US Study Start Up Lead

Study Start Up Lead

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. The role is the accountable person and single point of accountability for the study Start Up Metrics. This position works directly with Study Start Up Associate Director, LDL Managers, LDL, Global SSU Managers, CRO FSP (Functional Service Provider) CRA / CSA Managers in setting priorities and expectations for Study Start-Up.

Key Responsibilities :

• Accountable to lead 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 regulations, GSK SOPs and GCP.
• Serves as the operational point-of-contact 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 and maintains clear internal team communication and documentation.
• Accountable via the Study Start-up Coordinators for delivery of country feasibility, site selection, recruitment planning, site training and regulatory package completion.
• Facilitates communication within the clinical team (e.g. Budget and Contracts team, Clinical Supplies, Regulatory, and monitoring) during site start up, closely monitoring site visit schedule to ensure site activation timelines are met.
• Accountable for study recruitment vendor relations and engagement including strategy for country recruitment strategy.
• Accountable for including clinical trial diversity planning in country and site feasibility and selection.
• Responsible for standardizing processes, identifying, and sharing best practices and representing his / her team on internal and cross functional process improvement teams.
• Consulted for administrative approach to PEER sites.
• Represent GSK in key events (i.e Forum, Symposium, Trade Association, etc) and discussion related to the development of clinical research activities / investigator partnerships.
• Is the point of contact for the FSP CRO Line Manager in charge of study management through the FSP (Full-Service Provider) model, providing / capturing regular feedback for assuring study delivery and sharing best practice.
• Accountable for managing locally all clinical operational aspects related to the Regulatory Vault approach.

Basic Qualifications :

Preferred Qualifications :

The US annual base salary for new hires in this position ranges from $112,500 to $187,500. 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.

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.

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