Associate Director Global Study Lead

The Global Study Lead will lead the planning and delivery of a global clinical study and work with cross-functional teams across clinical development, data management, safety, regulatory and external partners. We value clear decision-making, practical problem solving and a collaborative approach. This role offers visible impact, strong learning opportunities and the chance to help deliver work that advances GSK’s mission of uniting science, technology and talent to get ahead of disease together.

Key Responsibilities:

• Provide oversight and support to the appropriate teams on end-to-end clinical study delivery.
• Serves as the point of escalation for Clinical Operations.
• Ensure compliance with ICH [International Council for Harmonisation] /GCP [Good Clinical Practice] guidelines, all applicable laws and regulations, and GSK SOPs [Standard Operating Procedure] for assigned studies. understand study contribution to program/submission.
• Accountable for translating asset requirements to the study and appropriate communication with the Clinical Operations Asset Lead
• Balance risk/benefit to make decisions based on clear understanding of impact on the study and project.
• As the SLT [Senior Leadership Team] escalation point for clinical operations, support the Working Groups leads to proactively and effectively identify, oversee, and mitigate study risks.
• Ensure appropriate stakeholder communication, including study status, expectations, risks and issues.
• Ensure robustness in upfront feasibility and planning
• Preparation of materials for governance and / or financial review cycles.
• Effectively build and lead empowered matrix teams.
• Provide strategic oversight on operational input into protocol and informed consent form development, and other key study documents.
• Oversee quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.
• Lead / contribute to ways of working and process improvement initiatives.
• Leads assessment and selection of FSO [Full-Service Outsourcing] vendors in collaboration with COAL [Clinical Operations Asset Lead] and be an escalation point for vendor issues.
• Ambassadors in increasing utilisation of AIML [Artificial Intelligence & Machine Learning] tools, driving automation of manual processes, finding efficiencies and more effective ways of working.

Basic Qualifications:

• Bachelor's degree in life sciences, pharmacy, nursing, or related field.
• Minimum 5 years’ experience in clinical operations or study management within pharmaceutical industry or CRO [Contract Research Organization].
• Experience in leading global study set-up and delivery with multi-country execution.
• Experience with ICH/GCP and applying global regulatory and safety requirements along with stakeholder management
• Experience in project planning, risk management and standard clinical trial systems or tools.
• Experience in delivering verbal and written communication in English language.

Preferred Qualifications:

• Advanced degree in life sciences, clinical research, or in these related field.
• Experience with complex or adaptive study designs and/or real-world evidence studies.
• Experience managing outsourced vendors and CRO oversight.
• Experience with implementing process improvements or efficiencies in study delivery.
• Experience with electronic data capture, data management oversight or medical review activities.
• Experience working in cross-functional matrix teams.
• Previous secondment experience or history of working in temporary global assignments.

Work Arrangement:

This role offers a hybrid working model, with a mix of on-site and remote work.

Why GSK?

• 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).
• Extensive support of work life balance (flexible working solutions, min. 2-3 days/week working form the office, health & well-being activities).
• Life insurance and pension plan.
• Private medical package with additional preventive healthcare services for employees and their eligible.
• Sports cards.
• Possibilities of development within the role and company’s structure.
• Personalized learning approach.
• Supportive community and integration events.

#LI-GSK

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Skills

Agile Thinking, Business Acumen, Clinical Development, Clinical Trial Designs, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, People Management, Pharmaceutical Industry, Project Management, Time Management

 

 

Polish Salary Range / Polski przedział wynagrodzenia: PLN 320,250 to PLN 533,750The 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 candidate’s skills, experience, education level and the market rate for the role. In 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 candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.Roczny 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 pl.recruitment-adjustments@gsk.com 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 we’re 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.

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