Clinical Operations - Liver Disease
ProClinical is partnering with a leading biopharmaceutical company to advertise a vacancy for a Clinical Operations - Liver Disease position. This organisation, whose scientific research has resulted in multiple marketed products and a pipeline of late-stage drug candidates, is seeking for an applicant to join their team in California. This is an exciting opportunity to join an internationally renowned company that prides itself on its unmatched patient access programs and help ensure that medications are available to those who could otherwise not afford them.
- Providing general administrative and data input.
- Providing input and assisting with the harmonization of Clinical Operations databases and tracking tools.
- Assisting in the maintaining of clinical information and training of Clinical Operations personnel in the clinical trials database (GILDA).
- Tracking and filing documents in the Trial Master File (TMF) or VeevaVault (written and electronic).
- Processing drug shipments, drug returns, and assisting with in-house drug reconciliation.
- Assisting with the development of documents for site binders, along with their assembly and distribution.
- Drafting meeting agendas and assisting in preparing meeting minutes.
- Interacting with other departments, as directed, to complete assigned tasks.
- Assisting with monitoring visits under the direct supervision of senior staff.
Skills and Requirements:
- A thorough knowledge of DGA and/or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sherron Howard at +44 267 435 8600 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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