Study Manager
Study Manager
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Job Description
Are you a clinical research professional keen on further development in global study delivery operations
Would you enjoy shaping a new organization driving innovation and being accountable for impact
If yes come and join us!
Warsaw Global Study Delivery Management Team is continuously and rapidly expanding. We were established in March 2021 and since then we have grown up since then.
Study Manager (G8
As an SM you will work with your international colleagues in collaboration with the Study Delivery Lead (SDL) to provide end to end operational and administrative support for study delivery activities. You will deliver activities for project(s) across different therapeutic areas including pivotal phase IIV efficacy studies just to name a few.
SM plays a key role in study operations and is expected to apply their judgement and take riskbased approach to make independent decisions withminimal guidance from SDL.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Manage study of trial(s) from startup through closeout in accordance with study budget and timelines
Study teams communication/meetings tracking progress and assessment of risks to timelines orquality of study delivery
Core member of study team supporting SDL in quality and data oversight toensure inspection/audit readiness includingoversight of eTMF completeness
Set up and maintenance of clinical trialmanagement systems and tracking tools
Preparation and update of study documentsand study plans
Vendor management
Country oversight
Risk management
Clinical supplies and recruitment materialsmanagement
Coordination of study budget
Why you
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
University scientific degree or another related field
Relevant experience in the global study management(within the Pharmaceutical Industry clinical operations and project management)
Experience in study management process of research studies
Good knowledge of and skill in applying applicable clinical research regulatory requirements i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (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 influencing skills and conflict resolution skills
Understanding of basic finance and accounting principles to work with budget
Proficiency in Microsoft Office suite (Excel PowerPoint Word Outlook OneNote etc.
Preferred Qualifications:
If you have the following characteristics it would be a plus:
Able to think independently analyze and solve problems systematically and creatively and able to take a riskbased approach
Quality mindset critical sense attention to details. Promotes a total quality culture
Effective communication skills (oral & written) and interpersonal skills
Acts as role model in line with GSKs 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
Able to think independently analyze and solve problems systematically and creatively and able to take a riskbased approach
Quality mindset critical sense attention to details. Promotes a total quality culture
Effective communication skills (oral & written) and interpersonal skills
Acts as role model in line with GSKs 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
Why GSK
At GSK we offer a wide range of additional benefits:
Career at one of the leading global healthcare companies
Hybrid work 2/3 days per week from the office)
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 (internal trainings mentoring access to online training platforms: Keep Growing Campus LinkedIn Learning Business Skills Harvard Manage Mentor Skillsoft and external training)
Extensive support of work life balance (flexible working solutions short Fridays option health & wellbeing activities).
Supportive community and integration events
Modern office with creative rooms fresh fruits every day
#LIGSK
#LIHYBRID
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 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. We prevent and treat disease with vaccines specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas (infectious diseases HIV respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome valued and included. Where they can keep growing and look after their wellbeing. So if you share our ambition join us at this exciting moment in our journey to get Ahead Together.
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.
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 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. 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:
Manager
Employment Type
Full-Time
Key Skills
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