Sr. Manager, Clinical Trial Operations

Role Summary

Sr. Manager, Clinical Trial Operations

Responsibilities

• Leads and coordinates the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.
• Detailed management and oversight of regional trial activities, as assigned.
• Effectively manages third-party suppliers to contracted deliverables within quality, cost, and timeline parameters.
• Effectively manages and/or assists with cross-functional clinical study team members to achieve deliverables with high quality, on time, and within budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning.
• Monitors study metrics to ensure quality and performance standards are met by vendors and assigned program staff.
• Develops and manages detailed project and other trial-related plans and documentation and provides regular study status updates to senior management.
• Manages vendors' adherence to contractual obligations including proactively recognizing changes in scope and collaborating with senior management to ensure timely completion of contractual documents, including change orders.
• Provides coaching/mentoring to assigned program staff (CRAs, and CTAs) by demonstrating leadership competencies.
• Works collaboratively with Clinical Scientist, Clinical Indication/Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings.
• Proactively identifies potential resource needs to management.
• Participates in the development and review of department SOPs and process improvement initiatives.

Qualifications

• Bachelor's degree in the life sciences, healthcare, or related field.
• Minimum of 7+ years of clinical trial management experience within pharmaceutical / biotechnology industry, managing the logistics of clinical trial execution.
• Minimum 2+ years of indirect/influence management of team members, including coaching and mentoring for knowledge sharing and enhanced communication and leadership skills
• Experience in rare disease and/or orphan indications is preferred.
• Experience managing global, large and/or complex studies and project teams is required. Experience in rare disease and/or orphan indications is preferred.
• Demonstrated experience managing global CROs and other specialty vendors is essential.
• Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations.
• Demonstrated strong leadership skills and the ability to work successfully in matrixed team environment.
• Can work independently with minimal oversight and proactively initiates before asked to assist colleagues and/or manager
• Possess critical thinking skills for problem-solving, conflict resolution, collaboration, and interpretation
• Excellent written and oral communication skills, as well as conflict management, time management and organizational skills.
• Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies.
• Up to 25% travel, domestic and international required.

Education

• None specified