Clinical Operations Submissions Specialist

Job description

Nombre del sítio: Warsaw, Poznan
Fecha de publicación: Feb 16 2024

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.

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.

· 
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. 

· 
Previous experience at GSK would be a plus.

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.

GSK is an INCLUSIVE and DIVERSE employer. If you require any adjustments during recruitment process let us know: pl.recruitment-adjustments@gsk.com .

Si necesita una adaptación u otra asistencia para solicitar un trabajo en GSK, comuníquese con el Centro de Servicios de RR. HH. de GSK al 1-877-694-7547 (gratis en los EE. UU.) o al +1 801 567 5155 (fuera de los EE. UU.).

GSK es un empleador que cree en la igualdad de oportunidades y la acción positiva. Todos los solicitantes calificados recibirán la misma consideración para el empleo sin tener en cuenta la raza, el color, el origen nacional, la religión, el sexo, el embarazo, el estado civil, la orientación sexual, la identidad o expresión de género, la edad, la discapacidad, la información genética, el servicio militar, el estado de veterano cubierto o protegido o cualquier otra clase federal, estatal o local protegida.

Aviso importante a las empresas o agencias de empleo

GSK no acepta recomendaciones de empresas de empleo o agencias de empleo con respecto a las vacantes publicadas en este sitio. Todas las empresas o agencias de empleo están obligadas a ponerse en contacto con el Departamento de Contrataciones Comerciales y Generales o el Departamento de Recursos Humanos de GSK para obtener autorización previa por escrito antes de recomendar a cualquier candidato a GSK. La obtención de autorización previa por escrito es una condición precedente a cualquier acuerdo (verbal o escrito) entre la empresa o agencia de empleo y GSK. En ausencia de dicha autorización por escrito, se considerará que las acciones que emprenda la empresa o agencia de empleo se han realizado sin el consentimiento o el acuerdo contractual de GSK. Por lo tanto, GSK no será responsable de ninguna tarifa derivada de tales acciones o cualquier tarifa que surja de cualquier recomendación por parte de las empresas o agencias de empleo con respecto a las vacantes publicadas en este sitio.

Tenga en cuenta que si usted es un profesional de la salud con licencia de EE. UU. o profesional de la salud según lo definido por las leyes del estado que emite su licencia, puede ser necesario que GSK recolecte e informe los gastos en los que GSK incurre, en su nombre, en el caso de que se lo entreviste para el empleo. Esta recolección de las transferencias de valor aplicables es necesaria para garantizar el cumplimiento de GSK con todos los requisitos federales y estatales de Transparencia de los Estados Unidos. Para obtener más información, visite el sitio de Informe de Transparencia de GSK For the Record .