Description
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Senior Clinical Manager (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM
Ort: in Basel region
Branche: Sonstige Überlassung von Arbeitskräften
Ihre Aufgaben:
- Support CTH in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include the development of specific sections of protocol and related documents, the development of study tools, guidelines and training materials, the management of clinical study material, the implementation of issue resolution plan and the preparation of clinical outsourcing specifications
- Responsibility for management of Contract Research Organizations (CROs)
- Ensure adherence to scope of work within timelines and budget
- Support the development, management and tracking of trial budget working closely with the TA program operations group
- Support CTH in managing interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and local medical organizations
- Accountable for accuracy of trial information in all trial databases and tracking systems
- Contribute to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing
- May participate in the organization and logistics of various oversight or Advisory Boards
- Point of contact for managing/answering questions related to trial procedures and patients’ eligibility
- Draft CTT meeting minutes. Participate in International Clinical Team meetings
- May organize and chair trial sub-teams within the scope of delegated responsibilities
- Assist with program level activities (e.g., tracking of CD&MA brand-related publications, development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions)
- Responsibility for the implementation of best practices and standards for trial management within the TA, including sharing lessons learned
Ihre Qualifikation
- Advanced degree or equivalent education/degree in life science/healthcare required if no previous experience in clinical researchor
- Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with first experience in clinical research
Skills:
- Clinical Project Management
Keywords: clinical study IB Pharma