Study Start Up Manager

Direct and manage the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. The role involves overseeing the execution of site activation and/or maintenance for assigned projects, developing and implementing the management plan, and ensuring collaboration across Regulatory & Site Activation. The Study Start Up Manager will provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials.

What You Will Do

The Study Start Up Manager will oversee the execution of site activation and/or maintenance for assigned projects, develop and implement the management plan, and ensure collaboration across Regulatory & Site Activation. The role involves creating and/or reviewing technical and administrative documentation to support business development and enabling study initiation and maintenance. The Study Start Up Manager will also provide overall guidance and oversight of multi-regional and multi-protocol programs during the initial start-up and maintenance phase.

Why It Might Be a Fit

The Study Start Up Manager will be a fit for someone with strong negotiation and communication skills, excellent interpersonal skills, and a proven ability to work through others to deliver results to the appropriate quality and timeline metrics. The role requires a thorough understanding of the regulated clinical trial environment and in-depth knowledge of the drug development process. The Study Start Up Manager will also have the ability to exercise independent judgment, take calculated risks when making decisions, and establish and maintain effective working relationships with co-workers, managers, and sponsors.

Requirements

• Bachelor's Degree in Life sciences or related field
• 7 years' relevant experience in a scientific or clinical environment
• Strong negotiation and communication skills
• Excellent interpersonal skills and strong team player
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
• Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process
• Demonstrated proficiency in using systems and technology to achieve work objectives
• Good regulatory and/or technical writing skills
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
• Good leadership skills, with ability to motivate, coach and mentor
• Good organizational and planning skills
• Ability to exercise independent judgment taking calculated risks when making decisions
• Good presentation skills
• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors
• Excellent understanding of study financial management
• Proven ability to work on multiple projects balancing competing priorities

Benefits

• Base pay range of $74,600.00 - $216,000.00
• Incentive plans, bonuses, and/or other forms of compensation
• Health and welfare benefits
• Other benefits