Position Summary

The Study Start-up Lead 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).

This position works directly with Clinical Operations Head, LDL Managers, SEL/LDL, STEP team, CRO FSP (Functional Service Provider) Managers and/or BDL where appropriate, in setting priorities and expectations for Study Start-Up.

Key Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Accountable to ensure timely start-up of all clinical studies across multiple therapeutic areas to agreed start up timelines according to set metrics, budget and quality target working according to country/regional (where appropriate) regulations, GSK SOPs and ICH GCP.
• Support operations between the central GSK study team, global SSU team and within-country study team for study start up activities.
• Ensures that critical study timelines related to study start up activities within-country are accurately forecasted.
• 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.
• Accountable for the delivery of country feasibility, site selection, recruitment planning, site training and/or regulatory package completion.
• 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.
• Actively works with stakeholders to simplify/optimize processes as it relates to their area of expertise. Responsible for identifying and sharing best practices.
• 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 performance and continually improves future activities.
• Leverages AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations.
• Supporting the site engagement lead (SEL) with site activation timelines

Why You?

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area.
• 3+ years of experience in clinical operations or similar positions in the pharmaceutical industry.
• Experience with ICH-GCP, local regulations, and regulatory processes.

Preferred Qualification
If you have the following characteristics, it would be a plus:

• 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.
• Experience with reviewing and creating Informed Consents.
• Strong written and verbal communication skills.

#GSK-LI

Skills
Agile Thinking, Business Acumen, Clinical Development, Clinical Research, Clinical Sciences, Clinical Trial Designs, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, Pharmaceutical Industry, Project Management, Time Management

The US annual base salary for new hires in this position ranges from $115,500 to $192,500. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.