Senior Manager, Clinical Trials
Behavioral Health Market Context
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Job Description
er 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Reporting to the Senior Director/Director of Clinical Operations or designee, the Senior Manager, Clinical Trials oversees the planning and execution of clinical studies to ensure compliance with the Investigational Plan, regulatory requirements, and company standards. This role provides clinical and technical expertise in support of Clinical Programs and Marketing Investigations, including on-site support as needed, and may manage and mentor clinical trial staff.
Responsibilities
+ Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: Clinical planning, protocol development, case report form ( CRF ) development, IRB submissions, investigator agreements, informed consent form ( ICF ) development, site selection and communication with senior clinical trial sites regarding all logistics including contract agreements, support materials and training.
+ Provides clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies.
+ Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up, and close out study visits to ensure compliance with protocols and GCP requirements.
+ Collaborates on clinical data processing in accordance w
Reporting to the Senior Director/Director of Clinical Operations or designee, the Senior Manager, Clinical Trials oversees the planning and execution of clinical studies to ensure compliance with the Investigational Plan, regulatory requirements, and company standards. This role provides clinical and technical expertise in support of Clinical Programs and Marketing Investigations, including on-site support as needed, and may manage and mentor clinical trial staff.
Responsibilities
+ Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: Clinical planning, protocol development, case report form ( CRF ) development, IRB submissions, investigator agreements, informed consent form ( ICF ) development, site selection and communication with senior clinical trial sites regarding all logistics including contract agreements, support materials and training.
+ Provides clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies.
+ Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up, and close out study visits to ensure compliance with protocols and GCP requirements.
+ Collaborates on clinical data processing in accordance w
Qualifications
Benefits
Responsibilities
- •Reporting to the Senior Director/Director of Clinical Operations or designee, the Senior Manager, Clinical Trials oversees the planning and execution of clinical studies to ensure compliance with the Investigational Plan, regulatory requirements, and company standards
- •This role provides clinical and technical expertise in support of Clinical Programs and Marketing Investigations, including on-site support as needed, and may manage and mentor clinical trial staff
- •Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: Clinical planning, protocol development, case report form ( CRF ) development, IRB submissions, investigator agreements, informed consent form ( ICF ) development, site selection and communication with senior clinical trial sites regarding all logistics including contract agreements, support materials and training
- •Provides clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies
- •Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up, and close out study visits to ensure compliance with protocols and GCP requirements
- •Collaborates on clinical data processing in accordance w
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