You will lead end-to-end oversight of clinical data management for studies based in Poland and across global teams. You will work with study teams, vendors and technical partners to ensure high-quality data, on-time delivery and regulatory compliance. We value clear communication, practical problem solving and a collaborative mindset. This role offers scope to influence data practices, mentor others and make a measurable contribution to our mission of uniting science, technology and talent to get ahead of disease together.

Key Responsibilities:
•Accountable for the end to end DS&M study related activities in terms of quality & delivery to plan which include:
- Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments
- Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation
- Interim and final cleaned database lock
- Archival of all DM documents in the eTMF
- Archival of the study database and provision of clinical data to the study site
• Accountable for one or several complex studies, and has the ability and experience to manage the delivery of any type of study (different therapeutic areas, complex/unusual early phase setting, new/unusual indication, pivotal/Phase III and efficacy studies, clinical as well as epidemiology studies)
• For an in-house study, leads the day to day DS&M operational study related activities, acts as a member of the study core team and is the single point of contact for all the DM study related activities & matters 
• For a study outsourced through a DM Functional Service Provider (FSP) or Full Services Outsourcing (FSO), conducts & documents sponsor oversight of the end to end FSP/FSO study related activities and ensures training on the protocol to the FSP resources working on the study
• Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register
• Provides reports, status updates, feedback and advice to key study stakeholders on study progress.
• Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these
• Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity
• Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level
• Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines
• Acts as a mentor for junior members of the DS&M team
• Acts as a Subject Matter Expert supporting the implementation of new processes, data standards, trainings, systems, vendor quality assessments, audits and inspections


Why You?
Basic Qualifications:
• Minimum of 4 years’ experience in clinical data management or clinical trials in pharma, CRO or academic research settings.
• Practical knowledge of Good Clinical Practice (GCP) and regulatory expectations for clinical data.
• Experience working with external vendors or Functional Service Providers and performing sponsor oversight.
• Pharma and/or CRO experience. 
• Understanding of disease area and laboratory data. 

#LI-GSK
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Working Model
This role is offered on a hybrid basis. You will be expected to work from our office part of the week and will have flexibility to work from home on other days. Exact hybrid pattern will be discussed during recruitment.


How to apply
If this role speaks to you and you want to grow your career while contributing to work that matters, please apply. We look forward to learning about your experience and how you would help improve clinical data quality and delivery. If you need adjustments during the application process, please contact our Recruitment Team to discuss your needs.

The annual base salary in Poland for new hires in this position ranges from PLN 255,750 to PLN 426,250 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. 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.

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 [email protected] 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.

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