Senior Clinical Trial Manager

Sr. Clinical Trial Manager (C TM)

The Sr. Clinical Trial Manager (C TM) will provide clinical study support to the Clinical Program Manager/Study Management Team Lead (SMTL) for one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. Key accountabilities include assuring successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as supporting clinical project timelines, contracts, budgets, vendor management, invoicing, accruals, oversight monitoring visits, meeting milestones and deliverables, and internal/external communications. This position is remote or hybrid and will report to the Associate Director, Clinical Operations.

Responsibilities

Day-to-day management of assigned operational aspects of complex clinical trials, including but not limited to vendor/laboratory management, oversight of clinical sites, etc.

Obtains and reviews all required essential documents necessary for study/site initiation

Maintains/files accurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reports

Manages and tracks patient enrollment, site performance and monitoring metrics

Performs tasks in accordance with ICH GCP, regulations, the protocol, and company SOPs/Policies

Leads the development and review of clinical study plans, presentations or study-related documents

Support in the development and design of CRFs, including participating in the EDC and I X RS specification process and UAT on related systems

Assists with set-up of central labs and study vendors as required, including liaising with Clinical Program Manager and CRO to ensure site training and timely initiation of clinical study sites

Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Program Manager, as needed

Works closely with data management lead to perform data cleaning activities with cross-functional team

May lead and coordinate protocol deviation review and documentation

Manage clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics

May perform accompanied site visits with CRO Site Monitors to ensure correct study procedures according to SOPs and protocol procedures, review of routine regulatory documents/files in compliance with protocol, regulatory requirements, site and CRO SOPs, and study plans, as required

Reviews monitoring trip reports and track resolution of all action items

Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal)

Assists with providing oversight of CROs and vendors

Coordinates with CRO and SMTL in clinical site oversight, data entry timeliness, assists with resolving site issues

Assists with set-up and review of clinical TMF

Mentoring junior team members

Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings, as requested

Contributes to development and review of clinical trial documents such as clinical protocol, informed consent form(s), patient facing materials, etc.

Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable

Recommend and implement innovative ideas to increase efficiency and quality of program management activities

Contributes to process and departmental and cross-functional improvement activities

Qualifications

Bachelor’s degree, preferably in a scientific field

6+ years of related industry experience in the pharmaceutical industry or equivalent, plus 3+ years of trial management experience, preferably in oncology

Demonstrates core understanding of clinical trial related terminology and activities

Thorough understanding of ICH GCP guidelines and Code of Federal Regulations

Understanding of clinical trial processes from study start-up through study closure

Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors

Excellent planning and organization skills

Self-motivated, assertive, and able to function independently and as part of a team

Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)

Demonstrates problem solving and decision-making skills

Excellent IT 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 $160,000 - $170,000 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. 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 identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets