Clinical Operations Submissions Specialist
Job Location:
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
At GSK we have bold ambitions for patients aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to transform peoples lives. GSK fosters a culture ambitious for patients accountable for impact and committed to doing the right thing making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. Were uniting science technology and talent to get ahead of disease together.
Find out more:
Our approach to R&D
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 Specialist plays a pivotal role as a member of the local clinical study team andis responsible forcontributing to the planning execution and delivery of the Clinical trial in the country.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Responsible fordeterminingthe mostappropriate submissionsstrategy for the study in collaboration withstudyteam. Provides consult to the study team to ensurebestpossible outcomefor regulatory and/or ethics committee submissions.
Accountable for thetimelydelivery 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 central/national ethics submissions delivery of documents to sites for local ethics committee needed coordinates the support of Clinical Support Specialists in preparation tracking system updates and filing of documents.
Maintains communication with Regulatory Affairs/Minister of Health contacts National/Central Ethics Committee and sites to ensure all submission requirements are met intimelymanner throughout the study including request for information responses if needed.
Connectwith local internal and external experts to keep up to date with changes in regulations or submission requirements.Learnfrom past submission outcomes and continuallyimprovefuture 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.
Other Clinical Operation Specialist Responsibilities
Responsible for coordinating and updating information required for institutional reports and external stakeholders.
Could act as subject matter expert at the LOC for different applications applicable to their role.
Provide administrative support to the local GMASE department by coordinating meetings managing communication flows acting as the liaison between local and global teams and performing related administrative duties.
Leverages AI-enabled tools and digital solutions responsibly to improve efficiency data quality and decision-making in clinical trial operations
Why You
Working arrangement: This role is hybrid. You will be expected to work regularly from our Poland office and collaborate with international colleagues.
Basic Qualification
Masters / Bachelors degree or equivalent or atleast 2 years of experience in clinical operations or similar positions in the pharmaceutical industry.
Solid knowledge of ICH-GCP local regulations and regulatory processes.
Experience in EU CTR Part II submission and proficiency with the CTIS platform
Understanding of global and clinical trials regulations and start-up processes
What we offer:
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)
Life insurance and pension plan
Private medical package with additional preventive healthcare services for employees and their eligible counterparts
Sports cards (Multisport)
Possibilities of development within the role and companys structure
Personalized learning approach
Extensive support of work life balance
Supportive community and integration events
Modern office with creative rooms fresh fruits everyday
Free car and bike parking locker rooms and showers.
#LI-GSK
#LI-HYBRID
Polish Salary Range / Polski przedział wynagrodzenia: PLN 168000 to PLN 280000The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidates skills experience education level and the market rate for the addition this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidates skills experience education level and the market rate for the role. Offers are typically made within the advertised range based on the candidates skills experience and qualifications with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these przedział wynagrodzenia zasadniczego brutto dla nowo zatrudnionych osób na tym stanowisku został wskazany powyżej dla każdej właściwej lokalizacji. Przedziały te uwzględniają szereg czynników w tym umiejętności kandydata doświadczenie poziom wykształcenia oraz rynkowy poziom wynagrodzenia dla tego stanowiska W zależności od stanowiska i obowiązujących polityk wewnętrznych rola ta może również uprawniać do otrzymania premii (jeśli ma zastosowanie i jest przyznawana na podstawie określonych obiektywnych kryteriów) oraz/lub nagród za wyjątkowe wyniki (przyznawanych według uznania pracodawcy). Wszystkie świadczenia ustawowe będą zapewnione zgodnie z przepisami prawa polskiego. Mogą być także oferowane dodatkowe benefity takie jak prywatna opieka medyczna dodatkowe płatne dni wolne ubezpieczenie na życie prywatny plan emerytalny oraz w pełni płatny urlop rodzicielski i urlop na opiekę nad członkiem rodziny. Bardziej szczegółowe informacje na temat całkowitego pakietu wynagrodzenia i świadczeń przypisanego do tego stanowiska zostaną przekazane podczas procesu rekrutacyjnego. Przedziały wynagrodzenia dla innych krajów mogą być również widoczne ponieważ na niektórych rynkach obowiązują przepisy dotyczące jawności wynagrodzeń które wymagają zamieszczania takich informacji w ogłoszeniach o pracę a wskazane lokalizacje mogą stanowić potencjalne miejsce wykonywania tej roli. Jeśli przedział wynagrodzenia nie jest podany w ogłoszeniu dla konkretnej lokalizacji lub kraju odpowiednie informacje o wynagrodzeniu zostaną omówione w trakcie procesu rekrutacyjnego. Prosimy pamiętać że poziom wynagrodzenia różni się w zależności od kraju i jest ustalany na podstawie umiejętności doświadczenia poziomu wykształcenia oraz rynkowego poziomu wynagrodzenia dla danego stanowiska. Oferty są zazwyczaj przedstawiane w granicach wskazanego przedziału z uwzględnieniem umiejętności doświadczenia i kwalifikacji kandydata przy czym górna granica jest zwykle zarezerwowana dla kandydatów o bardzo dużym doświadczeniu lub w innych wyjątkowych okolicznościach zgodnych z tymi kryteriami.As an Inclusive employer we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at to discuss your needs.
Why GSK
Uniting science technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.
People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license GSK may be required to capture and report expenses GSK incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
IC
About Company
About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
