Clinical Operations Submissions Specialist

Leads the co-ordination and delivery of specialized operational activities according to ICH GCP, international and local regulations, and relevant GSK written standards. The Clinical Operations Submissions Specialist plays a pivotal role as a member of the local clinical study team and is responsible for contributing to the planning, execution, and delivery of the Clinical trial in the country.

In this role you will be…

• Responsible for determining the most appropriate submissions strategy for the study in collaboration with study team. Provides consult to the study team to ensure best possible outcome for Clinical Trial Applications (CTAs) following EU CTR.
• Accountable for the timely delivery of local regulatory and/or ethics submission content in collaboration with local and central study teams and global/local regulatory team if applicable
• Responsible for the preparation, collation, review, tracking and filing of all documentation required for regulatory and/or ethics committee submissions. This may include Informed Consent form review, coordinating translations, preparation of study and site documents required for central/national submissions.  As needed, coordinates the support of Clinical Support Specialists in preparation, tracking system updates and filing of documents
• Ensure all submission requirements are met in timely manner throughout the study; maintains communication with National Competent Authority and provide support for Part 2 Request for Information (RFI) responses if needed
• Connects with local internal and external experts to keep up to date with changes in regulations or submission requirements. Learns from past submission outcomes and continually improves future submissions. Where applicable, become an active member in local external think tanks, bodies, agencies to support the local simplification and/or acceleration of regulatory and/or ethics committee submission process

Why you?

We are looking for professionals with these characteristics to achieve our goals:

• Bachelor’s degree or equivalent. Any general science degree e.g. life science, medicine, clinical research, pharmacy etc.
• Experience in EU CTR Part II submissions and proficiency with the CTIS platform
• Strong understanding of global and local clinical trials regulations and start-up processes
• Advanced English (verbal and written)
• This role interfaces with external authorities, suppliers, and customers and must be able to convey GSK positions and requirements to a highly experienced external partner group
• Able to manage priorities working across several trials and study teams. 
• Accountability for own actions/decisions. Able to work independently as well as in a team
• Recognizes potential obstacles or risks and works proactively to resolve them within set timelines. Escalates issues appropriately, articulating the actions required from members of the team
• Able to delegate and distribute workload effectively to avoid delays
• Conscientious and high-quality delivery of work even when under pressure. 
• Effective at technical problem solving
• Professional attitude with good customer focus (internal and external). 
• Flexible and responsive to new ideas in a changing environment

Why GSK?

At GSK we offer a wide range of additional benefits:

• Career at one of the leading global healthcare companies
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Hybrid working model (where GSK site are in Poland)
• Extensive support of work life balance (flexible working solutions, min. 2-3 days/week working form the office, short Fridays option, health & well-being activities)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure
• 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)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits every day

We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team ([email protected]) to further discuss this today.

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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/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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