Clinical Trial Assistant (CTA) - TMF Specialist — IBSA Institut Biochimique

Full description

The resource will provide support to the Clinical Research Manager (CRM) in the administrative and operational aspects of preclinical and clinical studies in all their stages, in accordance with the internal SOPs, in order to ensure the correct start, development and completion of clinical trials.

Trial Master File (TMF)

The main activity concerns the organization and maintenance of the Trial Master File (TMF) through the management and archiving of the study documentation in both paper and electronic format.

Paper TMF (pTMF)

• Setup of pTMF;

• Verification (quality check) and storage of study documentation;

• Periodic checks of completeness of TMF during study and recovery of documentation to be stored;

• TMF Workbook Maintenance (PCRS TMF documents tracker);

• Upload of all TMF documentation on SharePoint to maintain an electronic version of the TMF;

• At the end of the study, verification and union of paper collectors for final storage;

• Final verification of TMF completeness before archiving.

IBSA electronic TMF (Veeva)

• Preparation of the TMF Plan and study setup in Veeva (Expected Documents List) in collaboration with CRM;

• Periodic checks of completeness of eTMF during study and recovery of documents to be uploaded;

• Periodic activity of eTMF oversight;

• Active role in drafting and reviewing documents within the system;

• Quality check of documents uploaded by third parties (CRO, etc.);

• Support and collaboration with CRO for the operational use of eTMF;

Other eTMF provider (repository eTMF)

• Preparation of the TMF Plan in collaboration with CRM;

• Periodic checks of eTMF during the study and recovery of documents to be stored;

• Final verification of eTMF completeness before archiving.

Operational activities in clinical studies

• CRM support in the finalization of the study documentation for regulatory submissions and its follow-up;

• Correspondence with CRO and clinical centers and support in everyday operations;

• Contacts with external brokers for insurance issues (civil liability policies for patients, any contractual changes, final balance at the end of the study);

• Contacts with the Global Supply Chain Department and/or external suppliers for the purchase of Reference Drugs and Auxiliary Medicinal Products (AMPs), such as rescue medicines or other treatments provided by the study protocol, in support of IMPs/IMDs;

• CRM support in the preparation and finalization of requests for packaging of study drugs and related attachments (labelling, instructions, etc.);

• Contacts with the Product Development Department for packaging details, label proofs approval, organization of transfer of study products for secondary packaging and delivery to the PCRS warehouse;

• Preparation of shipments of study products and updating of relevant data in the ERP IBSA system, in collaboration with the supervisory warehouse and the team;

• Contacts with the Shipping Department for the shipment of study products and related material (if applicable) to clinical centers or to CRO/distributors, with support in the finalization of the shipping documents of the study;

• Organization of shipment of reference samples of clinical trials (when applicable) to EU QP;

• Constant update of the Excel inventory file for study products and reference samples stored in the PCRS warehouse and, in collaboration with the supervisory warehouse and team, organization of disposal of expired products and allocation of new study products;

• Verification of invoices received by CRO, clinical centers, distributors and other providers or service providers and cost monitoring of clinical studies;

• Inserting and tracking into the SAP system of invoices relating to clinical trials or consulting agreements; contacts with the Accounting Department for payment status monitoring;

• Participation in the periodic meetings of the study teams.

Other activities within PCRS

• Active role in the revision of Standard Operating Procedures (SOPs) and participation in its internal meetings;

• Active role in the preparation and updating of the Working Instructions;

• Participation in regular meetings of the CTA team for updating, coordinating activities and support/training of new team members;

• Current use of IT tools (DocuSign, Adiuto, SharePoint, Teams, Guest Registration, ERP codes, etc.);

• Other general secretariat activities in support of the PCRS group.