Clinical Operations Specialist

2 meses atrás

Porto, Portugal Bial Tempo inteiro

**MISSION**:
Support and monitor the clinical trial operations activities from phase I to phase IV sponsored by BIAL, according to the Clinical Development Plan.

**MAIN ATTRIBUTIONS AND RESPONSABILITIES**:

- Support on clinical trials implementation: identification of third party’s vendors (e.g., CROs; bioanalytical/central/genetics labs), review of proposals, preparation of bid defense meetings, negotiation of master and project agreements, regulatory and ethical activities;
- Support on clinical trials conduct: country and site feasibility, site selection, site contracts negotiation, site training/monitoring/motivation, patient recruitment and retention initiatives;
- Support and assist in study progress monitoring (quality management, monitoring visit reports review, co-monitoring, protocol deviation, risk management, audits, etc.);
- Support clinical trials oversight: preparation of study plans (e.g., clinical monitoring plan, protocol deviations plan, data management plan);
- Support evaluation, planning and control of budget and timelines;
- Collaborate in the review of study documents (from Clinical trial Outline to Clinical Study Report);
- Comply with good clinical practice, SOPs, Quality, Health and Safety Policies;
- Collaborate on other department and inter-department activities/tasks as needed, such as purchasing, pharmacovigilance, medical affairs.

**REQUIREMENTS AND SKILLS**:

- Life Sciences Degree;
- At least 2 years of operational experience of clinical study execution in a pharmaceutical company or contract research organization;
- Clinical research experience within neurosciences area (preferred);
- Project management and teamwork skills;
- Fluency in English (Written and Spoken);
- Availability to travel;
- Skilled for understanding and communicating scientific information;
- Ability to think strategically and willingness to take on new responsibilities.

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