Senior Clinical Program Manager
$175K - $190K/yr
... eTMF, etc.). * Ability and willingness to travel 10-20% domestically and internationally. This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The ...
$175K - $190K/yr
... eTMF, etc.). * Ability and willingness to travel 10-20% domestically and internationally. This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The ...
$175K - $190K/yr
... eTMF, etc.). * Ability and willingness to travel 10-20% domestically and internationally. This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The ...
A Remote eTMF (electronic Trial Master File) job involves managing and maintaining digital clinical trial documentation from a remote location. Professionals in this role ensure regulatory compliance, organize essential trial records, and facilitate audits. They work with sponsors, CROs, and regulatory bodies to ensure proper documentation throughout a clinical study. Strong knowledge of GCP (Good Clinical Practice) guidelines and document management systems is typically required. This role is essential in supporting the smooth execution of clinical trials while ensuring regulatory requirements are met.
As a Remote eTMF Specialist, your daily responsibilities typically include uploading, reviewing, and maintaining essential clinical trial documents within electronic Trial Master File systems to ensure proper organization and compliance. You will regularly collaborate with clinical project teams, regulatory personnel, and external partners to track document statuses and resolve any discrepancies. Ensuring all documentation meets internal quality standards and regulatory requirements is a key focus. This role also often involves preparing the eTMF for audit and inspection readiness, which requires strong attention to detail and proactive communication.
To thrive as a Remote eTMF (electronic Trial Master File) Specialist, you need strong knowledge of clinical trial documentation, GCP (Good Clinical Practice) compliance, and previous experience working in clinical research or regulatory affairs. Proficiency with eTMF systems such as Veeva Vault, Medidata, or MasterControl, along with familiarity with regulatory guidelines, is typically required. Excellent attention to detail, organizational skills, and effective remote communication abilities set top candidates apart. These skills ensure that clinical trial documentation is accurate, audit-ready, and compliant with regulations in a virtual work environment.
$175K - $190K/yr
Full-time
Posted 6 days ago
Summary
The Senior Clinical Program Manager (Sr. CPM) is responsible for the strategic and operational leadership of one or more complex clinical studies. This role ensures clinical trials are executed on time, within budget, and in compliance with ICH GCP, regulatory requirements, and Arcus SOPs. The Sr. CPM performs all core responsibilities of the Clinical Program Manager (CPM), with expanded scope in strategic study oversight, vendor management, leadership, and program-level contribution. The Sr. CPM may mentor junior staff and serve as a subject matter expert within Clinical Operations.
This position is open to remote candidates within the U.S.; candidates located in the Bay Area are expected to work in a hybrid model with regular in-office presence.
Responsibilities
Strategic & Operational Study Leadership
Cross-Functional & Study Team Leadership
Vendor and CRO Oversight
Documentation, Quality, & Compliance
Study Tracking, Budget, & Reporting
Process Improvement & Leadership Contributions
Qualifications
This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $175,000 $190,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
Physical Requirements Office Setting
Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
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Biotechnology research and development
51 - 200 Employees
Hayward, CA, US
2015