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A professional with experience in clinical trials, who understands the priority of physicians in drug supply and delivery to CT patients and critical outpatients ( outside the trial scheme). This person will need to understand the documentations necessary to support the operations and have experience within a GCP role.
This role is opened to a wide variety of profiles working in GCP. All candidates that have a strong experience with documentation management or documentation inspections within clinical trial are good particularly if they know well Protocol documentation/deviations ECD system and Alcoa-c is a plus. MCTMS, V-TMF and approving invoices understanding ( other people are doing this task but this person will coordinate)
l Principal Responsibilities:
l The person will be responsible for supporting the physicians (globally)and their patients by checking and approving the orders received via the system as well as support the internal team by checking and approving documentation.
l Responsible for communicating effectively and answering promptly to colleagues and physicians for queries regarding the local affiliates, local depots, vendors, etc.
l Be accountable for keeping track of the drug accountability in local depots, and escalating issues promptly to management when necessary
l Assuring that urgent requests are directly pick-up, by the G-CTA itself or by escalating to the GTL/TM. (inbox triage)
l Set-up of new programs in our system and update the current one in case of updates/changes to the program set-up. Reporting of patient and order numbers for specific programs.
l Assisting the GTL/TM with the creation and updating of the program documents and helping the GTL/TM with quality checks; run reports, help to solve mismatches, ect.
l Attend study management team meetings for each project and maintains documentation from meetings
l Assists in management of project budgets and Affiliate spend, reconciliation of invoices, final budget and
l liaises with Accounts payable, as necessary
l Maintains internal project specific study sites to ensure availability of all central project documents.
l Liaises with external service providers (ESP) and contract research organizations (CRO) as needed.
l Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
l With focus on quality, supports GTL, TM, GPL and Quality Assurance (QA) team with audit findings report and CAPA management
l Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, when applicable
Education and Experience Requirements:
l Bachelor’s degree or equivalent
l Degree in a health or science related field
l Excellent time management skills
l Proven ability to work independently
l Experience in clinical research experience in the pharmaceutical industry or CRO
l Literacy and proficiency in IT skills with appropriate software and company systems
l Proficiency in English
l Good organization skills, good written and verbal communication skill
l Proven ability to plan and track deliver ables and timelines
l Individual must work well in a dynamic environment and be able to prioritize and respond to changing needs of the business
Project Start Date
l June 2021
l 12 months OR maybe longer
If you are interested in the above description, please apply with your CV.
For further information, please contact Gemma Dozy at +31 (0)20 20 44 502 or by email at email@example.com