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01/04 Kimberlee
HR Manager at GSK

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GSK - Senior External Data Acquisition Specialist (6-11 yrs)

Bangalore Job Code: 909237

- The Senior 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.

- This role also acts a Process/Business owner for vendor solutions and related processes.

- 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

- Has the accountability for one or several complex studies and has the ability to manage the delivery of any type of studies (different areas, complex/unusual early setting, new/unusual indication, pivotal / Phase III and efficacy studies, clinical as well as epidemiology)

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 Process/Business owner, is responsible for one or more Vendor Data Acquisition processes, associated written standards, leads the implementation or improvement of new processes trainings, vendor selection & quality assessments, audits and inspections related to Vendor Data Acquisition.

- Acts as mentor in their expertise area to shorten the learning curve of the more junior profiles and act as a reference model within the Vendor Data Acquisition team

Why you?

Basic Qualifications:

- We are looking for professionals with these required skills to achieve our goals:

- Masters in Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent

- Minimum 6 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

Why GSK?

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:

- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.

- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

- Continuously looking for opportunities to learn, build skills and share learning

- Sustaining energy and well-being.

- Building strong relationships and collaboration, honest and open conversations.

- Budgeting and cost-consciousness.

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.

Note: For your candidature to be considered on this job, you need to apply necessarily on the redirected career page of the company as well

Women-friendly workplace:

Maternity and Paternity Benefits

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