Clinical Trial Manager

POSITION SUMMARY:

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.

PRIMARY RESPONSIBILITIES AND DUTIES:

• 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.

QUALIFICATIONS AND SKILLS:

• 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.
• 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).

SALARY RANGE: $120,000 - $140,000 DOE

PHYSICAL DEMANDS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.

• Ability to communicate in written and oral forms.
• Must be able to interact and communicate in written and oral forms with a diverse group of individuals on both technical and business topics.
• The ability to sit, stand, kneel, stoop, walk, use hands to finger, handle, or feel, point, and reach with hands and arms.
• Must be able to travel 25% of the time without restriction, domestically and/or internationally.
• Must be able to use the telephone and communicate clearly with a host of external individuals, domestically and globally.
• Ability to work at a computer for extensive periods of time.
• Ability to work in a fast-paced working environment managing multiple tasks.

WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS:

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.


ALX Oncology is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

ABOUT ALX ONCOLOGY

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain.


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