Senior Clinical Trial Assistant

Flexsis; Allschwil; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Flexsis is seeking a Senior Clinical Trial Assistant to lead local medical activities, align with regional strategies, and collaborate across teams to advance patient outcomes and business goals.

The role provides senior operational and administrative support to Clinical Operations Managers and teams, manages consultancy agreements, insurance activities, and eTMF documentation to ensure inspection readiness.

Qualifikationen

• Bachelor's degree is required; master's degree preferred.
• 2 years of experience in clinical research, clinical operations, clinical trial administration, or pharmaceutical project support.
• 2 years of experience in supporting global clinical trials within pharmaceutical and CRO environments.
• 1 year of experience with electronic Trial Master Files (eTMF), including document filing, QC reviews, and inspection readiness activities and in organizing and supporting investigator meetings, study team meetings, workshops, and conferences (virtual and onsite)

Aufgaben

• Provide senior operational and administrative support to Clinical Operations Managers and Clinical Operations/Clinical Science teams.
• Manage consultancy agreements supporting Clinical Operations and Clinical Sciences, including preparing new agreements and amendments, creating and monitoring purchase orders, reviewing invoices for accuracy and alignment with contracts.
• Coordinate and maintain clinical trial insurance activities, ensuring timely documentation, renewal, and filing.
• Act as a liaison between Clinical Operations, Clinical Sciences, Finance, Legal, external consultants, vendors, clients and compliance.
• Plan, coordinate, and document international and regional study meetings and events, both virtual and in-person.
• Support Transfer of Value reconciliation and maintain documentation required for transparency reporting.
• Assist team members with administrative tasks including correspondence, courier shipments, contract signature coordination via Adobe Sign, invoice processing.
• Maintain and archive clinical trial documentation in the eTMF, and perform quality checks to support inspection readiness.
• Perform other duties as assigned.

Kenntnisse

Administrative support

Clinical operations

Vendor management

Cross-functional collaboration

Documentation control

eTMF familiarity

Ausbildung

Bachelor's degree

Master's degree preferred

Tools

Adobe Sign

Jobbeschreibung

Every day, we rise to the challenge to make a difference, and here’s how the Senior Clinical Trial Assistant role will make an impact:

This position will lead the local medical team, ensure alignment and execution of local/regional medical strategy, collaborate with cross-functional teams and influence key healthcare stakeholders to drive meaningful impact for patients and the business.

• Provide senior operational and administrative support to Clinical Operations Managers and Clinical Operations/Clinical Science teams.
• Manage consultancy agreements supporting Clinical Operations and Clinical Sciences, including:
• Preparing new agreements and amendments in accordance with clients policies and compliance requirements. Creating, maintaining, and monitoring Purchase Orders. Reviewing invoices and supporting documentation for accuracy, completeness, and alignment with contracted services. Ensuring appropriate documentation and filing of service reviews, invoices, and related records
• Coordinate and maintain clinical trial insurance activities, ensuring timely documentation, renewal, and filing.
• Act as a liaison between:
• Clinical Operations Clinical Sciences Finance Legal External consultants and vendors clients compliance Plan, coordinate, and document international and regional study meetings and events, both virtual and in-person.
• Support Transfer of Value reconciliation and maintain the documentation required for transparency reporting.
• Proactively support team members with administrative and operational activities, including:
• Internal and external correspondence Courier shipments Contract signature coordination through Adobe electronic signature Invoice processing and follow-up IT requests
• Ensure the accurate and timely maintenance and archiving of clinical trial documentation in the electronic Trial Master File (eTMF).
• Perform ongoing eTMF quality checks and document reviews to support completeness, accuracy, timeliness, and inspection readiness.
• Perform other duties and responsibilities as assigned.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills, and experiences:

• A bachelor’s degree is required and a master’s degree is preferred
• 2 years of experience in clinical research, clinical operations, clinical trial administration, or pharmaceutical project support are required
• 2 years of experience in supporting global clinical trials within pharmaceutical and CRO environments
• 1 year of experience with electronic Trial Master Files (eTMF), including document filing, QC reviews, and inspection readiness activities and in organizing and supporting investigator meetings, study team meetings, workshops, and conferences (virtual and onsite)