Covance Italy is looking for SCRA /Clinical Team Leader with quality e
Nr ref.: /JOBS.pl
Do you demonstrate strong quality and clinical research knowledge? Strong understanding of clinical trial planning, management and metrics? Are you able to effectively build and maintain professional relationships with investigators and other external stakeholders? Are you able to lead across several dimensions simultaneously? If YES you are the right person to join our Team in Rome office.
We are currently recruiting experienced Senior Clinical Research Associates with solid quality background!
You will be responsible for quality and compliance in assigned protocols in the country, overseeing CRAs and CTCs, collaborating with functional outsourcing vendors, investigators and internally with Regulatory etc.
About the Job: - Conducting on-site Accompanied Field Visit activities (Quality Control Visits) for CoSource staff - GCP, Regulations, Country SOPs - Audits, inspections, CAPAs - Undertaking country trend analysis and impact assessments of audit and/or inspection findings and analysis of FA QC activities like Co-Monitoring, to be taken into consideration for country/regional QC plan - Effectively communicating management strategies, policies and procedures in conjunction with leadership teams - Developing and maintaining effective relationships with client management teams to manage CoSource staff in a matrix environment - Maintaining good working relationships with internal and external clients to ensure opportunity for supporting additional new business - Forecasts country resource needs - Oversees country and site validations, site selection and recruitment in assigned protocols; responsible for clinical trial education to sites
Education/ qualifications: - University/college degree (life science preferred), or certification in a related allied health profession - In lieu of the above requirement, candidates with several years of relevant clinical research experience in pharmaceutical or CRO industries will be considered - Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries - Thorough understanding of the drug development process - Fluent in local office language and in English - Relevant clinical research experience in a pharmaceutical company or CRO
About You: - ability to effectively conduct clinical studies and develop the pipeline, - maintaining local regulatory and compliance requirements in countries - ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, - strong understanding of local regulatory environment, - ability to identify problems, conflicts and opportunities early and lead, - communication and empathic skills - ability to coordinate and lead local teams to high performance