Study Start-Up And Site Contracts Manager

Overview

• Drive the study start-up process for oncology clinical trials, ensuring timely site activation and compliance with regulatory standards.
• Collaborate with cross-functional teams to streamline workflows and optimize trial initiation strategies.
• Lead site contract negotiations, fostering productive relationships with investigative sites.
• Develop and implement procedures to enhance efficiency and adherence to clinical methodologies.
• Provide expert guidance on protocol interpretation and regulatory compliance to research sites.
• Support IRB/EC submissions and ensure informed consent forms meet compliance standards.
• Coordinate with vendors to ensure quality execution of study start-up activities.
• Analyze and resolve challenges in contract execution and regulatory adherence proactively.

Key Responsibilities & Duties

• Negotiate clinical trial agreements with investigative sites, ensuring favorable terms and timely execution.
• Collaborate with Clinical Development, Medical Affairs, and Regulatory Affairs teams to achieve site activation goals.
• Identify and mitigate risks in study start-up processes, ensuring smooth project progression.
• Lead internal team meetings and develop comprehensive site initiation plans.
• Ensure quality and compliance of Trial Master File documents during the start-up phase.
• Track and report site interaction status updates, maintaining accurate and descriptive records.
• Oversee vendor performance to align with start-up timelines and quality standards.
• Evaluate priorities and adjust strategies to meet dynamic business needs effectively.

Job Requirements

• Bachelor’s Degree in Science or equivalent; legal background preferred.
• Minimum 5 years of experience in study start-up and site contracts management.
• Proven knowledge of clinical trial methodologies and regulatory guidelines.
• Strong analytical skills for resolving study start-up challenges effectively.
• Experience negotiating clinical trial agreements with research sites preferred.
• Ability to manage multiple projects and meet study start-up milestones.
• Excellent communication skills for interacting with diverse stakeholders.
• Ability to work effectively in a matrixed environment and collaborate across teams.