Bengaluru, Karnataka, India
Onsite
Job Purpose
This role is primarily responsible for data acquisition applications for clinical studies across Therapy Areas comply with company and industry standards, concerning quality and timelines. This role may have supervisory responsibility and/or oversight for a small team.
Key Responsibilities:
• Lead/Responsible for the study set-up, technical development of Electronic Data capture (eDC) solutions and associated tools for one or more clinical study(ies).
• Responsible for project delivery of multiple Clinical studies for all clinical data acquisition activities, including timeline management, oversight/governance of external vendors, driving team members to meet project timelines, etc.
• For studies, key responsibilities include:
o Act as an advisor for the Study Core Teams (SCT) members in providing DM. operational/requirements about the eDC study set-up or vendor technical related activities.
o Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate.
o Coordinates review, revision, and approval of study specification documents (including operational requirements & specifications) and/or key vendor deliverables (including translations).
o Understands, mediates, and solves issues related to Data acquisition and escalates as appropriate to the Study Data Manager or Vendor.
o Develops the study eDC application and associated documents including forms, data validation checks & data extraction and ensures delivery with quality and on time.
o Provides reports, status updates, feedback, and raises risks and advice to Study Data Manager about study set-up and/or vendor related activities.
o Ensures quality control of deliverables
o Responsible for performing after-action reviews (success or failure) to share learnings and propose improvements for the future.
• Acts as a Subject Matter Expert for core Data Acquisition activities like process improvements, new processes, training, quality assessments, audits and inspections.
• Acts as a mentor in their expertise area to shorten the learning curve of the more junior profiles and act as a reference model within the Data Acquisition team. AND Responsible for building capability, leading, and mentoring junior team members.
• As required, may have line management responsibilities for a small team.Adhere to the relevant departmental SOPs, corporate policies, regulatory requirements and industry best practices.
• When studies are outsourced either through an e2e DM FSP model or through FSO, supports the Study Data Manager & Oversight Data Manager in specific ePRO, eCOA, and other external vendor data matters or issues.
Minimum Level of Job-Related Experience Required
•10+ years of experience in data acquisition or related job experience in Clinical Research or Information Systems and/or relevant scientific experience.
•2+ Project Management and/or People management experience with direct/indirect reporting is preferred.
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 IN.recruitment-adjustments@gsk.com to discuss your needs.
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