The Sr. Clinical Trial Associate (Sr. CTA) supports clinical trial execution from study start-up through close-out, with increasing ownership of activities including Trial Master File (TMF) management, site activation, study tracking, vendor coordination, and study documentation. Working closely with internal and external study partners, the Sr. CTA helps ensure trials are conducted in compliance with ICH-GCP requirements, applicable regulations, and internal SOPs while supporting study quality and inspection readiness.
Preference will be given to candidates who can regularly work onsite Mondays and Tuesdays as part of the company's hybrid work model.
Key Responsibilities include:
- Support Clinical Trial Managers, Study Leads, and Study Management Teams with study start-up, execution, maintenance, and closeout activities.
- Maintain electronic Trial Master Files (eTMF), partnering with CROs and internal teams to ensure essential study documents are complete, accurate, timely, and compliant with applicable requirements.
- Perform ongoing TMF quality reviews, identify and resolve documentation gaps, and support reconciliation activities, audits, health checks, and inspection readiness.
- Support site activation and onboarding activities, including ethics/regulatory submissions and tracking of informed consent forms and other essential site documentation.
- Support oversight of CROs and other study vendors, including tracking deliverables, timelines, documentation, system access and assisting with review of vendor and study plans; proactively identify and address routine issues and escalate risks as appropriate.
- Coordinate and track study-related materials, supplies, and investigational product shipments, as applicable.
- Maintain CTMS, study trackers, and other study-level tools, including enrollment, site monitoring, and data query tracking; compile study and quality metrics and communicate risks to timelines or deliverables.
- Serve as a point of contact for clinical sites, vendors, and internal stakeholders and collaborate cross-functionally with Clinical Operations, Data Management, Regulatory, Safety, and other functions.
- Coordinate study team and investigator meetings, including meeting minutes, action-item tracking, and follow-up.
- Support tracking of vendor and investigator site budgets, contracts, invoices, and payments, as needed.
- Contribute to a culture that reflects ALX's values by acting with integrity, accountability, transparency, and respect. Build strong, collaborative relationships through active engagement with colleagues, including regular onsite participation consistent with the company's hybrid work model.
- Perform other responsibilities as assigned.
Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the list preferred qualifications.
Preferred Qualifications include:
- Bachelor’s degree in a scientific, healthcare, or related field and approximately three years of clinical research experience in a biotechnology, pharmaceutical, or CRO environment. Preference given to candidates with oncology experience.
- Working knowledge of ICH-GCP requirements, the drug development process, the clinical trial lifecycle including study start-up, maintenance, and closeout; experience supporting multiple clinical trials.
- Experience with eTMF and/or EDC systems, such as Veeva Vault; familiarity with CTMS and document reconciliation processes. Proficiency with Microsoft Office applications.
- Excellent organizational skills and attention to detail, with the ability to maintain accurate and timely study documentation and manage multiple responsibilities.
- Effective written and verbal communication and interpersonal skills, with the ability to collaborate effectively with internal teams, clinical sites, CROs, vendors, and other external partners.
- Ability to prioritize work, adapt to changing needs, and independently address routine issues and exercise good judgment in determining when to seek input or escalate concerns.
- Ability to work effectively in a fast-paced, evolving environment, manage competing priorities, and adapt as study and business needs change.
Compensation
The salary range for this position at our South San Francisco, CA corporate office is $115,000 – 125,000. Additional factors such as academic credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, ALX Oncology offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information can be found here: https://alxoncology.com/careers/
About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.
Information for Recruitment Agencies
Please note that ALX Oncology does not accept unsolicited resumes or candidate information from recruitment agencies, including blinded or anonymized resumes, and will not be responsible for any fees associated with unsolicited submissions. Do not contact hiring managers or other ALX Oncology employees directly. Recruiting activities are managed through our Human Resources team.