Clinical Trial Manager, Clinical Operations

ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.  

The Clinical Trial Manager will support the clinical team to achieve all milestones and deliverables from protocol creation to study completion. The candidate will actively participate to help develop and execute the clinical trial strategy in support of the Clinical Development Plan, and to work across departments to ensure that studies are planned and conducted efficiently and with the highest quality. The candidate will manage cross-functional activities in order to ensure that clinical study goals are met on time and within budget.

Responsibilities:

These may include but are not limited to:

• Contribute to strategic direction for outsourcing, selection, and oversight of CROs
• Continuously monitor study timelines, study progress, data quality, study costs, ensuring corporate milestones and deliverables are met;
• Contribute to the development and/or review of study plans, ICFs, site manuals, patient materials, CRF completion guidelines, etc.
• Support Finance and Corporate Development to forecast estimated costs for potential studies. Work closely with  Clinical and Finance teams to review CRO budgets, change orders, invoices, and to approve payments.
• Proactively identifies potential study issues/risks and recommend/implement solutions
• Work with internal team members and CROs in the identification, evaluation and selection of clinical trial investigators and sites, including cooperative groups in multi-center trials as well as in investigator initiated studies.
• Oversee CRO activities to ensure compliance with global regulatory requirements. 
• Interact collaboratively with Quality, Regulatory, CMC, Finance, and Clinical teams to ensure operational excellence in clinical trial execution to ensure compliance with GCP and ICH guidelines and financial reporting requirements.
• Perform TMF reviews ensuring quality
• Support development of SOPs and establishment of associated training for teams, and ensure consistency, quality and compliance with global clinical standards.

• Manages all clinical operational aspects of a global clinical trial including start-up, conduct and close out activities

Requirements:

• BS (Science degree) with 4 years, MS/RN with 2 years

• Broad and deep knowledge of clinical operations, clinical development, and clinical project management
• Experience with CRO management
• Experience with clinical trial audit activities
• Expected competencies:
  • Working knowledge of ICH/GCP guidelines
  • Effective written/verbal communication
  • Ability to work independently as well as collaboratively in a multidisciplinary setting
  • Flexibility and willingness to adapt in a changing environment
  • Ability to travel
• Travel may be required up to 25% of your time
• The successful candidate will be required to reside within a commutable distance of our South San Francisco office. ALX Oncology Inc. follows a hybrid work model (i.e., part-time in South San Francisco office with flexibility to work part-time remotely).

Salary: $140,000-$160,000 DOE

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

Salary : $140,000 - $160,000