Study Manager
5 ore 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.This role will provide YOU the opportunity to lead key activities to progress YOUR career.These responsibilities include some of the following: 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 contributes to Study Leadership and Central Study Teams; foster team dynamics and change adoption.Why You?Working arrangement This role is hybrid.You will be expected to work regularly from our office and collaborate with international colleagues.Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals 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 More detailed information on the total reward package applicable to your role will be supplied during the recruitment process.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 market rate for the role.In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices.The annual compensation for this role is CAD91,000 to CAD141,000 , determined based on experience, qualifications, and internal equity.GSK is dedicated to promoting transparency and fairness throughout our recruitment process.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.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 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.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 GSK's 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 GSK.In 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.
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Study Manager
2 giorni fa
Siena, Italia GlaxoSmithKline A tempo pienoAs 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...
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Study Manager
2 giorni fa
siena, Italia GlaxoSmithKline A tempo pienoAs 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...
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Study Manager
1 giorno fa
siena, Italia GlaxoSmithKline A tempo pienoAs 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...
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Senior Clinical Research Associate
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