Clinical Trial Manager
vor 1 Woche
Category: Clinical, Medical and Regulatory Affairs
Contract Type: Permanent
Contract Duration: Full Time
Location: Basel + hybrid working
Job Advert: Clinical Trial ManagerAbout Aspeya:
At Aspeya we strive to make a positive difference to the lives of patients and consumers through science, insight, and innovation. We are on a journey to empower healthier lifestyles and target specific unmet needs. We do this by being innovative, optimizing formulas, and applying rigorous scientific standards. We trust a bold and confident approach, without compromising integrity. Join us and be part of a dynamic, future-thinking environment where your contributions can make a positive difference to people's lives.
About your role:We are excited to be hiring a new Clinical Trial Manager to support our ongoing trials in Phase I and II. We require extra resources in the Clinical team to manage end-to-end activities with our CRO partners, and lead on study documents to ensure efficient study delivery. This is an opportunity to make a direct impact on revolutionary inhaled treatments. You will work amongst our global function in Switzerland consisting of Clinical Physicians, Clinical Scientists, Data Management and Biostatistics, Regulatory, QA and our leadership.
Responsibilities:- Support the delivery of clinical studies to time, cost and quality from Clinical Study Protocol development through to study archiving.
- Work cross-functionally building partnerships with internal and external partners to deliver and provide oversight to ensure successful study delivery.
- Maintain and facilitate interactions with internal functions including Data Management, Procurement, Regulatory, Patient Safety and QA, and external functions including the CROs.
- Lead and/or participate in the preparation of 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.
- Ensure the supply of study materials and Investigational product by collaborating closely with Clinical Supply Chain or external service providers.
- Help support the Clinical Operations Lead with budget management, such as external service provider invoice reconciliation.
- Ensure studies are always inspection-ready according to ICH-GCP, SOP's and relevant policies/guidelines.
- Ensure that all study documents in scope of Clinical Study Manager's responsibilities are completed and verified for quality in the Trial Master File.
- 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.
- Contribute to ad hoc team productivity and efficiency by providing direction and facilitating positive team dynamics.
- Provide input into non-drug project work including training activities and the development of procedures as needed.
- Responsible for collecting and reporting Adverse Events in accordance with policies and SOPs.
- 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.
- Global clinical research experience in managing multiple countries.
- Vendor management experience.
- Sponsor experience.
We embrace hybrid and flexible working and are centered on delivering a 'purpose-driven' experience for all our employees.
ApplyJoin our journey At Aspeya, your ideas matter. Apply now and contribute to meaningful projects that improve lives worldwide.
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