Sr. Clinical Trial Manager

About the role

As a Senior Clinical Trial Manager at Structuretx, you will play a pivotal role in overseeing and managing clinical trials from initiation to completion. This position is integral to our mission of advancing innovative therapies in the biotechnology sector. You will collaborate closely with cross-functional teams, ensuring that all trial activities are executed in compliance with regulatory standards and within budget. Your expertise will help drive the success of our clinical programs, ultimately contributing to the development of groundbreaking treatments.

Key facts

What you'll do

• Lead the planning, execution, and management of multiple clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
• Develop and implement clinical trial protocols, informed consent documents, and other essential study materials in collaboration with clinical teams.
• Coordinate with external vendors, including Contract Research Organizations (CROs), to ensure effective trial execution and data integrity.
• Monitor trial progress and performance metrics, providing regular updates to stakeholders and making adjustments as necessary to meet project goals.
• Ensure compliance with Good Clinical Practice (GCP), local regulations, and company policies throughout the trial lifecycle.
• Oversee the selection and management of clinical trial sites, including site initiation, training, and ongoing support.
• Collaborate with data management and biostatistics teams to ensure accurate and timely data collection and analysis.
• Manage trial budgets and resource allocation, identifying potential risks and implementing mitigation strategies.
• Facilitate communication between internal teams and external partners to ensure alignment and transparency throughout the trial process.
• Prepare and present trial progress reports to senior management and other stakeholders, highlighting key findings and challenges.
• Train and mentor junior clinical staff, fostering a culture of continuous learning and professional development within the team.
• Stay abreast of industry trends and advancements in clinical research methodologies, incorporating best practices into trial management processes.

Requirements

• Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
• A minimum of 5 years of experience in clinical trial management, with a strong understanding of GCP and regulatory requirements.
• Proven track record of managing multiple clinical trials simultaneously, demonstrating strong organizational and project management skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across diverse teams.
• Strong analytical skills, with experience in data interpretation and reporting.
• Proficiency in clinical trial management systems and electronic data capture tools.
• Ability to work independently and make decisions in a fast-paced environment.
• Detail-oriented with a commitment to maintaining high-quality standards in all aspects of trial management.

Nice to have

• Experience in oncology or rare disease clinical trials is a plus.
• Familiarity with regulatory submissions and interactions with health authorities.
• Certification in clinical research (e.g., ACRP or SOCRA) is advantageous.
• Knowledge of budget management and financial oversight in clinical trials.

Skills & tools

• Strong project management skills, with proficiency in tools such as Microsoft Project or similar software.
• Familiarity with electronic data capture (EDC) systems and clinical trial management software (CTMS).
• Excellent written and verbal communication skills, capable of producing high-quality documentation and reports.
• Ability to analyze complex data sets and present findings clearly to various stakeholders.

Practical notes

• This position is based in South San Francisco, California, and may require occasional travel to clinical sites or conferences.
• Candidates should be prepared for a fast-paced work environment and be adaptable to changing project needs.
• Structuretx offers a competitive salary and benefits package, including health insurance, retirement plans, and opportunities for professional growth.

If you are a driven and experienced clinical trial professional looking to make a significant impact in the biotechnology field, we encourage you to apply for the Senior Clinical Trial Manager position at Structuretx. Join us in our mission to develop innovative therapies that improve patient outcomes and transform lives.