CLINICAL TRIAL MANAGER, CONTRACTOR (OFFICE OR REMOTE)
Company: Arcus Biosciences
Location: Hayward
Posted on: October 22, 2024
Job Description:
Description
The Clinical Trial Manager (CTM) 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
in-house, depending on prior experience. This position will report
to a Clinical Program Director.
Note that this is a 6-month, 40 hour per week contract. May hire at
the SCTM level. Phase III oncology desired. Hourly CTM rate (72-80
per hour), SCTM hourly rate (78-87 per hour) W2 contract.
Responsibilities
- Day-to-day management of assigned operational aspects of low to
medium 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
- Supports the development and review of clinical study plans,
presentations or study-related documents
- Supports in the development and design of CRFs, including
participating in the EDC and IXRS 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
- Manages 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
- 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
- Recommends and implements innovative ideas to increase
efficiency and quality of program management activities
- Contributes to process and departmental and cross-functional
improvement activities Requirements
- Bachelor's degree, preferably in a scientific field
- Minimum 5+ years of related industry experience in the
pharmaceutical industry or equivalent, plus 2+ years of trial
management experience, preferably in oncology
- Demonstrates core understanding of clinical trial related
terminology and activities Skills/Abilities
- Thorough understanding of ICH GCP guidelines and Code of
Federation 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)
- 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.
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.
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Keywords: Arcus Biosciences, West Sacramento , CLINICAL TRIAL MANAGER, CONTRACTOR (OFFICE OR REMOTE), Executive , Hayward, California
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