Gsk

Gsk

Associate Director, US Study Start-Up

Home Worker - USA · Director

Sponsorship not specified$130k-$216kDetected 1 day ago
GCPProject ManagementNegotiationProcess ImprovementProcurementHRPerformance ManagementClinical TrialsClinical ResearchResearchLeadershipCommunicationCollaborationTime ManagementMentoringGxP

About the role

  • The Associate Director, Study Start-up is responsible for providing leadership in the execution of operational strategy and management of start-up activities for all clinical trials, across all therapy areas.
  • This includes, but it's not limited to the overall management and oversight of the following processes: preparation and submission of CTA for EC and CA, site contracts and TPRM for core and CRO-managed countries.
  • The role is the accountable person for the study start up metrics (these metrics can be shared with other directors/manager depending on local leadership roles, where appropriate).

Responsibilities

  • Support operations between the central GSK study team, global SSU team and within-country study team for study start up activities.
  • Accountable for maintaining internal tracking for study site status from initial site contact through site initiation. Maintains clear internal team communication and documentation to ensure site activation timelines are met.
  • Actively works with stakeholders to simplify/optimize processes as it relates to their area of expertise. Responsible for identifying and sharing best practices.
  • Accountable to lead Study Start Up Leads and/or Local Clinical Operations Specialists to ensure timely start-up, operational management, completion and delivery of all clinical studies across multiple therapeutic areas to agreed start up timelines according to UQ (Upper Quartile), budget and quality target working according to country/regional regulations, GSK SOPs and GCP.
  • Responsible for resource management and allocation to maintain business performance and a sustainable workload.
  • 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

  • Regular domestic travel will be required to build relationships and support study delivery.
  • Arranges appropriate training to ensure they have the skills and knowledge required.
  • 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

  • University degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area.
  • 5+ years of experience in clinical operations or similar positions in the pharmaceutical industry.
  • Solid knowledge of ICH-GCP, local regulations, and regulatory processes.
  • Experience managing study start-up activities across multiple sites in the US.
  • Advanced degree such as Master's, PharmD, or PhD
  • Demonstrated leadership skills and experience working in matrix teams.
  • Experience in budget control and monitoring of performance indicators.
  • Analytical skills and a results-oriented mindset, with a focus on operational efficiency and quality.

Skills

  • The US annual base salary for new hires in this position ranges from $129,750 to $216,250.
  • 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 $129,750 to $216,250.

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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