Precision for Medicine, Oncology & Rare Disease is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.
You will develop and manage clinical databases and applications including, but not limited to RAVE, Datatrak, Medrio, and Inform. Additionally, you will play a lead role in internal software projects that require specialized programming and/or scripting.
* You are flexible in providing input and guidance when designing clinical databases * You consistently receive positive feedback on your training approach from end users and junior staff * You thrive in a fast paced environment without diluting the quality of your work * You pride yourself on designing and maintaining validation documents * You are well sought after to conduct demonstrations and software trainings sessions * You are passionate about improving the lives of cancer patients
What to expect day to day:
* Maintain the full-scope of responsibility for assigned projects ensuring on-time delivery, communicating the status of projects to internal teams and study * Developing, testing, and validating programs and clinical databases supporting projects and applications * Assisting in development, system administration and/or advanced technical support services for internally developed applications and clinical databases, client-related projects and third-party applications * Providing data management support for client-related projects from CRF design to post database close and archival * Participating in software vendor selection * Participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities * Performs all duties in accordance with SOPs, government regulations, guidelines and industry standard
* Bachelors and/or a combination of related experience
* 12 years of experience in a clinical, scientific or healthcare discipline * Experience in Object Oriented Programming (C#, C++, VBS, etc.…), scripting language (PERL, etc..), SAS, R, SQL * Experience in development and utilization of clinical database management systems * RAVE custom function programming experience * Broad knowledge of drug, device and/or biologic development and effective data management practices * Able to handle a variety of clinical research tasks * Proficient with Microsoft Office Suite * Proven teamwork skills and flexibility, excellent verbal/written interpersonal skills and positive attitude
* Oncology and/or Orphan Drug therapeutic experience * Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) * Base SAS®, SAS/STAT and SAS/ACCESS software
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