Ref #: 38208
Employment type: Permanent - Full-Time
Location: Home-Based UK
Posted: 13-Jun-2022
Description
Detailed Description;
The Senior Global Study Manager is responsible for leading the operational activities to support and enable the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required.
Typical Accountabilities
• Provides operational expertise to the study team.
• Lead the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
• Create team culture and promotes team spirit within the GSMs and GSAs assigned to the study team.
• Provide mentoring and guidance to the operations team ensuring effective collaboration and communication with the study team.
• Manage the set-up of third-party vendors, assessing initial statement of work and budget, as well as the change order process.
• Provide input to data management documents (e.g. Case Report Form, Data Validation Specification), and interface with data management representatives and sites to facilitate the delivery of study data.
• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
• Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
• Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
• Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
• Oversee the clinical trial insurance process; track approvals, revisions and renewals of certificates.
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
• Drive risk management and quality efforts to ensure study compliance.
• Manage set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
• Prepare presentation material for meetings, newsletters and websites.
• Direct the study team in the implementation of audits and regulatory inspections.
• Identify areas of best practice / process improvements and knowledge share across the group.
• Contribute to review of new/amended/unique SOPs and guidance documents.
Education, Qualifications, Skills and Experience
Essential
• University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
• Deep understanding of the drug development process with minimum of 5 years clinical trial experience, of which at least 2 years are in global study management
• Experience of working with and delivering through strategic partners and 3rd party vendors
• Excellent knowledge of ICH-GCP principles
• Team orientated
• Ability to lead, coordinate and prioritise multiple tasks and deliverables
• Proactive approach
• High degree of flexibility
• Demonstrated verbal and written communication skills
• Good negotiation and collaboration skills
• Demonstrated interpersonal and problem-solving skills
• Ability to manage change and actively seek and champion more efficient and effective ways of working
• Ability to coach & act as a buddy for more junior colleagues
• Some travel may be required
Desirable
• Early phase oncology clinical trial experience
Key Relationships to reach solutions
Reports to: Group Director Study Operations
Other key internal relationships:
Study Leader - Early Oncology Clinical
Study Operations
Site Management and Monitoring
Early Clinical Data Management and Biometrics
Clinical Sample and Bioanalytical Science
Regulatory and Patient Safety
Supply Chain
Quality, Training and Risk Management
External Service Providers
Third Party Vendors
Investigators and Site Staff
Please apply today to discuss more details over an informal telephone at your convenience.
The Senior Global Study Manager is responsible for leading the operational activities to support and enable the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required.
Typical Accountabilities
• Provides operational expertise to the study team.
• Lead the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
• Create team culture and promotes team spirit within the GSMs and GSAs assigned to the study team.
• Provide mentoring and guidance to the operations team ensuring effective collaboration and communication with the study team.
• Manage the set-up of third-party vendors, assessing initial statement of work and budget, as well as the change order process.
• Provide input to data management documents (e.g. Case Report Form, Data Validation Specification), and interface with data management representatives and sites to facilitate the delivery of study data.
• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
• Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
• Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
• Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
• Oversee the clinical trial insurance process; track approvals, revisions and renewals of certificates.
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
• Drive risk management and quality efforts to ensure study compliance.
• Manage set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
• Prepare presentation material for meetings, newsletters and websites.
• Direct the study team in the implementation of audits and regulatory inspections.
• Identify areas of best practice / process improvements and knowledge share across the group.
• Contribute to review of new/amended/unique SOPs and guidance documents.
Education, Qualifications, Skills and Experience
Essential
• University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
• Deep understanding of the drug development process with minimum of 5 years clinical trial experience, of which at least 2 years are in global study management
• Experience of working with and delivering through strategic partners and 3rd party vendors
• Excellent knowledge of ICH-GCP principles
• Team orientated
• Ability to lead, coordinate and prioritise multiple tasks and deliverables
• Proactive approach
• High degree of flexibility
• Demonstrated verbal and written communication skills
• Good negotiation and collaboration skills
• Demonstrated interpersonal and problem-solving skills
• Ability to manage change and actively seek and champion more efficient and effective ways of working
• Ability to coach & act as a buddy for more junior colleagues
• Some travel may be required
Desirable
• Early phase oncology clinical trial experience
Key Relationships to reach solutions
Reports to: Group Director Study Operations
Other key internal relationships:
Study Leader - Early Oncology Clinical
Study Operations
Site Management and Monitoring
Early Clinical Data Management and Biometrics
Clinical Sample and Bioanalytical Science
Regulatory and Patient Safety
Supply Chain
Quality, Training and Risk Management
External Service Providers
Third Party Vendors
Investigators and Site Staff
Please apply today to discuss more details over an informal telephone at your convenience.