Medical Operations Manager
hace 1 semana
The Novartis Clinical Project Manager plays a crucial role in ensuring the successful execution of global drug development studies in assigned geographies. This individual will be responsible for planning, executing, and reporting on studies from initiation to close-out, adhering to Novartis processes and regulatory requirements.
Key Responsibilities:
- SUPPORTS SSO Study Start-up Manager in developing country/cluster/hub study execution plans and timeline commitments
- PARTICIPATES IN THE RECRUITMENT SUB-TEAM AND SUPPORTS DEVELOPING INNOVATIVE SOLUTIONS FOR SITE AND PATIENT PARTICIPATION TO ENSURE DELIVERY OF ASSIGNED STUDIES ON TIME
- PROACTIVELY IDENTIFIES RISK AND OPPORTUNITIES FOR THE ASSIGNED STUDIES WITHIN THE COUNTRY/CLUSTER/HUB AND DEVELOPS RESPECTIVE MITIGATION PLANS
- INITIATION AND CONDUCT OF TRIALS
- OVERSEES LOCAL STUDY TEAM ACTIVITIES TO ACHIEVE STUDY TIMELINES AND QUALITY EXECUTION, (PROPOSING AND IMPLEMENTING CORRECTIVE ACTIONS WHERE APPROPRIATE), ACCORDING TO NOVARTIS STANDARDS AND RELEVANT REGULATIONS
- COORDINATES THE STUDY HANDOVER PROCESS WITH CRAs AND THEIR MANAGERS TO ENSURE PROPER DOCUMENTATION AND COMMUNICATION, WHEN NECESSARY
Deliver Quality Data and Compliance to Quality Standards:
- CONDUCTS OR COORDINATES TRAINING, AS NEEDED, FOR CRAs TO SUPPORT SITE READINESS TO RECRUIT AND STUDY EXECUTION ENSURING ADHERENCE TO CLINICAL DATA STANDARDS, PREVAILING LEGISLATION, GCP, ETHICAL COMMITTEE AND SOP REQUIREMENTS
- EVALUATES POTENTIAL CHALLENGES/RISKS WITHIN THE PROTOCOL AND OPERATIONAL ASPECTS OF THE STUDY; ASSESSING IMPACTS, DEVELOPS RISK MANAGEMENT PLANS AND COMMUNICATES/ ESCALATES TO GLOBAL TEAMS AND SSO HUB HEAD PORTFOLIO, AS APPROPRIATE
- AFFILIATED SALARY: $85,000 - $110,000 Annually
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