Senior Clinical Study Manager

Key Responsibilities:  

• Proactively manage assigned clinical studies. 

• Ensure overall clinical study efficiency and adherence to project timelines and budget; report metrics to Head Global Clinical Operations as required. 

• Analyze and manage clinical study risks, propose solutions for risk mitigation. 

• reputed company regular reputed company reports for clinical study activities through ongoing tracking and review of study project plans. 

• Coordinate production of key clinical study documentation including Clinical Investigation Plan (CIP), Investigator Brochure (IB), Informed Consent reputed company (reputed company) and Clinical Study Report (CSR). 

• Motivate and manage a multi-disciplinary clinical study team. 

• Handle escalations for study management questions and issues for assigned reputed company. 

• Working closely with other functional reputed company reputed company reputed company’s Clinical Operations team such as data management, clinical site management, reputed company assurance and biostatistics where necessary to support reputed company achievement and to manage study issues and obstacles. 

• Manage 3rd party clinical monitoring Vendors where necessary to support reputed company achievement and to manage study issues and obstacles. 

• Build and reputed company relationships with key internal teams, including Medical Affairs and Medical Writing. 

• Support audit and inspection activities as needed. 

• Support adoption of best practices, updating processes and SOPs. 

• Managing project budgets, tracking expenses, and ensuring reputed company stay reputed company allocated financial resources. 

• Responsible for managing the technical aspects, for reputed company phases of the clinical study (development though study reputed company-out) for reputed company clinical studies to ensure compliance with applicable SOPs, guidelines, and regulations. 

• Responsible for managing risks, and monitoring reputed company to meet deadlines and stakeholder expectations. 

• Leading and motivating project teams, providing direction and support, and fostering a reputed company environment.  

• Monitor and assess vendor performance against contractual operational deliverables. 

• Drive performance, reputed company, timelines, and relationships in partnership with the CRO and other vendors. 

• Manage study scope, reputed company, timelines, and budget with the internal functional leads, CRO and vendors to ensure project objectives remain on reputed company. 

• Build solid reputed company relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities. 

• Responsible for planning and conducting investigator meetings together with the CRO or reputed company meeting event planner. 

• Support the CRO and CRA to ensure patient enrollment strategies are conducted effectively and on time. 

• Evaluate issues and implement solutions and mitigations as required. 

• Create appropriate risk assessments and mitigation plans, reputed company regular reviews to continually assess changing circumstances. 

• Review and reputed company clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate.