Clinical Research Manager

vor 1 Woche

Basel, Basel-Stadt, Schweiz Vectura Fertin Pharma Vollzeit

About Vectura Fertin Pharma:

We strive to make a positive difference in the lives of patients and consumers through science, insight, and innovation. We empower healthier lifestyles and target specific unmet needs by being innovative, optimizing formulas, and applying rigorous scientific standards.

Job Description:

We are seeking a highly skilled Clinical Trial Manager to support our ongoing trials in Phase I and II. The successful candidate will work closely with our CRO partners, leading on study documents to ensure efficient study delivery. This is an opportunity to make a direct impact on revolutionary inhaled treatments.

About Your Role:
  • You will be responsible for supporting the delivery of clinical studies to time, cost, and quality from Clinical Study Protocol development through to study archiving.
  • You will work cross-functionally building partnerships with internal and external partners to deliver and provide oversight to ensure successful study delivery.
  • You will maintain and facilitate interactions with internal functions including Data Management, Procurement, Regulatory, Patient Safety, and QA, and external functions including the CROs.
Responsibilities:
  • Prepare delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc.) and external service provider related documents (e.g. specifications).
  • Support the Clinical Operations Lead in project management as per agreed delegation, e.g. drug supplies, vendor management.
  • Collaborate closely with Clinical Supply Chain or external service providers to ensure the supply of study materials and Investigational product.
  • Assist with the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting).
  • Monitor study conduct and progress, identifying and resolving risks and issues which may impact delivery of the study to the necessary quality, timeline, or budget objectives with the Clinical Operations Lead.
Experience Required:
  • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
  • Minimum 3 years experience in a similar role within the pharmaceutical industry supporting clinical trial operations.
  • Leading one or more Clinical Trials (any phase) is essential.
  • Shown project management, organizational, and analytical skills.
  • Knowledge of clinical development / drug development process across various phases and therapy areas as well as relevant knowledge of international guidelines ICG-GCP.

We embrace hybrid and flexible working and are centered on delivering a 'purpose-driven' experience for all our employees.

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