What are the responsibilities and job description for the Clinical Trial Manager position at Retro?
Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan.
We’re building a mission-driven team of accomplished and kind individuals who embrace our startup culture of rapid iteration, transparency, and versatility.
We are seeking a new member to join our team to support clinical development and execute studies aimed at evaluating autophagy-targeting interventions. You will report directly to the Head of Early Drug Development and play a key role in driving the success of our clinical initiatives. You will maintain a sense of urgency and drive the pace of Retro’s clinical program to help people gain access to innovative treatments and extended healthy lifespan.
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!
\n- 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).
- 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.
- Experience coordinating international trials.
- Experience in neurodegenerative diseases or Alzheimer's Disease clinical trials.
We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert. We are an equal opportunity employer; we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are diverse in background and singular in mission.
Salary : $140,000 - $175,000
