GSK
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This role mentors other DS&M team member(s) and acts as Subject Matter Expert.
Clinical Data Management is responsible for overseeing the end to end DS&M study related activities and is accountable for all DS&M study deliverables in terms of quality & delivery to plan. This role mentors other DS&M team member(s) and acts as Subject Matter Expert.
Key Responsibilities (No More than 10 Bullet Points): Describe
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
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.
May oversees and provides input to the development of budgets forecasts for FSP and FSO contracts.
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
Develops and maintains excellent professional relationships with study team and other key stakeholders
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
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Bachelor’s degree in a scientific, clinical, computer, or related discipline.
Minimum of 4 years’ experience in data management or clinical trials within pharmaceutical, contract research organization (CRO), or academic research settings.
Practical knowledge of Good Clinical Practice and regulatory requirements for clinical data management.
Experience managing relationships and oversight with external vendors or service providers.
Strong English communication skills, both written and verbal, for effective global collaboration.
Proven ability to plan and deliver study-level activities and timelines.
#LI-GSK
#LI- Hybrid
Agile Thinking, Clinical Data Management, Clinical Development, Clinical Information Systems, Clinical Trial Designs, Communication, Creativity, Data Analysis, Data Management, Data Standards, Data Validation, Influencing Without Authority, Risk Management, Stakeholder Management, Teamwork
Polish Salary Range / Polski przedział wynagrodzenia: PLN 255,750 to PLN 426,250The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. 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 candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.Roczny przedział wynagrodzenia zasadniczego brutto dla nowo zatrudnionych osób na tym stanowisku został wskazany powyżej dla każdej właściwej lokalizacji. Przedziały te uwzględniają szereg czynników, w tym umiejętności kandydata, doświadczenie, poziom wykształcenia oraz rynkowy poziom wynagrodzenia dla tego stanowiska W zależności od stanowiska i obowiązujących polityk wewnętrznych, rola ta może również uprawniać do otrzymania premii (jeśli ma zastosowanie i jest przyznawana na podstawie określonych, obiektywnych kryteriów) oraz/lub nagród za wyjątkowe wyniki (przyznawanych według uznania pracodawcy). Wszystkie świadczenia ustawowe będą zapewnione zgodnie z przepisami prawa polskiego. Mogą być także oferowane dodatkowe benefity, takie jak prywatna opieka medyczna, dodatkowe płatne dni wolne, ubezpieczenie na życie, prywatny plan emerytalny oraz w pełni płatny urlop rodzicielski i urlop na opiekę nad członkiem rodziny. Bardziej szczegółowe informacje na temat całkowitego pakietu wynagrodzenia i świadczeń przypisanego do tego stanowiska zostaną przekazane podczas procesu rekrutacyjnego. Przedziały wynagrodzenia dla innych krajów mogą być również widoczne, ponieważ na niektórych rynkach obowiązują przepisy dotyczące jawności wynagrodzeń, które wymagają zamieszczania takich informacji w ogłoszeniach o pracę, a wskazane lokalizacje mogą stanowić potencjalne miejsce wykonywania tej roli. Jeśli przedział wynagrodzenia nie jest podany w ogłoszeniu dla konkretnej lokalizacji lub kraju, odpowiednie informacje o wynagrodzeniu zostaną omówione w trakcie procesu rekrutacyjnego. Prosimy pamiętać, że poziom wynagrodzenia różni się w zależności od kraju i jest ustalany na podstawie umiejętności, doświadczenia, poziomu wykształcenia oraz rynkowego poziomu wynagrodzenia dla danego stanowiska. Oferty są zazwyczaj przedstawiane w granicach wskazanego przedziału, z uwzględnieniem umiejętności, doświadczenia i kwalifikacji kandydata, przy czym górna granica jest zwykle zarezerwowana dla kandydatów o bardzo dużym doświadczeniu lub w innych wyjątkowych okolicznościach zgodnych z tymi kryteriami.
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 pl.recruitment-adjustments@gsk.com to discuss your needs.
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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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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
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