Chiesi Farmaceutici is looking for a Clinical Trial Administrator.
> Participates in the completion of the RFPs in collaboration with the CPMs;
> Manages study related payment procedures with the dedicated Resource Administrator;
> Provides input for budget development and checks monthly costs invoiced to Chiesi based on planned study activities vs actual;
> Prepares / assembles study documentation (submission package to Regulatory Authorities and Ethics Committees, study documents prepared through HERMES, reviews English texts and translations, CSR, publications);
> Handles and maintains paper/electronic TMF and electronic internal repository according to ICH/GCP guidelines and European standards. Responsible for paper/electronic TMF reconciliation after study completion;
> Interacts with external providers during study conduct (CROs, monitors and, occasionally, with investigators and Hospital personnel);
> Collaborates with CPM, CTS Unit and QA in order to manage activities related to Clinical Trial Supplies: if required prepares and assembles labels, sends labels to CRO asking for certified translations in the applicable languages, prepares the CTS Request Form for validation by the CPM, Validates the CTS reconciliation at the end of the study for the CPMs to authorize the destruction;
> Organizes and/or participates Kick Off Meetings, Study Design Meetings, and phone-conferences with the CROs for the continuous update on clinical studies. May participate if required to the Investigator’s Meetings;
> Assists the eCTD team in the formatting of all documentation related to a clinical study, aimed at obtaining an electronic copy of the registration dossier;
> When required, capable of coordinating study feasibility in direct contact with study sites.
> High School and/or College Degree - Various Certifications which attest our familiarity with relevant ICH/GCP and SOPs;
> Background in similar functions or in a R&D environment;
> Knowledge of ICH / GCP Guidelines and company SOPs;
> Project management skills;
> Priority Setting;
> Self Commitment;
> Ability to work in a team.