Über diese Manager, Data Management Stelle bei GSK
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.
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.
Skills
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.
Inclusion at GSK:
As an employer committed to Inclusion, 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.
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.
It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.
GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing [email protected], so that we can confirm to you if the job is genuine.
