The Study Delivery Associate (SDA) works in collaboration with the Project Delivery Lead (PDL) and Study Delivery Lead (SDL), providing operational and administrative support for project and study delivery activities in adherence to GCP-ICH guidelines, GSK control documents; as well as support for the overall management of project/study timelines/budget. The SDA will support one or several projects and associated studies as per the workload requirements and reports to a Manager Study Delivery. The SDL and PDL will remain accountable at study and project level respectively.
1. Systems data accuracy:
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, Data Accuracy 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
2. Support for budget:
Coordinate Study Budget Breakdown (SBB) process and track SBB status from start to en(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
3. Support for contract:
Provide support on contract development (Intercompany Clinical Trial Agreements (ICTAs), Services Agreements…) as appropriate
4. Support for quality:
Provide timely support to SDL and study team for TMF cleanliness and completeness, as needed. Support SDL/PDL for quality assessments/controls and inspections/audits as needed.
5. Support for operational activities:
Support the SDL/PDL for study and project coordination (e.g. providing the team with study related reports, actions follow up, etc.), as appropriate
Provide support for preparation and/or customization of the templates of study documents (viaeTMF) according to study requirements
Creation/review 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 October , 2015 Page 2 of 3
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
7. Appointment scheduling for study and project related meetings
8. Support process improvement initiatives and shares best practices and lessons learned within study delivery and beyond
BS Degree and 2 plus years of relevant experience in pharmaceutical / scientific environment
Familiarity with basic finance and accounting principles in order to understand budget, invoices, cross charges and expense reports
Familiar with GCP-ICH guidelines
Proficiency in Microsoft office (Excel, PowerPoint, Word, Outlook, MS Project)
Advanced Excel, MS project, eTrack, Documentum and SAP
Scientific background and knowledge of clinical trials (including ICHGCP)
Project Management Experience
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