Study Start-Up And Site Contracts Manager

Overview

• Manage study start-up processes and site contract negotiations for clinical trials in oncology.
• Collaborate with internal teams and external stakeholders to ensure timely site activation.
• Analyze and resolve challenges in regulatory compliance and contract execution.
• Develop workflows and standardize procedures to optimize study start-up efficiency.
• Ensure adherence to regulatory guidelines and clinical trial methodologies.
• Support IRB/EC submissions and review Informed Consent Forms for compliance.
• Coordinate with vendors to achieve quality execution of start-up activities.
• Provide guidance on protocol interpretation and study documentation to research sites.

Key Responsibilities & Duties

• Negotiate clinical trial agreements with investigative sites ensuring favorable terms.
• Collaborate across Clinical Development, Medical Affairs, and Regulatory Affairs for timely site start-up.
• Evaluate priorities and adjust strategies to meet business needs effectively.
• Identify and mitigate risks in study start-up processes proactively.
• Lead internal study start-up team meetings and develop site initiation plans.
• Ensure quality and compliance of Trial Master File documents during start-up.
• Track and report site interaction status updates accurately and descriptively.
• Support vendor performance oversight to achieve start-up timelines and quality.

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.