Se necesita Clinical Research Associate II y III
Central point of communication/contact between Novartis and the Investigator and Investiga-tional site personnel to ensure:
• That all trial related activities are conducted at site following GCP and Novartis stand-ards (processes and SOPs),
• That agreed targets (e.g. number of patients, key milestones) are met The senior CRA is able to work without supervision on complex trials
Study Planning: Contribute to the identification of new sites for CT; analyze capability and support CRMA and CSM in making recommendation for trial inclusion.
Assume ambassadorial role to facilitate communication between sites and NVS CPO to increase value proposition to investigators.
Facilitate the preparation and collection of site and country level doc.
Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators.
Ensure adherence to payment schedule.
Participate in the review of the monitoring plans.
Provide input regarding the protocol, feasibility and amendments.
Provide input regarding monitoring strategies
Study Start-up: Assist CRMA with protocol training and logistics for local CRAs.
Facilitate, standardize and coordinate CRA, cCRA and ucCRA activities across a coun-try/cluster.
Prepare and circulate site selection visit agenda with all appropriate appendices to all local CRAs.
Ensure that all local CRAs are provided with all tools necessary to conduct the trial, and work with the CSM and CTA to ensure that all necessary site tools are circulated to sites.
Prepare tools in local language in order to help sites in conducting the trial.
• Must have a Degree in Scientific, Healthcare or Administrative Discipline;
• It is a plus if you have a Science Master or PhD;
• Must have minimum 3 to 8 years (depend on the position) of experience in Clinical Research, Trial Execution and Drug Development;
• Must have experience in Clinical Trials Phases II, III, IV;
• Must have strong Project Management skills for the Clinical Trials;
• Must have experience in the following Therapeutic Areas – Oncology, Hematology, VIH, Respiratory, Cardiovascular or similar;
• Must have experience in CROs or Clusters managements;
• Has team player skills;
• Advanced English skills (written, reading and speaking).
The Novartis Group of Companies seek equal opportunities and we are proud of the diversity of our teams. In this company we do not discriminate any person or social group by their nationality, language, sex, gender, age, disability, social status, indigenous identity, gender identity, physical appearance, health conditions, religion, ideologies, sexual preference or orientation, for having tattoos or any other reason that has the purpose of preventing the enjoyment and exercise of human rights.