US Study Start Up Lead

GSK

2d•$115,500 - $192,500•Remote

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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