in a timely manner study issues that will impact budget, resources and timelines.
• Reviews and critiques case report forms/eCRFs for accuracy and completeness.
• Oversees data discrepancy management and assists with mapping as needed.
• Manages all aspects of vendor relationships to achieve project goals and ensure that performance expectations are met.
• Manages vendor agreements, change orders and site budgets to meet clinical operations specifications.
• Reviews and approves invoices for accuracy compared to work known to be performed by the vendor.
• Ensures that supportive study documents are completed with a focus on quality.
• Aid in the preparation of clinical study reports.
• Contribute to wider organizational goals and/or activities as assigned.

Qualifications

• Bachelor's degree required; science base education preferred; minimum of fifteen years related experience in the CRO, pharmaceutical or biotechnology industry, including at least 5 years of early development, Phase I CPU experience preferable.
• Previous experience managing direct reports is a plus.
• Self-starter with expertise in Phase 1 drug development, operations, and strategic planning.
• Effective leadership skills and ability to foster team productivity and cohesiveness.
• Experience leading multi-disciplinary teams and mentoring clinical team members.
• Knowledge of clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
• Experience managing Clinical Trial Supply in collaboration with manufacturer and CRO.
• Experience developing or reviewing SOPs.
• Experience managing CROs, central laboratories, and other clinical vendors.
• Experience managing contracts (vendor and site) and finance activities.
• Knowledge of data management, data review/analysis, and pharmacovigilance requirements.
• Ability to solve complex problems and manage multiple tasks simultaneously.
• Strong communication and interpersonal skills.
• Self-motivated with strong attention to detail and analytical problem-solving skills.
• Ability to write clearly and summarize information effectively.
• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint, MS Project, Teams) and SharePoint.
• Familiarity with project planning tools and task dependencies.