Clinical Trial Associate (SMF) - Temporary

About the role

TFS HealthScience is a global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. As part of its Functional Solutions team, the Clinical Trial Associate works with one sponsor, a global pharmaceutical or biotechnology company, and is responsible for organizing and maintaining the Study Master File (SMF) and coordinating practical study tasks in line with company policies, SOPs and regulatory requirements.

Key responsibilities

• Work with the Study Team in initiating, maintaining and closing/final archiving of the SMF, ensuring GCP compliance
• Maintain study information in the CTMS and set up the Investigator's File as directed by the CRA
• Act as point of contact for the SMF and maintain it as directed by the Lead CRA/Project Manager
• Coordinate study supplies, draft and assist with trial documents, tools and templates, and prepare presentation material for meetings and newsletters
• Arrange internal and external meetings, take minutes, and contribute to audit and inspection support
• Prepare the SMF for shipment to the sponsor, collect appendices for the final Clinical Study Report, and help organize routine work
• Support regulatory processes (IEC/IRBs/CA), including submissions, amendments and fees, and assist with site contracts and investigator payments
• May support remote monitoring activities such as data collection, data entry follow-up and query resolution

Required profile

• Bachelor's degree preferred
• Knowledge of GCP/ICH guidelines
• Able to work in a fast-paced environment with changing priorities

Required skills

• Good written and communication skills
• Good organizational skills
• Good software and computer skills