Responsibilities * Work in accordance with the standard work procedures of Laboratorios Farmacéuticos ROVI S.A. of the UDMI unit, Good Clinical Practices and current legislation. * Monitoring the performance of Clinical Trials. * Supervision/oversight of the activities subcontracted to suppliers, including - but not limited to - clinical monitoring, clinical and non‑clinical suppliers, statistics, programming, medical writing and data management. * Work in accordance with meeting deadlines. * Coordinate study start‑up and conduct of the study. * Collaborate in the selection of suitably qualified suppliers to perform each of the subcontracted tasks. * Contribute to the review of the subcontracted CRO's preparation of a Communication Plan and/or Monitoring Plan for the study, and supervise its compliance. * Contribute to the preparation of ROVI's internal Monitoring Plan. * Contribute to the selection of participating research centres: review the questionnaires for pre‑selection, the criteria for selection of centres/countries, and the final list of selected centres. * Plan and manage clinical monitoring activities. * Review the Monitoring Plan. * Review/approve all plans necessary for the conduct of the study. * Review study documents (Protocol, Informed Consents, subject materials, etc). * Reviewing the site initiation package to give the green light to send the medication. * Supervision of monitoring activities. * Review that site closure is carried out in line with Rovi's procedures. * Regularly supervise the management of the CRO. * Conduct monitoring supervision visits. * Communicate to ROVI's Quality Assurance Coordinator (GCP/GVP QAC) any problem that meets (or is suspected of meeting) the criteria of a "quality problem". * Communicate to ROVI's Pharmacovigilance managers any potential problems or trends related to quality or compliance in pharmacovigilance activities performed by the CRO or any other provider. * Follow‑up/resolution of audit findings. * Review of financial issues and invoicing and payments as defined in the contract. * Escalate important issues or any potential quality issues to ROVI's Clinical Operations Manager.
Seniority Level * Mid‑Senior level Employment Type * Full‑time Job Function * Health Care Provider, Science, and Project Management Industries * Pharmaceutical Manufacturing #J-18808-Ljbffr