US Study Start Up Lead

Role 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. 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.

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

Qualifications

• Required: Bachelors in a General Science Degree (i.e. life science, medicine, clinical research, pharmacy)
• Required: 5 or more years‚Äô work experience in clinical operations

Preferred Qualifications

• Previous Oncology and Study Start Up experience strongly preferred
• Profound operational knowledge of clinical research with experience in all stages of study lifecycle and understanding of R&D process
• Good written and verbal communication skills in local language and in English
• Strong computer skills: advanced/expert level of MS Office (PowerPoint, Excel, Word and Outlook)
• Working knowledge of current clinical trial regulation
• Solid experience regarding management of contracts
• Given the nature of the job and accountabilities for local execution, project management skills are required to coordinate across all deliverables and manage local study teams to meet time, cost and quality requirements

Skills

• Project management
• Clinical operations leadership
• Regulatory and site start-up processes
• Cross-functional collaboration
• Vendor and contract management