Clinical Trial Manager / Sr. Manager

ALX Oncology Inc.•South San Francisco, CA

1d•$140,000 - $170,000•Hybrid

About The Position

Reporting to the Executive Director, Clinical Operations, the Clinical Trial Manager / Sr. Manager will support the clinical team to achieve all milestones and deliverables from protocol creation to study completion. The CTM / Sr. CTM 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 CTM / Sr. CTM will manage cross-functional activities and manage vendors as needed in order to ensure that clinical study goals are met on time and within budget.

Requirements

Bachelor’s degree in an applicable discipline combined with 8+ years of related experience in Clinical Operations, Clinical Development, or Clinical Project Management.
Demonstrated experience independently managing global clinical trials from study start-up through conduct and close-out.
Experience overseeing CROs, clinical sites, and other vendors, including management of timelines, budgets, deliverables, quality, performance, and issue escalation.
Experience supporting site selection and activation, enrollment, study execution, and ongoing site performance.
Experience supporting clinical trial audits and regulatory inspections, including inspection readiness and TMF quality.
Strong working knowledge of ICH/GCP guidelines and applicable global clinical trial regulations.
Good understanding of EDC, IRT, CTMS, eTMF, and other clinical systems.
Strong judgment and problem-solving skills, including the ability to identify, prioritize, and resolve clinical trial issues and risks.
Strong communication, collaboration, and relationship-building skills, with the ability to communicate concepts clearly and influence cross-functional teams and external partners.
Demonstrated ability to work independently, prioritize competing demands, and adapt to evolving programs and business needs in a fast-paced, resource-constrained environment.

Nice To Haves

Candidates at the Sr. CTM level will be expected to have additional years of experience.
Small biotech/biopharma or startup experience highly desired, in addition to experience managing oncology clinical trials; early-phase and solid tumor.
MS, RN, and/or CRC experience a plus.

Responsibilities

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.
Manage clinical operational aspects of a global clinical trial including start-up, conduct and close-out activities including monitoring oversight and routine data cleaning
Contribute to the development and/or review of study plans, ICFs, site manuals, patient materials, CRF completion guidelines, etc.
Proactively identify 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 multicenter trials as well as in investigator-initiated studies.
Oversee CRO activities to ensure compliance with global regulatory requirements.
Interact collaboratively with Biometrics, 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.
Manage all clinical operational aspects of a global clinical trial including start-up, conduct and close out activities.
Support other Clinical Operations and organizational priorities as needed.