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Study Manager
4 giorni fa
As Study Manager you will lead and coordinate the delivery of clinical and evidence generation studies from planning through close-out. You will work with study teams, vendors, and country colleagues to keep studies on time, on budget, and compliant with standards. We value clear communication, practical problem solving, and a focus on quality. This role offers growth through exposure to global study delivery, the chance to shape ways of working, and meaningful impact aligned with our mission of uniting science, technology and talent to get ahead of disease together. Responsibilities Monitor study conduct and progress; identify, resolve and escalate risks/issues. Draft and review key clinical documents (Protocol, ICF) and study plans. Coordinate meetings and collaboration with internal teams and external partners (CROs, vendors). Support GSM in CRO oversight and delivery of delegated activities. Serve as primary vendor contact for study-specific deliverables. Provide country-level oversight: recruitment, data completeness, deviations, regulatory compliance. Manage study communications: meetings, newsletters, action logs and team rosters. Oversee clinical supply and investigational product delivery; identify risks and propose mitigations. Ensure eTMF inspection readiness; maintain completeness and quality of study documentation. Oversee budget tracking, change orders and expenses; ensure alignment with agreements and escalate issues. Actively contribute to Study Leadership and Central Study Teams; foster team dynamics and change adoption. Why You? This role is hybrid. You will be expected to work regularly from our office and collaborate with international colleagues. Basic Qualifications At least 3+ years of relevant work experience in a pharmaceutical/scientific environment. Knowledge of clinical trials, drug development process. Strong knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards. Well familiar with key systems used in clinical trial delivery. Experience in using Trial Master File industry accepted standard. Project management skills (preferably with analytical/financial skills) and good leadership skills. Excellent verbal and written communication in English. Strong knowledge of, and skills in applying, applicable clinical trial regulatory requirements, i.e. GCP and ICH guidelines. Ability to manage multiple competing priorities with leadership guidance across various clinical studies with good planning, time management and prioritization skills. Logical/analytical thinking and an inclination to spot patterns and outliers. Quality mindset, critical sense, attention to details, effective training and mentoring skills. Knowledge of project finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports. Excellent comprehension of Microsoft Office tools and CTM systems. Good stakeholder management and communication skills (oral and written), strong interpersonal skills. Results driven and efficient. Ability to adjust to work in cross-functional squads in the agile model. What we offer Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours. Established job in an international, well-known pharmaceutical company. Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets. Opportunity to work within GSK standards and documentation applied globally. Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus). Supportive & friendly working environment. 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. 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. EQUITY STATEMENT 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. #J-18808-Ljbffr
