Clinical Operations Specialist

1 semana atrás


Porto, 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, comonitoring, 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 interdepartment 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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