Job Description Summary
Primary contact for FSP and other monitoring services (vendors) to assure adequate quality of the services & performance in Novartis sponsored clinical trials. Oversees vendor monitoring performance targets per defined quality performance indicators, including site recruitment commitments, timely data entry and issue resolution KPIs. Aligns with FSP and other vendor’s managers on CRA and other vendor resource related allocation to trials and studies. Requires strong communication skills and ability to influence internal and external stakeholders in order to maximize quality and efficiency of external service providers.
Job Description
Key Responsibilities:
- Develop country resource needs/expectations strategy and align with vendor line management (CRAs and other vendor resources). Establish governance model.
- Promote a compliance culture advocating the adherence to the highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
- Escalate non-compliance, performance issues, competency gaps and/or needs to vendors.
- Oversee country trial site activation, enrolment, data flow and timeline commitments are delivered per established trial objectives.
- Oversee monitoring quality, timely data entry and issue resolution including oversight of CRA oversight visit performance.
- Support Clinical Development Audit and FSP vendors for site audits and inspection.
- In collaboration with SSO Clinical Project Manager (CPM), support recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities.
- Ensure country FSP strategy is aligned with global and hub plans.
Essential Requirements:
- Minimum 7 years’ experience in clinical research - planning/executing and/or monitoring clinical trials.
- Experience and evidence of team leadership capabilities.
- Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution.
- Demonstrated negotiation and conflict resolution skills.
- Fast change adaptability to best partner & influencing with FSP vendor on fast changing landscape.
- Trust and rapport building is a very important skill needed.
- Good communication skills, ability to influence others & relationship management.
- Excellent communicator and presenter (oral and written).
- Good analytical thinking.
Skills Desired:
Budget Management, Clinical Research, Clinical Study Reports, Clinical Trials, Clinical Trials Monitoring, Communication, Data Analysis, Decision Making, Health Sciences, Life Science, People Management, Regulatory Compliance.
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