Clinical Operations Specialist
- College degree or equivalent experience
- Familiarity with medical terminology/clinical study design and budgets would be an asset
- Good financial acumen and understanding of financial processes
- Working knowledge of documentation management practices with good understanding of GCP and regulatory requirements for document retention
- Good understanding of Clinical development processes to implement improvements to resolve issues
- Proficiency in clinical systems – e-track, financial forecast model, validated filing repositories; ability to master new systems due to ongoing changes/upgrades
- Self-motivated with ability to work, solve problems and make decisions unsupervised.
- Good communication and organizational skills with ability to interact well with all levels of management and staff (internal and external).
- Able to plan, organize and manage priorities.
- Accountability for own actions/decisions
- Able to work independently as well as in a team.
- Recognizes potential obstacles and works to resolve them within set timelines, takes responsibility for own actions
- Conscientious and high quality delivery of work even when under pressure
- Effective at technical problem solving
- Professional attitude with good customer focus (internal and external)
- Flexible and responsive to new ideas in a changing environment
- Proficient in use of SAP
- Degree preferred
- Advanced Excel skills (e.g. macros, v-lookup)
- Pharmaceutical industry experience
- Local HCP/HCO vendor creation and management in SAP
- PO/cost centre set up and tracking
- Tracking and managing budget once study budget is built by the Local Study Managers. Generates reports to address queries from clinical trial sites, local study team and Clinical Operations Managers. Ensures compliance to financial SOPs and demonstrates integrity of investigator payment finances during internal/external audit.
- Associating the Canadian Subject Visit Template (SVT) it to all Canadian centres and inputs accurate information to financial systems – in e-Track, financial forecasting models, SAP.
- Processing all payments for studies including invoices and updating all required trackers. Investigates all financial reporting discrepancies (e.g. SAP).
- Develop and implement reporting and tracking tools (e.g. Excel)
- • Forecast site/study payments utilizing forecasting model and report budget/spend status at center and study levels to internal stakeholders (local study managers, directors/managers, global study teams, finance). Works collaboratively with the local study team to ensure accurate and timely payment of vendors.
- Files and archives clinical development documents in validated repositories according to SOPs and local regulations. Acts as liaison between GSK and external archiving facility for the archiving and retrieval of paper documents.
- Accountable as custodian for shared area drives ensuring access rights and use of, comply with local and/or global policies and procedures.
- Distributes Safety reports on behalf of the Medical Division as required to study sites and associated vendors when required and logs, tracks and files supporting documentation for audit.
- Trains Clinical Development Department staff on new processes relating to clinical finance, safety report distribution, and or filing and archiving.
- Ensures all activities are in compliance with GSK SOPs, reports any deviations to senior management and implements corrective actions
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]
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