Senior Data Management Quality Leader

2 tygodni temu

Warszawa, Mazovia, Polska BBSTEM Ltd. Pełny etat

We are looking for experienced and dynamicSenior Study Data Management Quality Leader (Sr DMQL) who will be part of the Data Management group within our constantly growing GSK R&D Polish Hub. This role is focused on expert oversight on DM deliverables and strong E2E leadership together with CRO vendor management component.

Role location: Warsaw HUB office, where GSK can offer you the best flexible hybrid model of work – both home and office based.

Responsibilities:

Oversight of end-to-end Data Strategy and Management (DS&M) for one or several complex studies, delivered by DM Functional Service Provider (FSP) or Full Service Outsourced (FSO) studies to the agreed quality, timelines and budget

Study level contribution, working in close collaboration with other key members of the internal and external study team

Point of contact for data management and data quality considerations for GSK and CRO stakeholders

Providing input to protocol and other GSK plans, e.g., Monitoring Plan, Protocol Deviation Management Plan, Reporting & Analysis Plan and Data Management Plan (or equivalent), during the planning phase

Oversight of in-stream data flow activities,with accountability for clean database delivery in accordance with the Data Management Plan or equivalent

Provides expert opinion into the electronic and external data capture tools design, including eCRF, eCOA, etc

Managing vendor performance against study-specific Service Level Agreements.

Acts as mentor and SME for DS&M team

Why You?

What skills and expertise you will bring to the role:

Relevant education degree from Scientific Discipline (Biomedical or Computer)

Min. 5 years of data management/clinical trials experience in Pharma, CRO and/or ARO

Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP)

Fluent English, both spoken and written

Good communication skills, verbal and written, ability to effectively communicate and maintain strong working relationships in global teams at all levels of the organization

Demonstrated project management ability to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets

Understanding of laboratory data including biomarker data

Experience of InForm, RAVE and/or Veeva EDC systems will be an advantage

Experience working with key global preferred suppliers/ partnerships, to ensure deliverables are to the agreed standard

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

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)

Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).

Supportive community and integration events

Modern office with creative rooms, fresh fruits every day

#LI-GSK

#LI-HYBRID

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, it's 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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or 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.

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. 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 GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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