Technical Designer

<h2>Job Overview:</h2><ul><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Responsible for Designing CRF using leading EDC database systems</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Responsible for the preparation and /or review draft and final eCRF<span> specifications</span>, edit check specifications for assigned projects to ensure quality and consistency.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Perform all activities related to specification development for study build and design of EDC databases according to standard procedures.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Good organizational and time management skills with the ability to multi-task.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Maintain awareness of new developments in EDC vendor products which may be applied to improve the efficient use of these systems.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Responsible for performing quality control procedures for specification development.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Participate in the validation of EDC studies when requested.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Responsible for the creation and maintenance of library objects within the Global Libraries.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Responsible for the management of standard objects within the Global Libraries.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Complete work according to Labcorp drug development SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practice.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Participate in the ongoing review of the processes to ensure adaptation of best practices.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Prioritize personal workload to meet specified completion dates and perform work with minimal direction. </span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Provide feedback to management if any action is needed to increase utilization, improve efficiency, or amend the resource levels required on a project.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Provide expert guidance to project teams, external clients and internal clients within a global setting.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Perform other duties as assigned.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">University/college degree (life science, computer science, pharmacy or related subject preferred)<span> or equivalent experience</span>.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Certification in a related profession from an appropriately accredited institution (e.g., SAS certification, Programming languages / tools etc.). is an added advantage.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Broad knowledge of drug development process.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Thorough knowledge of leading EDC databases with regards to development of specifications.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Working knowledge of eCRF Design.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Working knowledge of CDISC and ICH-GCP</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Working knowledge of System Life Cycle in relationship to the implementation new applications.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Fluent in English, both written and verbal.</span></li></ul><h2>Experience:</h2><ul><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">0 - 2 years of relevant work experience to include data management and/or database programming/Designing activities. </span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Demonstrate excellent problem-solving skills, a proactive approach and the ability to make sound decisions.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Excellent oral and written communication and presentation skills.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Knowledge of clinical trial process and data management, CRF/eCRF Design, CDISC.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Demonstrated ability to work in a team environment.</span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Demonstrated ability to handle multiple competing priorities. </span></li><li style="margin: 1.0pt 0in 1.0pt .25in;"><span style="font-size: 11.0pt;">Proven interpersonal skills.</span></li></ul>