Description
The Senior Manager, Inspection Readiness, Business Operations, Clinical Operations will be responsible for developing and implementing a robust, proactive inspection readiness program for the Clinical Operations function that ensures compliance with global regulatory requirements and Good Clinical Practice (GCP). This individual will work cross-functionally on Clinical Operations initiatives that enhance inspection readiness, quality management, training, and continuous improvement across clinical trials.
In addition, this role will support operational excellence initiatives, audit/inspection support, and the overall culture of compliance and quality within the Clinical Operations function. This position may be remote or hybrid for Bay Area candidates, depending on experience, and reports to the Head of Business Operations and Enablement, Clinical Operations.
Responsibilities:
- Develop, implement, and manage comprehensive inspection readiness strategies and frameworks across clinical trials for the Clinical Operations function. Lead and coordinate cross-functional inspection readiness activities including storyboarding, mock interviews, room logistics, and trial team preparation.
- Serve as primary operational functional contact and SME during sponsor or regulatory inspections, support trial management staff in real-time during inspections.
- Develop, track, and report inspection readiness KPIs, gap assessments, and progress reports to leadership and stakeholders.
- Maintain a state of constant inspection readiness across all trials, leveraging historical audit findings, QMS inputs, and risk-based approaches.
- Develop and deliver targeted GCP and inspection readiness training across clinical operations. Collaborate with the inspection readiness team to update materials and deliver role-specific guidance related to inspections.
- Serve as advisor and SME for investigations, quality events, and CAPA owners within QA/QE/CAPA processes for the operations team. Identify trends and gaps; lead the implementation of preventative measures and quality improvements in Clinical Operations.
- Identify, provide recommendations, develop, and lead operational excellence initiatives within the Clinical Operations Organization, including the creation and delivery of tools, processes, templates, training, and guidance to drive efficiency, compliance, and best practices, while ensuring quality is integrated into all processes.
- Lead development of the Clinical Operations Organization’s standard operating procedures (SOP), work instructions (WI), other clinical quality documents, and partner with subject-matter experts to modify and improve existing quality documents when required.
- Identify, develop, and implement onboarding and training/training-related needs from new processes, process improvements within the Clinical Operations Organization. Deliver training to Clinical Operations Organization.
- Deliver lessons-learned sessions and best practice forums with study execution teams.
- Mentor junior team members on quality mindset, inspection preparedness, and clinical compliance practices.
Qualifications:
- Bachelor’s degree, preferably in a scientific field.
- Minimum 8+ years of related industry experience at a Sponsor or CRO plus 4+ years of trial management experience, preferably in oncology. Filing experience a must.
- Demonstrates core understanding of clinical trial related terminology and clinical trial activities.
- Thorough understanding of ICH GCP guidelines.
- Proficient in developing and writing SOPs.
- Understanding of clinical trial processes and experience in driving execution.
- Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
- Excellent interpersonal communication and negotiation skills.
- Strong communication skills both verbal and written are required (including presentation of materials to internal teams and external partners).
- Self-motivated, assertive, and able to work independently or as part of a team.
- Demonstrates problem solving and decision- making skills.
- Excellent Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.).
- Ability and willingness to travel 10-20% (domestic and international).
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 $165,000 - $200,000 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.
EOE
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. #LI-EW1#LI-Remote
