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Covance Spain is looking for Clinical Start-up Specialist! Nr ref.: /JOBS.pl Position: Clinical Start-up Specialist (Global Site Services division) Location: Spain/ Madrid - office based or Spain- home based Are you looking for a challenging and varied job in the world of clinical trials? Covance is one of the world's most dynamic drug development services companies, providing integrated, tailored solutions to the pharmaceutical and biotechnological industries. Today we start looking for a Clinical Start-up Specialist whose responsibilities will be : Accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally. Ownership of country and site budgets.Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversight and tracking of clinical research-related payments.Payment reconciliation at study close-out. Oversight of FCPA, DPS/OFAC,and maintenance of financial systems.Financial forecasting in conjunction with CRD. Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Interactions with IRB/IEC and Regulatory Authority for assigned protocols. Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs. Oversees CTCs as applicable. Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols.Provides support and oversight to local vendors as applicable. Oversight and coordination of local processes. Clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems. Profile: - Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related Experience - Previous Experience in clinical research required (5-7 years as e.g. CRA or GSS) - Requires ability to work effectively with a wide range of people internally and externally - Expertise of core clinical systems, tools and metrics - Good organizational and time management skills - Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project teams and investigative sites preferred - Self-motivation with the ability to work under pressure to meet deadlines - Detail and process oriented, positive attitude and approach, multi-tasking capability - Computer proficiency (MS Office - Word, Excel, Power Point and Internet skills), aptitude for training, capable of operating standard office equipment (e.g. fax, copier etc.). - Fluent in local office languages and English, both written and verbal if applicable Education/Qualifications Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related Experience Previous Experience in clinical research required (5-7 years as e.g. CRA or GSS) - Requires ability to work effectively with a wide range of people internally and externally - Expertise of core clinical systems, tools and metrics- Good organizational and time management skills - Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project teams and investigative sites preferred - Good communication skills, oral and written - Self-motivation with the ability to work under pressure to meet deadlines - Works well independently as well as in a team environment - Detail and process oriented - Positive attitude and approach - Interact with internal and external customers with high degree of professionalism and discretion - Multi-tasking capability - Computer proficiency (MS Office - Word, Excel, Power Point and Internet skills), aptitude for training, capable of operating standard office equipment (e.g. fax, copier etc.). - Flexible and adaptable to a developing work environment - Fluent in local office languages and English, both written and verbal if applicable EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran). Your confidentiality and privacy are important to us. Regional, ESP Regional, Spain Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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