Clinical Trial Manager

Location
Berkeley, CA, US
Posted
Dec 06, 2018
Ref
18-096R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Overview

Manage all aspects of one or more oncology Phase 1 - 4 clinical trials, from protocol development to final report, including trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.

Responsibilities

  • Lead clinical trial project execution for oncology programs to ensure that trial timelines, costs, and quality metrics are met.
  • Develop, manage, and oversee clinical trial timelines for the conduct of the clinical trial protocol.
  • Lead role as primary contact for cross-functional area representatives in managing protocol execution.
  • Manage risk including prioritization of competing tasks and issues to ensure program objectives are successfully accomplished in a timely manner.
  • Manage the oversight of critically assessing data integrity to find trends/outliers and timely correct identified issues.
  • Coordinate and oversee, with Clinical Contracts/Budget management, the financial aspect of of clinical trials to ensure accuracy and timeliness of service provider and site payments.
  • Forecast and oversee all clinical supplies, study drug, lab supplies and other required materials.
  • Manage study milestones to ensure accurate tracking and reporting of study matters.
  • Oversee ongoing service provider management (e.g., CROs, IVRS, central labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
  • Collaborate with Clinical Contracts/Budget to manage efforts for clinical service provider selection.
  • Manage, guide and mentor to CRAs and CTAs.
  • Collaborate with Clinical Quality Assurance to maintain quality standards in compliance with regulatory requirements/guidance and in adherence to SOPs, ICH/GCP, and local regulations.
  • Lead and/or participate in ongoing process improvement initiatives.
  • Supports the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.
  • Perform other duties as assigned or required.


Qualifications

  • Minimum of 3 years' staff management experience.
  • Bachelor's degree with at least 5+ years of oncology CRA experience for the manager level..
  • Broad and current knowledge of regulations, clinical development process, and oncology.
  • Proven leadership skills to direct protocol execution to ensure timeline, budget, and quality metrics are met.
  • Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate.
  • Experience developing trial plans, including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
  • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
  • Excellent organizational and negotiation skills. Proven ability in creative problem-solving; possess sound judgment.
  • Team oriented - collaborate effectively with the Clinical Operations study team, cross-functional team members, and external partners.
  • Proficient computer skills, specifically with Microsoft Office Suite that includes Word, Excel, PowerPoint, and Outlook.
  • Working knowledge of MS Project for development and update of clinical study timelines.
  • The incumbent in this position must be able to remain in stationary position 50% operating a computer and other office equipment, and will need to occasionally move about the office for meetings and to access files and other office equipment.
  • Willing to travel up to 25%.


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