PAREXEL International

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PAREXEL International
Miestas: Vilnius
Adresas: Kestucio g. 65/40
Telefonas: +49.30.30685.5084/+ 370 5 2113301 /8620 40065 -Gra
Faksas:
Profilio peržiūros: 2622
Įmonės aprašymas:

The expertise and passion for excellence shared by our people around the world unites us in our mission and drives our success. As one of the leading global biopharmaceutical service provider, PAREXEL has a 25 years history of delivering a full range of services and solutions through our offices in 51 countries. In fact, we have helped over 2000 top industry clients to develop and launch some of the most important drugs and devices of our time, bringing new treatments and cures to patients in need.
As a Clinical Monitoring Associate (CMA) you will have an opportunity to be a part of our well established team in Vilnius. Your main responsibility will be to perform remote clinical monitoring tasks and visits for designated projects in accordance with relevant SOPs and regulations. Responsibilities will also include managing/coordinating/supporting clinical monitoring activities remotely, including investigator / site selection, collecting regulatory documentation, drug / supply management and data collection.

Key Accountabilities:

• Perform the remote monitoring activities with a high degree of proficiency and autonomy
• Take responsibility for specific tasks on projects, or acts as the main CMA contact on individual projects
• Train team members on selected tasks
• Collaborate with CRA on site issues/actions
• Create and distribute study document (e.g. eSignature Agreement, etc.)
• Initial and on-going drug / supply management
• Responsible for the completeness and quality of the in-house site specific files
• Track system access of PAREXEL team members
• Update all relevant tracking system on an on-going basis
• Maintain team list and sponsor / vendor details
• Perform regular reviews of data according to data review/monitoring guidelines (EDMS, CTMS, CDMS/EDC, IVRS)
• Conduct remote visits (prequalification, qualification, initiation, monitoring, termination)
• Collect regulatory documents in collaboration with CRA and CTS as needed
• Primary in-house site support: on a regular basis conduct outbound and receive inbound calls to: Review recruitment plan and enrolment updates; address/resolve issues pending from the previous visit; address protocol questions; check on site staff assignment; assess drug/study supply status; request outstanding documents; review site payment status
follow-up on data entry, query status and SAEs
• Follow-up on appropriate site related questions forwarded by helpdesk
• Build relationships with investigators and site staff remotely


Essential Criteria:

• Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience
• Previous in-house monitoring experience, clinical, data management and/ or research experience with solid understanding of clinical trials methodology and terminology
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management Systems, PMED, EDC, IWRS, MS-Office products such as Excel, Word.
• Strong awareness of all relevant regulations, including GCP
• Ability to successfully work in a ‘virtual’ team environment
• Strong knowledge of clinical research process
• Sound interpersonal, oral and written communication skills
• Competent in written and oral English and relevant local languages
• Strong customer focus, ability to interact professionally within a client organization
• Attention to detail and effective time management in order to meet daily metrics or team objectives; Ability to prioritize multiple tasks and achieve project timelines
• Must be able to work independently but seek guidance when necessary, escalating issues as required

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