About this role

  • Posted on

  • Location

    Pennsylvania

  • Salary

    $500 - $750 per day

  • Type

    Contract

  • Division

    Clinical Operations Jobs

  • Reference

    BBBH16733_1613986752

  • Start date

    ASAP

  • Managing this role

Executive Consultant

Jon Martin

+44 203 8540 262

jon.martin@xplorelifescience.com

154-158 Shoreditch High Street, E1 6HU

Description

I’m working with a fast growing ophthalmology / gene therapy focused biotech who are seeking multiple Clinical Project Managers across the UK and US to join a dynamic team responsible for the oversight planning and execution of assigned clinical studies to support product development.
This role will be responsible for all assigned studies – clinical operational oversight as well as the execution of monitoring of study deliverables, performing protocol-related site management activities, participating in study planning and set-up activities including vendor management, project management, coordination of study and implementation plans?and supporting third party vendor relationships.

  • Overseeing new clinical studies within their developing pipeline
  • Working with fellow operational team members to ensure consistent operational execution over study program
  • To be an active member of the operational team and help drive the department’s evolution and success
  • To adopt a ‘site-centric’ role creating relationships with assigned key sites, Investigators and site personnel

Role Responsibilities:

  • Responsible for the oversight and day-to-day management of clinical operations activities
  • Ensure that the planning, implementation, coordination and reporting of the clinical studies in line with the corporate objectives
  • Act as a key study contact for studies and effectively plan and communicate study milestones, deliverables, timelines and quality standards to other functions and other stakeholder groups
  • Support and mentor team of Associate Clinical Project Managers/Clinical Trial Associates assigned to studies
  • Support and monitor CRO and third-party vendor activities, including IMP management, Investigator contract/budgets, TMF management, study set-up, project management, biostatistics and medical writing
  • Monitor progress of studies, identify study-related trends/issues and work with the Senior Clinical Operations team to implement corrective actions when necessary
  • Attend site visits (including, but not limited to, Site Initiation Visits and study surgeries) where local and national travel policies allow
  • Work with the study team to develop recruitment strategies
  • Through adoption of a site centric model, liaise directly with assigned sites to ensure maintenance of site relationships, troubleshoot study related issues and impart key messaging to the site
  • Prepare and/or review Study Plans, Vendor Specifications and Scopes of Work
  • Contribute to the preparation, design and/or review of essential regulatory study documents, ethics and other required local/national submission requirements
  • Drive the identification and selection of clinical trial investigators as per clinical operations strategy
  • In conjunction with Surgical Technical Expert Liaison, oversee execution of the Surgical Training Plan
  • Adopt a Risk Management approach to oversight and execution of assigned clinical studies
  • Coordinate with CMC for the shipment of IP and ancillary supplies to investigator sites
  • Coordinate and/or lead contract and budget negotiations with sites and third-party vendors
  • Lead study operational and/or scientific feasibility, and site set-up activities as per clinical operations strategy
  • Prepare study training materials and present at Internal Workshops and Investigator Meetings
  • Set up and chair study meetings when required
  • Ensure study certifications, insurance, licenses and registrations are maintained

Cross Functional Interactions:

  • Collaboration between the Clinical Project Manager and all functions is anticipated
  • Close relationship to be built with other stakeholders at regular functional meetings and ability to clearly and concisely present updates and issues to the cross functional team

Skills and Experience:

  • Minimum 3 years’ experience working as a Clinical Project Manager in Phase I-IV studies within the pharmaceutical industry or a CRO
  • Extensive experience in direct management of study start up activities
  • Independent thinker with ability to anticipate issues and risks and to mitigate accordingly
  • Team player who is able to prioritise workload in a fast-paced environment

Desired skills

  • ATMP/GMO/Biologics handling Ophthalmology experience
  • Working within a small to mid-sized Biotech
  • Gene Therapy / Oncology / Biologics therapeutic experience

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