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Clinical Trial Operations Manager
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Design
Projektbeschreibung
We are recruiting for a Trial Operations Manager for a global position within a multinational pharmaceutical company.
You will be responsible for the oversight and coordination of the global monitoring operational aspects of assigned clinical trials, from start-up to close-out. This role is a great mix of strategic and operational duties where planning, feasibility assessment, trial allocation, start-up activities coordination, patient recruitment, clinical and delivery of data, sites close-out, audit and inspection preparation activities will be some of the main responsibilities.
This is a 1 year contract position; with further extensions in place.
Responsibilities:
- In compliance with regulations you will execute trials according to plans and timeline, commitments in alignment with strategy to achieve global and regional objectives.
- Communicates planned milestones to Trial Monitoring stakeholders and update on operational activities at the Region/Country level, during the course of the trials to meet Objectives
- Participates in the development of innovative solutions in clinical trial planning and execution, including country, site and patient engagement to ensure the delivery of assigned studies on time
- Actively participates in the development of reporting methodologies, and implements performance reporting for trial monitoring, ensures accurate and complete operational data within corporate systems.
- Develops planning for prospective management of clinical trials including operational risks for each phase of the trial (Feasibility/allocation, Start-up, Data collection and cleaning) using available internal and external resources (patients' incidence, competitive landscape regional strategies, data, statistical plan)
- Is accountable for recruitment activities; responsible for forecasting, setting up contingency planning to ensure recruitment targets are achieved in accordance with trial execution plan.
- Evaluates potential challenges/risks within the protocol and operational aspects of the study in line; assessing impacts, developing risk management plans and communicating/escalating to appropriate stakeholder
Requirements
- Advanced degree, preferably in life sciences
- Fluent English (oral and written)
- 3+ years' experience in clinical research, in planning/executing and/or monitoring clinical trials
- Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
- Demonstrated ability to collaborate across partner functions in a Matrix environment, without direct reports, but can coordinate the activities of others
- Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred
- Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision
- Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations.
Please contact Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
You will be responsible for the oversight and coordination of the global monitoring operational aspects of assigned clinical trials, from start-up to close-out. This role is a great mix of strategic and operational duties where planning, feasibility assessment, trial allocation, start-up activities coordination, patient recruitment, clinical and delivery of data, sites close-out, audit and inspection preparation activities will be some of the main responsibilities.
This is a 1 year contract position; with further extensions in place.
Responsibilities:
- In compliance with regulations you will execute trials according to plans and timeline, commitments in alignment with strategy to achieve global and regional objectives.
- Communicates planned milestones to Trial Monitoring stakeholders and update on operational activities at the Region/Country level, during the course of the trials to meet Objectives
- Participates in the development of innovative solutions in clinical trial planning and execution, including country, site and patient engagement to ensure the delivery of assigned studies on time
- Actively participates in the development of reporting methodologies, and implements performance reporting for trial monitoring, ensures accurate and complete operational data within corporate systems.
- Develops planning for prospective management of clinical trials including operational risks for each phase of the trial (Feasibility/allocation, Start-up, Data collection and cleaning) using available internal and external resources (patients' incidence, competitive landscape regional strategies, data, statistical plan)
- Is accountable for recruitment activities; responsible for forecasting, setting up contingency planning to ensure recruitment targets are achieved in accordance with trial execution plan.
- Evaluates potential challenges/risks within the protocol and operational aspects of the study in line; assessing impacts, developing risk management plans and communicating/escalating to appropriate stakeholder
Requirements
- Advanced degree, preferably in life sciences
- Fluent English (oral and written)
- 3+ years' experience in clinical research, in planning/executing and/or monitoring clinical trials
- Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
- Demonstrated ability to collaborate across partner functions in a Matrix environment, without direct reports, but can coordinate the activities of others
- Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred
- Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision
- Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations.
Please contact Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design