Description

The Sr. Clinical Trial Manager (CTM) Contractor 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 will report to a Clinical Program Director.

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
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
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
Recommends and implements 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
Minimum 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

Skills/Abilities

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)

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. Lab setting: PHYSICAL REQUIREMENTS*: • Frequently stand, walk, twist, bend, stoop, squat, grasp lightly, use fine manipulation, grasp forcefully, perform desk-based computer tasks, use telephone, write by hand, lift, carry, push and pull objects weighing over 40 pounds. • Occasionally sit, kneel, crawl, reach and work above shoulders, sort and file paperwork or parts. • Rarely climb, scrub, sweep, mop, chop and mix or operate hand and foot controls. • Must have correctible vision to perform duties of the job. • Ability to bend, squat, kneel, stand, reach above shoulder level, and move on hard surfaces for up to eight hours. • Ability to lift heavy objects, possibly weighing up to 50 pounds. • Position may require repetitive motion.

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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Arcus Biosciences

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