GSK - External Data Acquisition Specialist (3-7 yrs)
- The External Data Acquisition Specialist is primarily responsible for the technical acquisition of vendor data for clinical and epidemiological studies managed internally. This role ensures vendor solutions are consistent and comply with company and industry standards with respect to quality and timelines.
- Responsible for the technical & vendor oversight of multiple data types (Central Labs, RNA/DNA sequencing, Flow Cytometry, Complex Biomarkers, eCOA, Microscopy, Immunohistochemistry, Ocular assessments, Imaging, etc) for one ore more clinical & epidemiology study(ies) managed internally
For the studies he/she:
- Acts as a key point of contact or/and an advisor for key stakeholders and the Study Core Teams (SCT) members - including the Study Data Manager for vendor technical activities & matters
- Coordinates review, revision, and approval of study specification documents (including operational requirements & specifications) and key vendor deliverables (including translations)
- Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate
Ensures quality control and quality audit of deliverables, Understands, mediates, and solves issues related to Vendor Data acquisition and escalates as appropriate to the Study Data Manager or Vendor
- As a Subject Matter Expert (SME), contributes to the implementation of new Vendor Data Acquisition processes, associated written standards, trainings, vendor selection & quality assessments, audits and inspections
- We are looking for an experience individual and if you have these skills, we would like to speak to you.
- Masters in Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent.
- Minimum 3 years in similar or related job experience in Clinical Research or Information Systems and/or relevant scientific experience
- Experience required to deliver assigned clinical data management tasks in-line with expectations in terms of time and quality and in compliance with DM processes
- Experience required to be able to act as SME, mentor and technical advisor on complex concerns
- A sufficient level of autonomy is expected in highly complex study set-up with multiple stakeholders
- Experienced in Data Management in the pharmaceutical industry,
- Experience of managing business remotely in a matrix network
- Understanding of general data flow & database architecture concepts
- Good understanding of regulations including ICH-GCP
- Knowledge of multiple programming languages (PL/SQL, SAS, Python, C#, etc)
- Experience working in database systems and environments, including Oracle and Unix
- Ability to explain complex technical principles to non-technical staff
- Experience developing programmatic transformations of clinical laboratory data
- Knowledge of medical terminology related to biospecimen collection and assessment
- Experience with SDTM CDISC standards
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities, Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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