CTM EU

KPS Life is looking to hire a Clinical Trial Manager to join one of our Sponsor-dedicated teams. This is a one year contract and can be remotely located anywhere in Europe.

Position Summary

Responsible for the management and oversight of phase I-IV clinical trials, from start up through CSR including, but not limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, monitoring oversight of site-level activities related to ongoing and planned trials, management of third-party vendors for clinical services, management of project timelines and deliverables. Key trial management support to the Associate Directors (CST Leads), as assigned.

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 and 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.
• Manages global monitoring oversight of site-level activities related to ongoing and planned trials
• Develops and manages detailed projects 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.

Position Requirements

• Bachelor's degree in life sciences, healthcare, or related field.
• Minimum of 5+ years of clinical trial management experience within pharmaceutical / biotechnology industry, managing the logistics of clinical trial execution.
• Experience in rare disease and/or orphan indications is preferred.
• Experience managing large and/or complex studies and project teams is preferred. Experience in rare disease and/or orphan indications is preferred.
• Demonstrated experience managing 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 limited oversight and proactively initiate 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.

Travel

• Up to 25% travel, domestic and international required.

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