Clinical Trial Associate

Noema Pharma is a clinical-stage 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.

Tasks

Position Summary :

• Assists in the provision of study and / or program execution to plan in accordance with CFR, EMA, and ICH GCP regulations.
• Responsible and accountable for supporting assigned clinical study(ies) and assisting in the coordination / execution of assigned operational aspects.

Responsibilities :

• To assist the Clinical Operations team in completion of all required tasks to meet departmental and project goals.
• To support the Clinical Operations team with ongoing conduct of studies.
• To be familiar with ICH GCP, appropriate regulations, relevant SOP’s and internal tracking systems.
• To assist project teams with generating or maintaining study specific documentation and guidelines as appropriate.
• To set up, organize and maintain with quality all clinical study documentation (e.g. Trial Master File), provide oversight and quality during maintenance through to final reconciliation and archival.
• To assist in co-ordinating and tracking of vendor deliverables and progress, creating or maintaining tracking tools and systems
• To triage incoming correspondence, internal documentation, CRFs, etc., as appropriate, to responsible clinical operations team members.
• To assist in tracking of vendor payments, if applicable.
• To assist in the contact clinical sites for specific requests (e.g., enrollment updates, meeting arrangements, etc.).
• To attend project team meetings and generate meeting minutes.
• To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
• To assist in the production of slides, etc., as needed for project, departmental, vendor and / or company presentations.

Requirements

• BS / BA degree required in science / health-related field preferred, but not required.
• At least 2 years of clinical research experience in clinical trials in biotech or pharma industry.
• General understanding of the drug development process to assist in the management of deliverables, as assigned.
• Ability to manage and organize multiple priorities, while maintaining attention to detail.
• Self-motivation and able to work independently in a fast-paced, small company environment.
• Pro-active and problem-solving attitude : willing to work hands-on in a very small team with limited internal resources.
• Strong work ethics.
• Personal resilience, perseverance, energy and drive.
• Working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
• Open, effective, and proactive written and oral communication skills.
• Fluent in spoken and written English, additional languages are an asset.

Work permit : Swiss or EC national with appropriate work permit.

Noema Pharma is a biotech company developing groundbreaking therapies to address the most disabling symptoms in orphan conditions of the brain and nervous system.

Noema’s research and development is focused on understanding and meeting patient needs using our novel therapies.