Global Clinical Trial Leader 100
Global Clinical Trial Leader 100
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Noema Pharma is a clinicalstage biotech company targeting debilitating central nervous system (CNS) disorders characterized by imbalanced neuronal networks.
At Noema Pharma every patient matters.
Our pipeline contains novel therapies designed to address debilitating CNS disorders in order to improve quality of life and patient outcomes.
We partner with patients their families and caregivers and healthcare professionals to provide a comprehensive approach that goes beyond treating symptoms to ensure that patients experiences perspectives needs and priorities are meaningfully incorporated into our work.
You will be a member of a crossfunctional Clinical Trial Team driving crossfunctional interfaces and providing direction and guidance to the team for successful trial execution.
Tasks
- Lead the planning execution and management of global clinical trials in neuroscience from initiation to completion.
- Collaborate with crossfunctional teams including clinical operations clinical development regulatory affairs and data management to ensure the successful implementation of clinical trial protocols.
- Develop and oversee clinical trial budgets timelines and resource allocations ensuring adherence to quality standards and regulatory requirements.
- Interface with key stakeholders including CROs investigators key opinion leaders and study sites fostering strong relationships and effective communication.
- Monitor trial progress review data quality identify and address potential issues and implement corrective actions as necessary.
- Stay current with industry trends regulatory guidelines and scientific advancements in oncology incorporating relevant knowledge into trial strategies.
- Contribute to the development of clinical development plans and study protocols. Ensures clinical trial is inspectionready at all time and Trial Master File (TMF) completion including TMF plan is in place and ongoing QC activities are performed to always ensure TMF completeness.
- Contributes to process improvements or acts as Subject Matter Expert for SOP development/update or training.
- Coaches new clinical trial colleagues during their onboarding as assigned.
Requirements
- Advanced degree in a relevant scientific discipline (PhD MS MPH or equivalent).
- At least 7 years of experience in clinical trial management in neuroscience including project management
- Proven track record of successfully leading global clinical trials from inception to completion mainly in Phase II & Phase III.
- Indepth knowledge of GCP ICH guidelines EU CTR US FDA CFR and other relevan tregulatory requirements.
- Experience with health authority inspections (FDA/EMA) and audits preferred.
- Strong leadership and communication skills with the ability to collaborate effectively across diverse teams and cultures.
- Exceptional organizational and problemsolving abilities.
Proficiency in project management tools and systems. - Demonstrated ability to effectively forecast and manage trial budget.
- Fluent in English (any another European language are an asset).
- Work permit: Swiss or EC national with appropriate work permit
If your profile matches the above description we are looking forward to your application.
Employment Type
Full Time
