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Job Details


GlaxoSmithKline (GSK)

Study Delivery Specialist (330096)

Pharmaceuticals

All

Yearly

No

Warsaw, Indiana, United States

Site Name: Warsaw
Posted Date: May 5 2022

We are looking for Study Delivery Specialists (SDS) to join us. As the SDS, you will work in collaboration with the Study Delivery Lead (SDL) to provide end to end operational and administrative support for study delivery activities. You will be responsible to perform activities for one or several projects, and you will have to ability to support most types of studies (different therapeutic areas, pivotal/critical path, Phase III, efficacy studies just to name a few). You will be the primary point of contact for TMF matters and you will work closely with the Study Accountable Person.

Key responsibilities:

  • Responsible for supporting the SDL in study management activities, for all type of studies all phases, pivotal, critical path and complex studies.
  • Participating as a Subject Matter Expert (SME) in meetings and initiatives to update the processes and GSK systems and providing training to the SDS team and/or external partners in area of responsibility

Systems data accuracy:

  • Ensure accurate completion and maintenance of internal systems, databases, tracking tools and study plans and high quality, consistent and up-to-date information in planning and tracking tools for study level data
  • Under the direction of the SDL, assist in preparing study report and status, assist in compiling data in preparation of study presentations and updates related to time/budget/quality
  • Follow-up with study team members (SDL, local country staff, etc.) to resolve discrepancies as needed and escalate any issue to SDL
  • Follow up on country and centre level activities that need to be performed in systems

Support for budget:

  • Coordinate the Study budget process and track budget status from set-up to end (approval), including encoding the budget in the relevant systems and ensure consistency between systems and agreements/contracts
  • Review Budget Actuals vs. Forecasts, monitor expenses (invoices and cross-charges) on regular basis and support to answer finance questions and any cost management plan maintenance
  • Provide support in resolution of deviations/issues in actual expenses and escalate if required to SDL

Support for contract:

  • Provide support on contract development (Intercompany Clinical Trial Agreements (ICTAs), Service Agreements, etc.) as appropriate
  • For contract with vendor(s) for which ClinOps is the Business Owner, create the PO and provide PO number

Support for quality:

  • Support SDL for quality assessment/control activities to ensure inspection/audit readiness

Support for operational activities:

  • Support the SDL for study coordination (e.g. providing the team with study-related reports, maintaining team sites, follow up on actions, etc.), as appropriate
  • Provide input and help to develop/assist study specific processes and procedures, adhering to standardization and dissemination of best practices
  • Provide support for the preparation of study and operational meetings (e.g. MM, IM)
  • Participate in study specific meetings (including scheduling meetings, meeting minutes preparation and dissemination, follow-up with team members)
  • Provide support for preparation and/or customization of the study plans (Monitoring Plans, Recruitment Plans, Study Newsletters etc.) and templates of study documents (via TMF or appropriate system) according to study requirements
  • Provide support to ensure documents needed for submission are available (TMF or appropriate system) for the country and follow up on the completion of site level documents
  • Assist the SDL in monitoring study conduct and progress, identifying and resolving risks/ issues which may impact delivery of the study to the necessary quality, timeline or budget objectives
  • Review and analyze the Key Risk Indicators (KRIs) and monitoring metrics, follow up on actions and escalate issues as appropriate
  • Support process improvements, share best practices, lessons learnt and implementation of improvements within the team and beyond
  • Support study related logistics, resolve complex requests, recognize underlying issues, and communicate issues and proposed solutions as appropriate
  • Liaise with external vendors (FSO partners) on specific study level activities, ensuring continued monitoring of agreed delegated activities

Support for TMF Management:

  • Leads planning and executing of TMF management related activities of the clinical study, from study start-up till archiving, in order to ensure that the TMF is of high quality and updated in a timely manner to ensure inspection readiness
  • Monitors and identifies trends for a study/project they support.
  • Generates and analyses TMF metrics at study and project level (completeness and quality) to track performance and takes the appropriate actions to address gaps, issues and risks.
  • Provides TMF management expertise to Study Accountable Person (SAP) and their study team members globally as needed (e.g. instream quality check of trial master file data, drafting and preparation of documents etc.) to support their study deliverable targets, to agreed quality and data integrity standards.
  • Participates in study team meetings and provides/presents study TMF status and performance updates, escalate concerns and highlights risks.
  • When working with third party providers, contributes to the TMF set-up, development of TMF oversight plan and the coordination of the transfer of study-specific trial master files from the CRO
  • Develop and maintain the study TMF management plan and ensures adherence by the study team
  • Understand all technical aspects of TMF system and associated tools.

Basic Qualifications:

  • Bachelor's degree in life sciences or other related field
  • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
  • Ability to manage multiple competing priorities within various clinical trials with good planning, time management and prioritization skills
  • Quality mindset, critical sense, attention to details. Promotes a total quality culture
  • Good understanding of the principles of project planning & project management
  • Proven negotiation and influencing skills and effective at conflict resolution
  • Familiarity with basic finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports
  • Tools knowledge like Microsoft office (Excel, PowerPoint, Word, Outlook, etc.)

Preferred Qualifications:

  • Knowledge of Advanced Excel, timelines/budget tracking system or clinical trial management system are an asset
  • Able to think independently, analyse and solve problems systematically and creatively and able to take a risk-based approach
  • Logical/ Analytical and an inclination to spot patterns and outliers
  • Good communication skills (oral & written) and interpersonal skills
  • Stress resistant
  • Results driven and efficient
  • Motivated and dynamic personality
  • Able to evolve in a changing and challenging environment
  • Team spirit and ability to work across cultures and geographies with a high awareness and understanding of cultural differences

*LI-GSK

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