[Hiring] Study Start-Up Lead @GSK

Role Description

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 is 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
• Accountable for study start-up metrics

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

Key Responsibilities include:

• Ensure timely start-up of all clinical studies across multiple therapeutic areas to agreed start-up timelines according to set metrics, budget, and quality targets.
• Support operations between the central GSK study team, global SSU team, and within-country study team for study start-up activities.
• Ensure critical study timelines related to study start-up activities within-country are accurately forecasted.
• Maintain internal tracking for study site status from initial site contact through site initiation.
• Deliver country feasibility, site selection, recruitment planning, site training, and/or regulatory package completion.
• Coordinate activities and prepare, collate, review, track, and file all documentation required for study start-up.
• Work with stakeholders to simplify/optimize processes.
• Connect with local internal and external experts to keep up to date with changes in site start-up requirements.
• Leverage AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations.
• Support the site engagement lead (SEL) with site activation timelines.

Qualifications

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

Requirements

• 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.

Benefits

• US annual base salary ranges from $115,500 to $192,500.
• Annual bonus and eligibility to participate in share-based long-term incentive program.
• Health care and other insurance benefits (for employee and family).
• Retirement benefits.
• Paid holidays and vacation.
• Paid caregiver/parental and medical leave.