Study Manager
Posted Date: Apr 14 2023
In GSK we’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.
In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.
Find out more:
Warsaw Global Study Delivery Management Team is continuously and rapidly expanding! We have been established in March 2021 and since than we grew up to 50 team members.
Our team operates at the heart of R&D HUB, increasing its impact on excellence in study delivery and working together will various clinical operation functions towards patients well-being.
Together we are creating extraordinary culture – come and join us!
We are looking forStudy Managers (SM). As the SM, you will work in collaboration with the Study Delivery Lead (SDL) to provide end to end operational and administrative support for study delivery activities. You will be responsible for performing activities for one or several projects, and you will have to ability to support most types of studies (different therapeutic areas, pivotal/critical path, Phase III, efficacy studies just to name a few). Moreover, you will act as a role model in the clinical trial process, and you will coach and mentor less experienced SDSs.
SM works in close partnership with SDL, SMshould beable to apply their judgement andtake risk-basedapproach to make independent decisions withminimal guidance from SDL.
Corescope:
- Delivery of study to plan, including managingthe study team’s communication/meetings, tracking progress and themonitoring/assessment of risks to timeliness orquality of study delivery
- Supporting SDL in quality and data oversight toensure inspection/audit readiness, includingoversight of eTMF completeness
- Setting up and maintaining clinical trialmanagement systems and tracking tools
- Preparationand update of study documentsand study plans
- VendorManagement
- CountryOversight
- Risk management
- Clinical supplies and recruitment materialsmanagement
- Coordination of the study budget
Basic Qualifications:
- University Scientific Degree or another related field
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i. e. , Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Ability to manage multiple competing priorities within various clinical trials with good planning, time management and prioritization skills
- Good understanding of the principles of project planning & project management
- Proven negotiation and influencing skills and effective at conflict resolution
- Understanding of basic finance and accounting principles in order towork with budget
- Tools knowledge like Microsoft office (Excel, PowerPoint, Word, Outlook, etc. )
Preferred Qualifications:
- Able to think independently, analyse and solve problems systematically and creatively and able to take a risk-based approach
- Quality mindset, critical sense, attention to details. Promotes a total quality culture
- Good communication skills (oral & written) and interpersonal skills
- Acts as role model in line with GSK core values and expectations
- Effective training and mentoring skills
- Able to take decisions and resolve issues
- Team spirit and ability to work across cultures and geographies with a high awareness and understanding of cultural differences
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)
- Extensive support of work life balance (flexible working solutions, min. 4 days/month 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
#LI-GSK
#LI-HYBRID
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2. 5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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