Clinical Trial Manager/Sr. Clinical Trial Manager (CTM)

Location
Hayward, California
Posted
Jul 27, 2021
Ref
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Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

Job Summary:

The Clinical Trial Manager (CTM) will provide clinical study support to the Clinical Program Manager 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.

Remote-based is optional depending on prior experience. This position is remote or in-house, depending on prior experience.  This position will report to a Clinical Program Director.  Any in-house positions for this role will begin home-based until offices are opened to normal operating procedures. 

Responsibilities:

  • Day-to-day management of assigned operational aspects, 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 accurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reports
  • Manages and tracks patient enrollment for complex clinical trials
  • Ensure studies are managed and executed in accordance with ICH GCP, regulations, the protocol, and company SOPs
  • Supports and may lead 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
  • 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
  • Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Program Manager, as needed
  • 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, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, 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 PM in clinical site oversight, data entry timeliness, assists with resolving site issues
  • Assists with set-up and review of clinical trial TMF
  • Mentoring junior team members
  • Organizes and manages internal team meetings, investigator meetings, and other trial­ specific meetings, as requested
  • 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

 Qualifications:

  • 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 medical terminology and clinical trial activities

Skills/Abilities:

  • Thorough understanding of ICH GCP guidelines
  • 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)
  • Proven problem solving and decision-making skills
  • Excellent IT Microsoft skills and experience using clinical trial management we-based systems (i.e. EDC, IRT, CTMS, eTMF, etc)
  • Ability and willingness to travel 10-20% (domestic and international)

Arcus Biosciences is an equal opportunity employer.