Clinical Study Delivery Expert
hace 12 horas
About this role at TFS HealthScience, a leading global Contract Research Organization (CRO), we partner with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing, and functional service solutions. The Clinical Study Delivery Director will be responsible for the operational planning, delivery, oversight, and budget management of company-sponsored studies and/or externally sponsored studies and/or Early Access Programs.
**Key Responsibilities**:
- Early input into evidence generation planning
- Contribute to continuous development of Evidence Delivery
- Input into Study Design Concept (SDC)
- Accountable for protocol Manage Study Governance (post SDC)
- External Service Provider Management Stakeholder Management Manage study finance Other Project Management activities
In addition, the Clinical Study Delivery Director will support TFS HealthScience's continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practices, and contributing to the development and maintenance of guidance documents and training materials. This position will focus on one of the three main types of work: Company Sponsored Observational and Interventional Research, Externally Sponsored Scientific Research, or Early Access/Named Patient Supplies Requirements.
**Requirements**:
- Bachelor's degree required preferably in medical or biological science or equivalent by experience
- Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process, and relevant guidelines (e.g., GCP/ICH) for a specific therapeutic and geographical area
- Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management, and use of associated tools
- Scientific awareness and extensive knowledge of observational study guidelines and SOPs
- Extensive knowledge of early and late-stage Pharmaceutical Development
- Ability to effectively work with Clinical Research Organisations/External Providers
- Proven ability to interact widely and effectively within the company across regions, functions, and cultures
- Experience and knowledge within compliant management of Externally Sponsored Scientific Research
- Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
- Open to periods of travel
TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant, see the privacy notice for further details. TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity, or any other reason prohibited by law in provision of employment opportunities and benefits.
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