Principal Country & Site Activation Manager

Job Purpose:

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.

Key Responsibilities:

The responsibilities include but are not limited to the following:
• Lead in the development and delivery of the global plan for country and site activation
• Ensures that critical study timelines related to Study Start-Up activities are achieved and that relevant cycle times, data and audit quality are met.
• Provides troubleshooting and problem resolution support for department to ensure productive, efficient contribution to study delivery.
• May act as the STOM working group 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 startup; 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 Significant clinical operations experience preferably across multiple TAs and phases of development in Rx and Vx.
• Have worked in a Study Start Up or Country & Site Activation team.
• Experience analyzing data to optimize clinical trial delivery and to create various scenarios to support the operational design of a trial.

Knowledge/Education Required:

Bachelors degree:

Business, Science or Math,
Study Management, Clinical
Operations or related discipline

Basic Qualifications/Experience:

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?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an equal opportunity employer committed to diversity and inclusion.  We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected].  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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