You are currently viewing GSK job opening for Senior Study Delivery Specialist- apply now

GSK job opening for Senior Study Delivery Specialist- apply now

GSK job opening for Senior Study Delivery Specialist- apply now

Job description

Site Name: Bengaluru Luxor North Tower
Posted Date: May 5 2023
Job Purpose:
Study Manager (SM) is responsible for end-to-end operational study delivery, including development and review of
study documents, completion and maintenance of internal systems/databases/tracking tools and project plans,
vendor management, cooperation with Local Operating Companies (LOCs) and other internal functions.
 SM executes trial management activities, as delegated by Study Delivery Lead (SDL) for in-house and outsourced studies across all phases and therapy areas, in accordance with standard operating procedures, clinical operational
plans, regulatory requirements and Good Clinical Practice
 Working in close partnership with SDL, SM plays a key role in successful study delivery, providing subject matter expertise across key processes and systems through the life cycle of the study. SDMs should be able to apply their judgement and take a risk-based approach to make independent decisions with minimal guidance from SDL.
 SDM role is implemented to have a broader impact on the business, by driving continuous improvement initiatives.
within their remit of expertise, sharing best practices across the business, with a focus on increasing efficiency of
operational delivery of studies.

Key Responsibilities:
Delivery of study to plan, including managing the study team’s communication/meetings, tracking progress and the
monitoring/assessment of risks to timeliness or quality of study delivery
• Preparation and update of study documents and study plans (incl CSAP), including study protocol, Monitoring Plans,
Vendor Management Plans, Protocol Deviation Management Plans, Risk Management Plans, Communication Plans
• Local Operating Companies liaison / oversight – including tracking of recruitment progress, data completeness and
compliance, local budget oversight, protocol deviations oversight, supplies’ availability, regulatory approvals and
import license status.
• Vendor management & CRO oversight – agreeing on study-specific setup requirements, ensuring continued
monitoring of agreed delegated activities.
• Supporting SDL in quality and data oversight to ensure inspection/audit readiness, including oversight of eTMF
• Setting up and maintaining clinical trial management systems and tracking tools that ensure quality, consistency and
integration of study data, following up on discrepancies if needed.
• Risk management – contribution to maintenance of a comprehensive risk management plan and risk tracking
• Clinical supplies and recruitment materials management – having oversight on study level supplies availability,
recognizing and communicating issues to continuity of supplies, proposing solutions as appropriate
• Coordination of the study budget – including support to contract management for vendors, managing expenses,
tracking updates, checking consistency between systems and agreements and escalating issues
• Providing input to develop study specific processes and procedures, adhering to standardization and dissemination
of best practices
• Providing support to departmental initiatives and objectives, including for example support, training/mentoring as



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