Talent Groups · 20 hours ago
Clinical Operations Manager
Waltham, MA
Contract
Hybrid
Senior Level, Lead/Staff
10+ years expTalent Groups is a company focused on clinical operations, and they are seeking a Clinical Operations Manager with extensive experience in the biotechnology or pharmaceutical industry. The role involves improving operational efficiency, ensuring compliance with regulations, and leading clinical trials.
IT Management
Hiring Manager
Pravalika Kodupuganti
Responsibilities
Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required
Experience leading global trials outside the US/UE/ASIA/Americas is preferred
Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management
Demonstrated experience in successful planning and implementation of clinical trial operations
Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
Qualification
Required
M.S or Ph.D in basic sciences with 10+ years' experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO
Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required
Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management
Demonstrated experience in successful planning and implementation of clinical trial operations
Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
Preferred
Experience leading global trials outside the US/UE/ASIA/Americas
Company
Talent Groups
Talent Groups delivers exceptional experiences by solving the toughest IT talent and technology challenges across all industries.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2018-07-01Acquired
Leadership Team
Matthew James Ripaldi
Chief Executive Officer
Recent News
2024-05-20
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