What do we do?
We are a Spanish pharmaceutical company engaged in the research and development, manufacturing and marketing of small molecules and biological medical products.
We likewise use our sales channels to market a number of licensed pharmaceutical products, imaging contrast agents and other products for hospital use, as well as OTC pharmaceuticals.
All of this is carried out through our specialized sales team formed by more than 260 people who promote the products with specialized medical professionals and in hospitals and pharmacies.
What will you do?
o Work in accordance with the standard work procedures of Laboratorios Farmacéuticos ROVI S.A. of the UDMI unit, Good Clinical Practices and current legislation.
o Monitoring the performance of Clinical Trials.
o 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.
o Work in accordance with meeting deadlines.
o Coordinate study start-up and conduct of the study.
o Collaborate in the selection of suitably qualified suppliers to perform each of the subcontracted tasks.
o 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.
o Contribute to the preparation of ROVI's internal Monitoring Plan.
o 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.
o Plan and manage clinical monitoring activities.
o Review the Monitoring Plan.
o Review/approve all plans necessary for the conduct of the study.
o Review study documents (Protocol, Informed Consents, subject materials, etc).
o Reviewing the site initiation package to give the green light to send the medication.
o Supervision of monitoring activities.
o Review that site closure is carried out in line with Rovi's procedures.
o Regularly supervise the management of the CRO.
o Conduct monitoring supervision visits.
o 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".
o 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.
o Follow-up/resolution of audit findings.
o Review of financial issues and invoicing and payments as defined in the contract.
o Escalate important issues or any potential quality issues to ROVI's Clinical Operations Manager.
Training:
Advanced degree in Medicine, Pharmacy or other Health Sciences.
Languages:
Spanish: High level in reading, speaking and writing.
English: high level in reading, speaking, and writing (B2 or higher).
Experience:
At least 4 years of experience in Clinical Research.
Skills/Competence:
Excellent organizational and communication skills.
MS Office (intermediate-high level). High level of Excel.
Occasional travel.
Your contract type will be:
Indefinite
The required education for the job is:
Bachelors Degree: Pharmacy (obligatorio)
The experience for this job is:
From 3 to 5 years