Principal Country & Site Activation Manager

The Country & Site Activation role is responsible for providing customer-focused execution of the operational strategy and management of start-up activities for studies but may also be assigned to manage whole programs of work. This includes the overall management and oversight of the following processes: country & site activation and regulatory approval.

This role also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation. This position will primarily work with Local Delivery Leads in the LOCs, SDLs in Rx and Vx Delivery and the Feasibility Managers and GMASE SSU Teams. 

Principal Country & Site Activation Manager, fixed-term 12 month

Responsibilities:

• Lead study level country and site start-up activities by understanding the study objectives and assist/deputise for the CSA STOM Lead in the development of the global plan for country and site activation

• May act as the STOM squad lead dependent on experience

• Oversees day to day delivery of all aspects of global country site activation in the projects assigned

• Ensures that each project has a country and site activation plan and that country activations are planned in a single wave to maximise start up performance across all countries selected for a trial

• Meets the study timelines and expectations and complies with SOPs, reporting norms, appropriate regulations, and GSK's quality standards

• Input into project update and status calls, and other communications

• Utilize project management skills to optimize performance and collaboration to ensure successful study outcomes

• Developing appropriate early warning systems of potential obstacles to the successful completion of study start-up; analyses information and develops innovative solutions to challenges

• Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps

• Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research

• Contribute to process improvement efforts both within the department and in cooperation with other departments

• Transition oversight accountabilities to the SDL at the end of the start-up phase

Why You?

Qualifications:

• Bachelor’s degree - Business, Science or Math, Study Management, Clinical Operations or related discipline

• Significant clinical operations experience preferably across multiple TAs and phases of development in Rx and Vx

• Experience of being a senior Study Start Up Lead/SSU Team Leader or have been involved with leading the delivery of clinical studies

• Experience analysing data to optimize clinical trial delivery and to create various scenarios to support the operational design of a trial

Why GSK?

We offer:

• Important, established and interesting job in one of the leading global healthcare companies

• Possibility to work with engaged and enthusiastic people from various locations

• Opportunity to work in a professional team, playing crucial role in supporting GSK portfolio worldwide

• Access to newest technologies and solutions.

• Possibilities of development within the role and company’s structure

• Attractive reward package (annual bonus, awards for outstanding performance, rewards and recognition program, private medical healthcare, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance)

• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

• Extensive support of work life balance (flexible working solutions, remote work, short Fridays option, health & well-being activities). 

• Supportive community and integration events

Inclusion & Diversity at GSK: 

Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career. GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant. We want to hear from you and support with any adjustments that you may require during the recruitment process. Please g