Country Trials Manager

Country Trials Manager

TFS HealthScience

Sweden

Description

The Country Trials Manager is responsible for study startup deliverables for assigned studies at a country level that are of moderate to high complexity. For studies where there is more than one country trial manager assigned, may act as the Lead Country Trials Manager for the country or cluster of countries and coordinate all the country activities.

The Country Trials Manager partners with the Study Start Up Project Manager, Study Manager, Site Intelligence Lead, Site Relationship Partner, Site Activation Partner, Contracts Lead, Regulatory Affairs, CRO representatives) and others as required. The Country Trials Manager provides leadership and country strategic planning and organization skills to ensure the delivery of operational Start up aspects of one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.

Accountable for the execution of:

  • Country level implementation of Startup and Site Activation Plans;
  • Country level Recruitment Strategy;
  • Timely and quality EC/RA Submissions;
  • Communication with internal stakeholders as listed above to ensure efficient and timely study startup delivery at a country level.

Requirements

Education

  • A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc; a nursing diploma or associate degree in nursing may also be considered with extensive clinical trial experience;
  • Extensive operational clinical trial experience;
  • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility;
  • English and region/country local language is required.

Experience

  • + 7 years of clinical research experience and/or study management/startup project manager experience;
  • Demonstrated knowledge of site selection, site activation, site readiness interdependencies;
  • Demonstrated knowledge of clinical trial methodology and the drug development process;
  • Demonstrated experience leading cross functional teams;
  • Demonstrated experience in Project Management and Quality Management;
  • Demonstrated experience in a matrix management environment.

Skills and Technical Competencies

  • Expertise in the use of Site Activation tools;
  • Detail oriented & possesses technical expertise;
  • Ability to manage complex processes;
  • Ability to manage in a matrix environment;
  • Risk Identification & Mitigation;
  • Strategic Planning, Analytical and Problem-Solving Skills;
  • Critical Path Analysis;
  • Excellent communication skills, both written and verbal;
  • Ability to adapt to changing technologies and processes;
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization .

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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