non title

non title Livingston, Scotland

Novasyte
Full Time Livingston, Scotland 10.56 - 12.04 GBP Today
Job description

Job Overview
Manage the process of designing and launching clinical research studies; manage activities of the Sponsor/Clinical Research Organization (CRO); lead colleagues in the design and organization of project components during Start-Up; develop and maintain best practices within the organization; Accountability and ownership for the quality of all start-up work and sponsor deliverables.
Essential Functions
  • Develop the database design requirements which include configuration definition for full protocols, protocol amendments and sponsor study changes
  • developing and maintaining client design standards as applicable in accordance with the Clinical Protocol
  • Manage study database configuration. Support internal/external stakeholders in the development of sponsor standards and as a Set-up point of contact
  • Collaborate with colleagues during planning meetings regarding project timelines, and project-related issues focusing on capabilities within, but not limited to, Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management
  • Responsible for updates to the project, including the action/issues logs, status sheets and timelines during the startup phase, where applicable
  • Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved
  • Proactively manage changes in study related project scope, identify potential risks, and devise contingency plans
  • As required, prepare and present study-specific materials and services at Investigator, Kick-off meetings. Participate in external and internal audits as required
  • Provide day to day guidance to more junior staff assigned to project or within a specific program area
  • may act as a mentor as well as assist in the training and development of more junior staff
  • Participate in improvement projects as defined by the relevant process improvement management team. Conduct project lesson learn sessions and create a recommendations report in order to identify successful and unsuccessful project elements, when applicable
  • Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
Qualifications
  • Bachelor's Degree Science or related field Pref
  • Other Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
  • Minimum 2 years of clinical or research industry experience, including 1 year project management / project set up experience Pref Or
  • Equivalent combination of education, training and experience Req
  • Possess strong interpersonal skills.
  • Demonstrated ability to meet deadlines.
  • Some experience in leading Phase I-IV clinical trials would be advantageous. Some technical and therapeutic expertise would be advantageous, in addition to significant experience with key customers.
  • Demonstrated computer proficiency with Microsoft Office. Working knowledge of Clinical Trials Management Systems would be an advantage.
  • Possess an understanding of medical and clinical research terminology.
  • Demonstrated ability to work in a fast-paced environment.
  • Knowledge of Project Management processes and terminology.
  • Excellent organizational and time management skills.
  • Excellent accuracy and attention to detail skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.
https://q2labsolutions.com/careers

non title
Novasyte

www.novasyte.com
Carlsbad, United States
Tim Gleeson
$25 to $50 million (USD)
501 to 1000 Employees
Company - Public
Health Care Products Manufacturing
2008
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