US-NJ, Clinical Study Manager (CSM) Group Head 220425BR-MZ
Clinical Study Manager (CSM) Group Head
Global Drug Development
East Hanover, NJ
Research & Development
The Clinical Study Manager (CSM) Group Head is responsible for the CSMs and their study specific activities, including the hiring, training, development and assignment of CSMs to ensure qualified study management. The CSM Group Head assures that CSMs coordinate their activities across all CRAs working on the same trials/projects in collaboration with the CRA Managers.
The CSM Group Head is responsible for CSM (Trial Monitoring and external) compliance of study management activities and for the delivery of study milestones, in close collaboration with the CRA Mangers and aligned with Global and local medical strategy, in the country. The CSM Group Head is responsible for CSM performance (KPIs), ensuring the study milestone deliverables, in accordance with GCP, ICH, SOP s, and local regulations.
Trial Monitoring strategy
Collaborates with Trial Monitoring Country Head, Cluster/Region Head, Development Unit Head and CRA Managers to implement country innovative practices and patient engagement tactics (as appropriate) to advance clinical trial planning, execution and quality in line with Trial Monitoring country leadership
Identifies and leads innovative solutions to further advance the Project Management in GDD portfolio, in collaboration with Trial Monitoring country leadership
Allocation, initiation and conduct of trials
Develops opportunities in collaboration the CRA Manager, Regional Operations Manager (ROM) and Country medical to build a competitive advantage for GDD trials within the Country by directing CSMs to follow the local medical standard of care, local business drivers and site relationship management
Operationally allocates new trials in collaboration with Trial Monitoring Country leadership, during trial feasibility/allocation
Ensures Country study site selection, activation, enrolment, data flow and timeline commitments are delivered and reported per established study milestones and Country commitments
Collaborates with local medical/clinical teams to enhance Novartis relationship with clinical sites, to ensure optimal site relationship management to deliver on study commitments
Delivery of quality data and compliance to quality standards
Is accountable for timely issue identification, escalation and resolution to ensure study management deliverables are on track
Collaborates with Clinical Research Associate (CRA) Manager to ensure that monitoring trends that require targeted training and/or development are escalated.
Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
Manages CSM adherence/compliance to SOPs and required training curricula
Ensures CSM competency gaps are identified and resolved through targeted training curricula in collaboration with local training and Trial Monitoring
Supports CPO / site audits and inspections (as appropriate) related to CAPA follow-up and implementation of study level identified issues
Management of people and resources management
Is responsible for the hiring, training, development and retention of a team of Clinical Study Managers (CSMs) to ensure study milestones are delivered for the Innovative Medicines Phase I-IV Global Drug Development (GDD) trials
Performs ongoing assessment and allocation of Clinical Study Manager resources within Country, Cluster or Development Unit to ensure balanced CSM workload
Ensures Clinical Study Managers have the required level of project management and Development Unit (disease) area knowledge and skills to successfully deliver study and protocol requirements
Is responsible for managing and addressing CSM performance targets per defined Trial Monitoring key trial milestones (including country trial commitment), and serves as an escalation of study issue resolution in collaboration with the CRA Managers and their CRAs
Budget and productivity
Ensures country study budgets (Trial Commitment Forms, TCFs) are managed per established study key performance indicators and study objectives
Ensures study milestones to allow timely payments to stakeholders (invoice able items and vendors) for clinical trial activities
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
A degree in scientific or health discipline required and advanced degree with experience in project management, is preferable
Minimum 8 years experience in clinical research and/or project management and evidence of team management and leadership capabilities; 4 years of people management experience
Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
Excellent project management capabilities with demonstrated capability to problem solving and mediate complex compliance issues
Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
Communicate effectively in a local/global matrixed environment
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