Position Responsibilities

• Ensure consistency in the implementation of clinical project plans by providing reviews and support template development or refinement.
• Lead initiatives, create process/ standards, and ensure consistency, communication, and change management across Clinical Operations, specifically related to SOP and work instruction creation and management, outsourcing, and compliance.
• Partner with cross-functional team members within Regulatory, Quality, Data Sciences, Clinical Research, Pharmacovigilance, and other key cross-functional groups to support department compliance objectives.
• Develop TMF standards and oversight in support of inspection readiness Develop or refine Standard Operating Procedures (SOPs), vendor endorsement team process, and functional builds, e.g. TMF standards.
• Support outsourcing partnerships through issue escalation, resolution, and CAPA mediation and documentation as a support to governance oversight.
• Provide compliance oversight of clinical operation activities (trial management, site monitoring, vendor management, TMF, data operations, IMP management, and closeout activities, etc.) for clinical trials.
• Review key documents in conjunction with other functional area leads (e.g. protocols, SOPs,  project plans, and inspection requests, etc.).
• Serve as the Clinical Operations compliance subject matter expert for SOPs, GCP, ICH, FDA, EMA, and other applicable regulatory requirements, ensuring practical application/compliance across study teams and vendors throughput the trial lifecycle.
• Issue escalation, documentation, and resolution in partnership with Clinical Operations and Quality Assurance business practices.
• Ensure consistent implementation of training and learning, including responsibility for managing functional training matrices and adherence by personnel, as well as oversight of vendor training and learning processes.
• Contribute to global clinical / regulatory submissions.
• Responsible for assisting in inspection readiness activities, including mock and site inspections.
• As a subject matter expert, actively educate, engage with and seek input from key stakeholders to bolster organizational effectiveness and efficiency.
• May require travel, including international travel.
• Flexible to support in-office days.

Candidate Requirements

• Bachelor’s Degree (scientific discipline preferred); advanced degree preferred 
• Minimum 8 years of experience in a biotech/pharmaceutical/ CRO setting; minimum 6 years of clinical operations experience; minimum 3 years in a supervisory role
• Proven record of success supporting complex drug development trials, including inspection readiness preparation and experience with positive outcomes from inspections
• Demonstration of effective leadership through vision for her/his team, coaching and mentoring, and organizational development
• Highly organized, outcome oriented, self-motivated performance
• Comfortable in a fast-paced environment with the ability to adapt to change
• In depth knowledge and understanding of all aspects of clinical trials
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
• Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
• Excellent knowledge and experience with federal regulatory requirements and guidelines for Good Clinical Practice
• Outstanding oral and written communication skills including authoring and driving the development of SOPs and other key trial documents