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Clinical Trials Implementation Manager

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IT/Technical & Product Development
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Elsevier
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CLI000KM Requisition #
Elsevier is the leading provider of science and health information. We partner with experts around the globe to develop world-class content, delivering it in ways that fuel discovery, drive innovation, and improve health care.  MACRO is an advanced clinical trial data collection solution used to support clinical trials units, disease-specific research groups, commercial pharmaceutical companies and charitable organizations.

Elsevier is looking for a talented, customer focused and service driven individual, with a strong technical background and experience of delivering large-scale clinical technology implementation projects. This person is passionate about driving success for our customers through the rollout of innovative products. This role includes all responsibilities for implementation activities such as on-boarding, technical integration work, data migration services,  clinical trial eCRF design, training and technical support services.

The MACRO Implementation Manager assumes a leadership role in MACRO implementation projects. He/she will deliver client-facing technical solutions, from design, development, delivery, installation, validation and training. They will be experienced at working to required clinical trial regulations and legislation, including GCP guidelines, to develop and deliver clinical trial eCRFs programming solutions according to customer specification. They will capture customer pain points and implement solutions based on his/her deep understanding of the customer and clinical data capture domain. He/she will prioritize and communicate production customer issues and defects based on relevant data for timely resolution and also lead the demo to key stakeholders at program milestones. The successful candidate will also provide input and assistance to testing and customer support teams.

The  MACRO Implementation Manager will take responsibility for the planning, development and supervision of the external customer-facing MACRO hosting environments.  Working closely with the MACRO commercial team, the role will ensure that any changes and updates to supported MACRO platforms are regulatory compliant, appropriately documented and support the increased efficiency of the external environment.

The MACRO product is developed and supported in a regulated, safety critical environments and is subject to external audits and government inspections. The MACRO Implementation Manager is directly responsible for ensuring that MACRO services are delivered according to the Quality Management System (QMS), in accordance with the Quality charter.

Elsevier is a world-leading provider of information solutions and analytics that enhance the performance of science, health, and technology professionals, empowering them to make better decisions, deliver better care, and sometimes make ground-breaking discoveries, that advance the boundaries of knowledge and human progress.
Educated to degree-level, preferably with a background in IT,  health care clinical research or bioinformatics.

 
Previous Experience of dealing directly with customers in a technical environment, particularly of managing implementation projects in a clinical research/ practice/pharma/safety critical environment.
In depth understanding of clinical trial regulatory compliance of processes and issues.

 

 

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