Clinical Trial Administrator
6 giorni fa
On behalf of our Client a global pharmaceutical company, IQVIA is looking for a** Clinical Trial Administrator for Early Phase Study **who can join an exciting working environment in a dynamic atmosphere.
**RESPONSIBILITIES**:
- ** Study documentation and Trial Master File**
- Prepares/assembles study documentation, including but not limited to submission package to Regulatory Authorities and Ethics Committees, study documents prepared through Company's EDMS (HERMES), reviews English texts and translations and is in charge of formatting study documents, such as study protocols, clinical study reports, etc.
- Follows the process in place for the publication of an article related to a clinical study
- Requests ad-hoc study insurance policies and ensures the maintenance during the entire study lifecycle
- Manages study related legal documentation (license agreements, translation agreements, CDAs), in collaboration with CPM, Legal department and external providers and through the EMDS (DIKESI)
- Responsible for electronic TMF set-up and maintenance during the study, oversight of filing documentation completeness, through ongoing quality checks and metrics, oversight of CRO filing activities in the eTMF
- Responsible for eTMF and paper TMF reconciliation after study completion
- ** CRO Cost and Payment Process**
- Participates in the completion and review of Request for Proposals sent to CROs in collaboration with the CPMs
- Follows the CRO Awarding Process and prepares the necessary procedure in SAP for the payment of monthly invoices.
CTA also follows study purchase process in SAP according to Company policies
- Provides input for budget development at Forecast, Preclosing; checks monthly costs invoiced to the Company based on planned study activities vs actual through our dedicated tool (TTP) and ensures that invoices received are in line with all that is indicated in the TTP; manages the Investigator Fees reconciliation and support the CPMs in all activities related to budget operations
- ** CPM support and CRO oversight**
- Organizes and participates in 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 and other study specific meetings
- Supports CPM in CRO oversight, ensures that the trial complies to SOPs and all necessary quality standards
- Collaborates with the CPM with corrective and preventive actions, in case of deviations and following audits
- Reviews SOPs, if required
- Collaborates with CPM and CTS Unit for the preparation of CTS request form and the CTS reconciliation at site verification
- ** CSR and eCTD support**
- 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
**REQUIREMENTS AND SKILLS**:
- Previous experience as CTA minimum 3/4 years
- High School and/or College Degree
- Various Certifications which attest familiarity with relevant ICH/GCP and SOPs.
- Project management skills
- Pro-activeness
- Self-determination
- Initiative
- Reliability
- English proficient
**TYPE OF CONTRACT**:
Permanent contract
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