Clinical Trial Assistant

Tasks:
Provide general administrative support to the Clinical Development team in all aspects of clinical study projects from study planning to close-out and study report
Participate in establishing, reviewing, and maintaining company standard operating procedures (SOPs), Process Documents related to clinical operations
Participate in organizing and maintaining Trial Master File
Participate in the development/review of study plans, documents, and study-specific instructions (e.g.: clinical protocol, informed consent, project plan, deviation plan etc.) to ensure that the program meets ICH-GCP and applicable regulations.
Work together with the Clinical Development team in selection of CROs, vendors
Take part in the regular sponsor oversight procedures to verify that Clinical Research Organization (CRO) and other vendors fulfill their obligations as agreed.
Enter safety information to a Safety Database and perform regular reconciliation
Participate in project meetings, conference, and training calls with Investigators, study sites and write meeting minutes when applicable.
Assist in site management and oversight for studies were a CRO is not contracted.
Assist with ordering/dispatch and tracking of trial materials (e.g., study binders. lab supplies, labels etc.)
Assist in review and reconciliation of clinical data outputs (if required).
Assist with review of Investigator/Site invoices for accuracy (i.e., reconcile against the case report forms (CRFs) and contract, if required)

Experience:
A University degree (BSc, MSc) in life science discipline
Good knowledge of clinical research regulatory requirements and Good Clinical Practice (GCP)
Completed CDD course is a merit
Experience from administrative support or project management
Early phase clinical trial experience (preferred pharmaceutical environment) or previous CRA experience is an advantage
Experience with gene therapy products/ATMPs is an advantage
Knowledge in oncology and immunology is an advantage


Profile:
Strong organizational skills
Ability to work in group setting and independently
Attention to details while maintaining an overview on the project
Ability to adjust to reality and changing priorities with short notice
Strong communication skills,
Good in English and Swedish, both verbal and written.
Ability to focus and maintain a professional and positive attitude
Computer skills and well experienced working in Microsoft Word, Excel, and PowerPoint