Clinical Trial Manager

ALX Oncology Inc.•South San Francisco, CA

3d•$120,000 - $140,000•Hybrid

About The Position

Reporting to the Director, Clinical Operations, the Clinical Trial Manager will support the clinical team to achieve all milestones and deliverables from protocol creation to study completion. The 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 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 of Science (BS) degree preferred.
Five to eight (5-8) years experience with broad and deep knowledge of Clinical Operations, Clinical Development, and Clinical Project Management
Experience with CRO and Vendor Management.
Experience with Clinical Trial Audit activities.
Working knowledge of ICH/GCP guidelines.
Effective written and verbal communication skills.
Critically evaluates job tasks and the impact on overall trial management objectives.
Sound problem-solving capabilities.
Good judgment in triaging issues from internal and external customers.
Ability to work independently when needed
Effectively collaborates with Clinical Trial Team members.
Outstanding organizational skills with the ability to be flexible and adapt to a changing environment.
Exceptional attention to detail.

Nice To Haves

Small biotech/biopharma, startup experience highly desired
Good understanding of EDC, IRT, CTMS eTMF and other clinical systems
MS/RN, CRC experience a plus
Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home).

Responsibilities

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.
Other duties as assigned.