Gsk

Gsk

Clinical Trial Manager/Local Delivery Lead

Home Worker - USA

Sponsorship not specified$116k-$193kDetected 8 days ago
GCPComplianceProject ManagementStakeholder ManagementNegotiationLogisticsProcurementHRClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationProblem SolvingTime ManagementGxPRegulatory Affairs

About the role

  • Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives.
  • We're uniting science, technology, and talent to get ahead of disease together.
  • Find out more: Our approach to R&D This is a remote home-based role.

Responsibilities

  • Proactively identifies, resolves, and/or escalates risks and issues that may impact study delivery, providing effective troubleshooting and problem‑resolution support to ensure efficient and productive study execution.
  • Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity.
  • This role will provide YOU the opportunity to lead key activities to progress YOUR career.
  • Accountable to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
  • Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Serves as an expert in ICH GCP and GSK written standards.
  • Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Requirements

  • Bachelor's degree: BA or BS OR 10+ years of clinical/clinical operations experience
  • Experience with leading and managing multiple complex design studies such as master protocols of umbrella, basket and platform trial designs.
  • Stakeholder management skills required as the role includes interactions with external clinical site staff and senior stakeholders at a central or local level.
  • Demonstrates track record in quality decision-making and problem resolution.
  • As required, assists with audits/inspections of local clinical operations department and study / sites in the US.
  • As required, prepares the local Informed Consent Form and coordinates the submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs).
  • All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.

Nice to have

  • If you have the following characteristics, it would be a plus:
  • Master of Science, PhD or equivalent coupled with previous project management experience.
  • Effective problem solving, negotiation and conflict resolution skills in a matrix environment
  • Deep knowledge of human research regulations in the US, IND/GCP/ICH-guidelines and GSK SOP/POL/guidelines
  • Available and willing to travel as job requires.
  • Strong written and verbal communications skills.
  • We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.
  • We focus on four therapeutic areas: respiratory, immunology and inflammation

Skills

  • The US annual base salary for new hires in this position ranges from $115,500 to $192,500.
  • Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
  • Uniting science, technology and talent to get ahead of disease together.
  • GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
  • GSK is an Equal Opportunity Employer.
  • Important notice to Employment businesses/ Agencies
  • GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
  • This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements.
  • For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Compensation

  • The US annual base salary for new hires in this position ranges from $115,500 to $192,500.

Benefits

  • At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.
  • respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

Equal opportunity

  • If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com
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