Company Description
Founded in 2025, Amandala Neuro is a rapidly-growing biotech startup spun out ahead of the strategic combination of Beckley Psytech and Atai Life Sciences (now AtaiBeckley) to enable focused development of ELE-101 (an IV dosage form of psilocin, the active metabolite of psilocybin), with a pipeline of follow-up candidates to address poorly-controlled neuropsychiatric conditions.
We are dedicated to helping patients suffering from neurological and psychiatric disorders by developing a pipeline of short-acting psychedelic compounds. Our vision is for clinically validated psychedelic medicines to be integrated into medical practice in order to help patients in need around the world suffering with these profoundly debilitating conditions.
Role Description
We are seeking a detail-oriented Clinical Trial Associate with a minimum of one year of clinical research experience to support sponsor oversight of Phase 1 and 2 programs. This role will play a critical part in maintaining Trial Master File quality, ensuring documentation integrity, and coordinating communications across CROs and internal stakeholders in a growing, biotech environment. The role reports to the Director of Clinical Operations.
Key Responsibilities
* Support sponsor oversight of Phase 1 and 2 clinical trials conducted through CRO partners
* Oversight of CRO managed eTMFs, to ensure maintenance, contemporaneous and complete Trial Master File (eTMF)
* Perform reviews of the TMF for quality, accuracy, and regulatory compliance
* Coordinate document flow between CROs, sites, vendors, and internal teams
* Maintain tracking logs (regulatory, safety, enrollment, milestones)
* Support preparation for regulatory inspections and audits
* Assist in study start-up activities, including essential document collection
* Document meeting minutes and maintain action item trackers
* Support controlled document management and version control processes
Qualifications
* Experience with managing and maintaining Informed Consent and Trial Master File (TMF) documentation
* Knowledge of clinical trial processes, including Clinical Trials and Clinical Operations
* Research skills, including the ability to analyze, interpret, and summarize data
* Strong attention to detail and organizational skills
* Ability to collaborate effectively in a remote team environment
* Familiarity with regulatory requirements and Good Clinical Practice (GCP) guidelines including ICH-GCP R3
* Bachelor’s degree in life sciences, healthcare, or a related field
* Minimum 1 year experience in a clinical research role
Requirements added by the job poster
* Bachelor's Degree