Solomon Page
We are seeking a Clinical Trial Manager to oversee clinical trial operations, ensuring projects meet quality standards, regulatory compliance, and timeline requirements. This role requires exceptional vendor and Contract Research Organization (CRO) management capabilities and direct accountability for study outcomes. The position involves collaborative work across single or multiple trials to advance clinical operations objectives.
Responsibilities:
Trial Management & Operations
Lead daily operations for assigned clinical trials throughout all study phases to achieve established deliverables Execute studies according to project team goals and objectives while maintaining quality standards Monitor clinical data for timely entry and preparation for data review sessions Conduct periodic clinical data reviews and assess monitoring reports for completion and issue identification Maintain comprehensive trial metrics and performance indicators Communication & Coordination
Provide regular updates to internal stakeholders regarding project deliverables and progress Collaborate with Project Management to align study timelines with critical milestones Escalate potential timeline risks and deliverable challenges proactively Develop and sustain collaborative relationships with key stakeholders Risk Management & Quality Assurance
Identify potential study risks and develop comprehensive mitigation strategies Ensure adherence to FDA and ICH/GCP guidelines across all trial activities Maintain compliance standards for multi-regional global trials Coordinate trial sample preparation and vendor delivery to meet study requirements Team Leadership & Vendor Management
Provide oversight and guidance to study team members and external vendors Manage trial feasibility assessments and site selection processes Establish and implement effective investigator and site monitor training programs Collaborate closely with Clinical Operations Leads on study execution Documentation & Systems
Contribute to the development and review of clinical trial documentation including protocols, informed consent forms, and site materials Create training manuals and support documentation as needed Support user acceptance testing (UAT) for clinical trial systems and databases Required Qualifications:
Experience
Minimum 5-10 years of clinical trial coordination experience in clinical research environments Required: Oncology or Neurology therapeutic area experience Demonstrated ability to manage multiple concurrent projects effectively Global experience managing CROs and multiple study vendors Comprehensive understanding of drug development processes Preferred Experience
Clinical pharmacology healthy volunteer studies experience Trial Master File implementation experience Skills & Knowledge
Strong project management capabilities Thorough understanding of FDA and ICH GCP guidelines Excellent communication and stakeholder management skills Risk assessment and mitigation planning abilities Education
Bachelor's degree in clinical or science-related field required Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn .
Opportunity Awaits. #LI-SS11
Responsibilities:
Trial Management & Operations
Lead daily operations for assigned clinical trials throughout all study phases to achieve established deliverables Execute studies according to project team goals and objectives while maintaining quality standards Monitor clinical data for timely entry and preparation for data review sessions Conduct periodic clinical data reviews and assess monitoring reports for completion and issue identification Maintain comprehensive trial metrics and performance indicators Communication & Coordination
Provide regular updates to internal stakeholders regarding project deliverables and progress Collaborate with Project Management to align study timelines with critical milestones Escalate potential timeline risks and deliverable challenges proactively Develop and sustain collaborative relationships with key stakeholders Risk Management & Quality Assurance
Identify potential study risks and develop comprehensive mitigation strategies Ensure adherence to FDA and ICH/GCP guidelines across all trial activities Maintain compliance standards for multi-regional global trials Coordinate trial sample preparation and vendor delivery to meet study requirements Team Leadership & Vendor Management
Provide oversight and guidance to study team members and external vendors Manage trial feasibility assessments and site selection processes Establish and implement effective investigator and site monitor training programs Collaborate closely with Clinical Operations Leads on study execution Documentation & Systems
Contribute to the development and review of clinical trial documentation including protocols, informed consent forms, and site materials Create training manuals and support documentation as needed Support user acceptance testing (UAT) for clinical trial systems and databases Required Qualifications:
Experience
Minimum 5-10 years of clinical trial coordination experience in clinical research environments Required: Oncology or Neurology therapeutic area experience Demonstrated ability to manage multiple concurrent projects effectively Global experience managing CROs and multiple study vendors Comprehensive understanding of drug development processes Preferred Experience
Clinical pharmacology healthy volunteer studies experience Trial Master File implementation experience Skills & Knowledge
Strong project management capabilities Thorough understanding of FDA and ICH GCP guidelines Excellent communication and stakeholder management skills Risk assessment and mitigation planning abilities Education
Bachelor's degree in clinical or science-related field required Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn .
Opportunity Awaits. #LI-SS11