Local Study Startup Specialist

Job Purpose:

Leads the co-ordination and delivery of specialized operational activities according to ICH GCP, international and local regulations, and relevant GSK written standards. The Local Study Startup Specialist plays a pivotal role as a member of the local clinical study team and is responsible for contributing to the planning, execution, and delivery of the Clinical trial in the country.

Key Responsibilities :

Co-ordinating the management and execution of start-up activities in country

• Accountable to lead and collaborate with the Local Delivery Lead and Local Clinical Operations Specialists to ensure timely Start-up of all clinical trials across multiple therapeutic areas to agreed start up timelines according to ICH GCP, international and local regulations, and relevant GSK written standards.
• 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.
• Responsible for efficient coordination of activities and may be responsible for the preparation, collation, review, tracking and filing of all documentation required for study start-up. This may include Informed Consent form review, coordinating translations, preparation of central ethics submissions, delivery of documents to sites for local ethics committee submissions. As needed, coordinates the support of Local Clinical Support Specialists (LCSS) in preparation, tracking system updates and filing of documents.
• Actively works with stakeholders to simplify/optimize processes as it relates to their area of expertise
• Connects with local internal and external experts to keep up to date with changes in site start-up requirements. Learns from past site activations and continually improves future activities.
• Coaching and mentoring of new study team members as required

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In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD91,000 to CAD141,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.

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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. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. 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; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. 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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com.  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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