Study Delivery Specialist vacancy in GSK Bengaluru, Karnataka, India

Searching for a Job at GSK in Bengaluru, Karnataka, India

About the job

Site Name: India – Karnataka – Bengaluru

Posted Date: Jan 14 2022

External

Minimum Experience:

Graduate or Bachelor level with relevant working experience in

pharmaceutical / scientific environment.

Scientific background and knowledge of clinical trials (including ICHGCP)

is an asset.

Experience in project management is an asset.

Finance experience is a plus.

 Systems Data Accuracy

Key Responsibilities:

• Ensure high quality and up-to-date information in planning and tracking tools for project and

study level data (e.g. SAP, eTrack, MicroSoft Project, Planisware, …)

• Ensure consistency of the information for agreed study and project level information between

the Clinical Project Tracking and other relevant databases (e.g. MSP, SAP) using available

reports (e.g. Active Portfolio report, eTrack Compliance report).

• Follow-up with study team members (SDL, Local Delivery Lead (LDL) …) to resolve

discrepancies as needed and escalate any issue to SDL/PDL.

• Under the direction of the SDL/PDL: assist in preparing study/project report and status, assist

in compiling data in preparation of study/project presentations and updates related to

time/budget/quality.

 Support For Budget

• Coordinate Study Budget Breakdown (SBB) process and track SBB status from start to end

(approval), including encoding SBB in SAP and ensure consistency between SBB-SAP and

ICTA.

• Review Budget Actuals vs. Forecasts, monitor expenses (invoices and cross-charges) on

regular basis and support to monthly studies budget review meeting preparation and any cost

management plan maintenance

• Provide support in resolution of deviations/issues in actual expenses and escalate if required

to SDL/PDL.

 Support for contract: Provide support on contract development (Intercompany Clinical Trial

Agreements (ICTAs), Services Agreements…) as appropriate.

 Support for quality: Support SDL and PDL for quality assessment/controls and inspections/audits as

required (including providing support to TMF completeness and quality assessment).

 Support for operational activities

• Support the SDL/PDL for study and project coordination (e.g. providing the team with studyrelated

reports, actions follow up, etc.), as appropriate.

• Provide support for preparation and/or customization of the templates of study documents (via

eTMF) according to study requirements.

• Creationeview of study specific documents and/or listings according to study requirements.
• Provide support to ensure documents needed for submission are available (eTMF or

appropriate system) for the country.

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• Collect central study essential documents and conduct Level 1 QC (as agreed per process)

and keep an overview of local study essential documents (via TCS).

• Provide an overview of the Financial Disclosure activities in collaboration with TCS (when

appropriate) and cascade to study team as appropriate.

• File and archive central study essential documents and provide support (when required) for

filing and archiving of local study essential documents.

• Maintain team sites as relevant (project, study, RCA,…)
• Provide support for the preparation of operational meetings (e.g. Monitors meetings) as

appropriate.

• Participate in study specific meetings (including meeting minutes, preparation, dissemination,

follow-up to/with team members and archiving)

• Support process improvements.
• Interact with other team members to share best practices, lessons learned and implementation

of improvements.

 Appointment scheduling for study related meetings.

 Support process improvement initiatives and shares best practices and lessons learned within study

delivery and beyond.

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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Company: GSK

Vacancy Type: Full-time 

Job Location: Bengaluru, Karnataka, India

Application Deadline: N/A

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