Study Startup Manager

Summary

-Oversees the execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements. Monitors adherence to protocols and determines study completion. Manages clinical and regulatory files and maintains clinical inventory intended for distribution to investigational sites. May interact with investigational sites, clinical consultants, Contract Research Organizations and other vendors. Selects, develops and evaluates personnel to ensure the efficient operation of the function.

About the Role

Major accountabilities:

• Oversees clinical program(s) across indications, executing medical strategy for development and marketed products in a defined therapeutic area.
• Conduct study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
• Is responsible for assuring aligned communication with Country/Cluster Clinical Research Associates, Managers and other key stakeholders on the execution and progress of the clinical studies.
• Identify new sites for clinical trials; analyze capability and make recommenda-tion for trial inclusion.
• Facilitate preparation and collection of site level documents; resolve problems as required.
• May execute site initiation and training.
• Implement total site management including monitoring visits, regulatory assess-ment, drug supply management and resolution of site problems to ensure compli-ance.
• Track trial execution milestones; identify problems; resolve issues and escalate as appropriate.
• May manage recruitment and execute contingency plans, as needed.
• Complete preparation/generation of study monitoring reports.
• May lead and chair local study team meetings, attend and participate in global clinical trial team meetings -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Deliver customer satisfaction results for internal and external customers -Delivery of Clinical Trials to quality standards and agreed timelines -Adherence to Novartis policy and guidelines and external regulations.

Minimum Requirements: Work Experience:

• Managing Crises.
• Collaborating across boundaries.
• Functional Breadth.

Skills:

• NA.

Languages :

• English.

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