Guarantee an adequate execution and follow-up of the clinical trials under their responsibility in the established timelines and quality.
- Define the Clinical Trial Plan and prepare its project plan for trials under their supervision, communicating any deviation to the Medical Director and guaranteeing the implementation of corrective measures for its adjustment.
- Prepare the budget for the CTs under their supervision and conduct financial control of the project through the supervision of the outsourced activities and the billing to partners on clinical co-developments.
- Prepare the requirements for the CT in terms of drugs and provide the global product needs and monthly provisions to the logistics department during the study.
- Select CROs and external vendors required for the CT, as well as control all their activities ensuring that they are performed according to the plan in terms of costs, quality and times.
- Identify the most adequate country to implement the CT, according to the defined plan and select the centers and researchers participating in the study.
- Participate in the constitution of independent committees (IDMC, IRC, etc.) involved in the clinical trial, coordinate their activities and maintain the file and traceability of all documents necessary for dossier purposes.
- Prepare essential documents of the CT in conjunction with the product doctor, such as protocol, ICF core, amendments, etc.
- Coordinate the approvals of the clinical trial and the amendments to protocols under their responsibility, as well as guarantee the edition of new protocol versions, when applicable.
- Approve the monitoring plan for the study and the corresponding interventions.
- Review and approve all the materials and guides required for the clinical trial.
- Supervise all the necessary documentation from the participant centers, in order to obtain approvals from CEICs and local Health Authorities.
- Organize and participate in the CT’s researchers meetings of the CT under their responsibility.
- Maintain communication with researchers and partners in the co-development of the study, ensuring monthly updates, kick off meetings and continuous follow-up of the study.
- Supervise the files of the delegated centers, performing periodical Quality Controls.
- Guarantee compliance with the Company’s procedures, Good Clinical Practices and applicable regulations in all the CTs under their responsibility.
- Represent the clinical operations department in the project meetings at the Company.
- Education: Degree in Health Sciences, preferably Medicine.
- Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
- Experience (years/area): +4 years of experience as clinical trial monitor and at least 2 years of experience as international study coordinator. Experience in budget preparation and management and team management is required. Experience in GCP Quality Control or other areas related to development of clinical trials, such as pharmacokinetics, security, etc., will be very valuable. Experience in execution of CTs in emerging countries will be an asset.
- Specific Knowledge: Knowledge of international regulations for clinical trials.
- Travels: Willingness to travel.