Global Clinical Trials Operations Manager
Behavioral Health Market Context
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Job Description
izations to ensure seamless trial activities.
• Prepare comprehensive study documents including the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual.
• Coordinate and design critical study materials such as CRFs, patient diaries, study participation cards, and source documents.
• Contribute to protocol development and assist in the completion of study reports.
• Oversee monitoring activities at clinical study sites, ensuring adherence to Good Clinical Practices (GCPs), SOPs, and study protocols.
• Provide leadership and guidance to Clinical Research Associates (CRAs).
• Track patient enrollment and manage activities related to site initiation, monitoring, closeout, and data management.
• Coordinate study supply logistics to ensure trial needs are met.
• Negotiate contracts with clinical trial services vendors to support study execution.
• Review Informed Consent Forms, CRFs, and all study-related materials for compliance.
• Plan and actively participate in investigator meetings to align objectives and expectations.
• Assist with the data query process to ensure data integrity and completeness.
• Ensure regulatory compliance for investigational sites in accordance with company SOPs and applicable FDA and ICH guidelines.
• Maintain and update the trial master file consistently throughout the trial lifecycle.
Collaborative Relationships
• Work collaboratively with external vendors and contract research organizations to facilitate efficient trial execution.
Skills
• Oversee all trial aspects from initiation to closeout, ensuring timely completion within budget through effective project management.
• Proactively identify and resolve issues during trial execution to minimize disruptions and maintain study integrity.
• Effectively manage multiple tasks and deadlines within a dynamic clinical trial environment.
• Clearly communicate expectations and information to cross-functional teams, investigators, and stakeholders.
Knowledge and Experience
• A minimum of 5 years of direct experience managing global clinical trials from start to finish in a CRO or pharmaceutical setting.
• Thorough understanding of Good Clinical Practices (GCPs) and regulatory compliance, including FDA and ICH guidelines.
• Experience with clinical trial documentation processes such as protocols and monitoring plans.
• Proficient in data management and query resolution in clinical trials.
• Comprehensive knowledge of site management and monitoring procedures.
Education
• Bachelor's Degree in the life sciences field is required.
#LI-CF1
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
• Prepare comprehensive study documents including the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual.
• Coordinate and design critical study materials such as CRFs, patient diaries, study participation cards, and source documents.
• Contribute to protocol development and assist in the completion of study reports.
• Oversee monitoring activities at clinical study sites, ensuring adherence to Good Clinical Practices (GCPs), SOPs, and study protocols.
• Provide leadership and guidance to Clinical Research Associates (CRAs).
• Track patient enrollment and manage activities related to site initiation, monitoring, closeout, and data management.
• Coordinate study supply logistics to ensure trial needs are met.
• Negotiate contracts with clinical trial services vendors to support study execution.
• Review Informed Consent Forms, CRFs, and all study-related materials for compliance.
• Plan and actively participate in investigator meetings to align objectives and expectations.
• Assist with the data query process to ensure data integrity and completeness.
• Ensure regulatory compliance for investigational sites in accordance with company SOPs and applicable FDA and ICH guidelines.
• Maintain and update the trial master file consistently throughout the trial lifecycle.
Collaborative Relationships
• Work collaboratively with external vendors and contract research organizations to facilitate efficient trial execution.
Skills
• Oversee all trial aspects from initiation to closeout, ensuring timely completion within budget through effective project management.
• Proactively identify and resolve issues during trial execution to minimize disruptions and maintain study integrity.
• Effectively manage multiple tasks and deadlines within a dynamic clinical trial environment.
• Clearly communicate expectations and information to cross-functional teams, investigators, and stakeholders.
Knowledge and Experience
• A minimum of 5 years of direct experience managing global clinical trials from start to finish in a CRO or pharmaceutical setting.
• Thorough understanding of Good Clinical Practices (GCPs) and regulatory compliance, including FDA and ICH guidelines.
• Experience with clinical trial documentation processes such as protocols and monitoring plans.
• Proficient in data management and query resolution in clinical trials.
• Comprehensive knowledge of site management and monitoring procedures.
Education
• Bachelor's Degree in the life sciences field is required.
#LI-CF1
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Qualifications
- •Oversee all trial aspects from initiation to closeout, ensuring timely completion within budget through effective project management
- •A minimum of 5 years of direct experience managing global clinical trials from start to finish in a CRO or pharmaceutical setting
- •Thorough understanding of Good Clinical Practices (GCPs) and regulatory compliance, including FDA and ICH guidelines
- •Experience with clinical trial documentation processes such as protocols and monitoring plans
- •Proficient in data management and query resolution in clinical trials
- •Comprehensive knowledge of site management and monitoring procedures
- •Bachelor's Degree in the life sciences field is required
Benefits
Responsibilities
- •Join our client's Development Operations team as a Global Clinical Trials Operations Manager
- •In this role, you will oversee and enhance the management of clinical trials and programs as part of the Clinical Trial Working Group, ensuring effective execution and compliance throughout the process
- •Lead the management of external vendors and contract research organizations to ensure seamless trial activities
- •Prepare comprehensive study documents including the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual
- •Coordinate and design critical study materials such as CRFs, patient diaries, study participation cards, and source documents
- •Contribute to protocol development and assist in the completion of study reports
- •Oversee monitoring activities at clinical study sites, ensuring adherence to Good Clinical Practices (GCPs), SOPs, and study protocols
- •Provide leadership and guidance to Clinical Research Associates (CRAs)
- •Track patient enrollment and manage activities related to site initiation, monitoring, closeout, and data management
- •Coordinate study supply logistics to ensure trial needs are met
- •Negotiate contracts with clinical trial services vendors to support study execution
- •Review Informed Consent Forms, CRFs, and all study-related materials for compliance
- •Plan and actively participate in investigator meetings to align objectives and expectations
- •Assist with the data query process to ensure data integrity and completeness
- •Ensure regulatory compliance for investigational sites in accordance with company SOPs and applicable FDA and ICH guidelines
- •Maintain and update the trial master file consistently throughout the trial lifecycle
- •Collaborative Relationships
- •Work collaboratively with external vendors and contract research organizations to facilitate efficient trial execution
- •Proactively identify and resolve issues during trial execution to minimize disruptions and maintain study integrity
- •Effectively manage multiple tasks and deadlines within a dynamic clinical trial environment
- •Clearly communicate expectations and information to cross-functional teams, investigators, and stakeholders
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