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Local Trial Manager - Oferta z Jobs.pl

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Local Trial Manager

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  • inVentiv Health -Transforming Promising Ideas into Commercial Reality Job Title: Local Trial Manager (ref 5255) Primary Function: inVentiv Health is looking for new and enthusiastic colleagues to join our Strategic Resourcing team. This means you will be employed by inVentiv Health with all benefits, but solely be working for one of our clients, one of the world's leading pharmaceutical companies. The Local Trial Manager (LTM) is locally responsible for the trial management and the primary point of contact at country level. The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements. For this position we are looking for candidates located in The Netherlands or Belgium. Job Description: Typical activities of the Local Trial Manager would include: * Responsibility for country do-ability and site feasibility and selecting the final site list * Contributions to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at country level * Leading and coordinating local trial team activities * Ensuring that all SAEs/PQCs are reported within reporting timelines * Monitoring country progress and initiating corrective and preventive actions * May lead negotiation of trial site contracts and budgets * Attending and participating in Investigator Meetings * Conducting local trial team meetings and providing CRA training * Reviewing and approving Monitoring Visit Reports * Reviewing and approving site and local vendor invoices * Working with the CRAs to ensure readiness for audits and quality related visits * Acting as local expert for assigned protocols * Establishing and maintaining excellent working relationships with external and internal stakeholders * Actively contributing to process improvement; training and mentoring of CTAs and CRAs. Application Details If you would be happy to join the team, please contact us, so that we can tell you more about what our organization has to offer. You can contact Irene or Eveline on with reference to number 5255 and we are looking forward to get to know you over a cup of coffee. We do offer a nice package of benefits, including car allowance, low employee costs on pension and paid health care insurance. But, very important, career development within inVentiv Health is not just two words, but core within the company. If this role is not suitable for your experience but you have worked in clinical research in the industry and would like to discuss other roles, please contact us as well for other possibilities! inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients' therapies to market.


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