Clinical Trial Manager

About you:

You will contribute to advancing our understanding of autophagy regulation and its therapeutic potential in neurodegenerative diseases. You work well independently but will also thrive in a cross-functional role working with multiple therapeutic programs. You are excited to work on, and solve, hard problems and ultimately help extend healthy human lifespan!

In this role you will:

• Support and collaborate with cross-functional teams to plan, initiate, and oversee clinical trials, ensuring alignment with company timelines and objectives.
• Identify, engage, and manage the activities of clinical CROs, central lab, imaging, and specialty labs to execute clinical trials.
• Support site specific development of IRB submission packages or central IRB submissions.
• Obtain and review all required essential documents necessary for study/site initiation.
• Contribute to development and review of clinical trial documents such as clinical protocol, informed consent form(s), patient facing materials, etc.
• Monitor CRO and site performance, including recruitment, data collection, and compliance.
• Ensure trial logistics, such as drug supply and data collection, are managed efficiently.
• Provide support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable.
• Monitor trial data quality, integrity, and completeness. Prepare and deliver trial progress updates to senior management and stakeholders.
• Ensure all trial activities comply with regulatory standards and guidelines (e.g., GCP, FDA, EMA, TGA).

You might thrive in this role if you have:

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field with 5+ years of clinical trial management experience in a Pharmaceutical/Biotech organization.
• Experience in managing CROs, clinical sites, and cross-functional study teams.
• Proven, excellent project management, organizational, and communication skills.
• Strong knowledge of ICH-GCP guidelines, and regulatory requirements, clinical trial phases, especially early Phases.
• Experience with clinical trials for small molecule products in an industry environment.
• Flexibility to work adjusted schedules to accommodate international time zones, ensuring effective management of vendors and partners.
• Strong leadership and problem-solving skills, proactively identifying risks and implementing solutions.
• Experience managing multiple priorities and diverse teams and stakeholders to meet deadlines in a fast-paced environment.
• Strong attention to detail with a focus on data integrity and quality assurance.

It’s a bonus if you have:

• Experience coordinating international trials.
• Experience in neurodegenerative diseases or Alzheimer’s Disease clinical trials.

$140,000 – $175,000 a year
Total compensation also includes generous equity and benefits including:

– Medical, dental, and vision insurance for you and your family
– 401(k) plan with 4% matching
– Flexible time off and 10 company holidays per year
– Annual learning & development stipend
– Daily Retro-sponsored lunch and snacks