YOUR KEY RESPONSIBILITIES:
- Lead all aspects of global clinical trials to deliver study outcomes within schedule, budget, quality/compliance and performance standards.
- Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality /compliance and performance standards.
- Conduct study start-up activities such as being responsible for protocol development, CRF development, Informed Consent Form development.
- May identify new sites for clinical trials; analyze capability and make recommendation for trial inclusion.
- Ensuring accurate handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
- Responsible for education, implementation and compliance to standards (SOPs) and best practices for clinical operations within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
- Responsible for clinical execution and management of assigned clinical studies (interventional and non-interventional, from early phase to late phase) and other clinical services (e.g. managed access programs (MAP), Research Collaborations etc.) executed by NBS CONEXTS on behalf of Novartis Organizations.
WHAT YOU’LL BRING TO THE ROLE:
- Core member of the Clinical Trial Team, Contributes to operational excellence through process improvement and knowledge sharing
- Bachelor’s Degree or above, English proficiency
- At least 3-10 years’ of Clinical Operations experience with managerial experience in planning, executing, reporting and publishing Global clinical studies in a pharmaceutical company or contract research organization.
- Clinical Research Phases Clinical Trial Set-up, Management & Conduct Relevant educational background in life sciences/Healthcare
- Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.
- Working in multi-national context and across countries
- Strong customer orientation; Experience in working with different cultures, team located worldwide and cross-functionally; Demonstrated presentation and tact skills. Negotiation and conflict resolution skills.
- Proven track record to work independently in a sophisticated matrix environment (including remote).