3 Edc Systems Jobs

Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Study build and Edit check development Programming Languages Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline with 9+ years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CROs, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related discipline Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Manager, CSAR - Electronic Data Interchange and Acquisition Role Description The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical Reporting, focusing on Electronic Data Interchange/Acquisition programming activities. This role involves developing the Data Acquisition Requirements Specification (DARS) document to outline metadata transfer requirements, establish and validate vendor integration criteria, and manage the processing of electronic data from vendors. The position requires cross-functional collaboration to ensure high-quality deliverables, support clinical systems, and oversee electronic data capture technologies. The Manager, CSAR will be responsible for study-level and portfolio-level quality and deliverables while also contributing to large system transformation projects with project management, subject matter expertise, partner engagement, and change management responsibilities. A strong leadership mindset and ability to influence partners is essential, along with individual contribution to study-specific and general CSAR/Global Development Operations projects. Responsibilities Support clinical trial platform technologies and ensure smooth operations. Enable data-driven decision-making by providing analytical insights. Coordinate and provide programming support to Clinical Study Teams. Collaborate with Clinical Data Management to meet study deliverables and timelines. Act as a technical point of contact for systems deliverables on defined programs. Develop the DARS document, specifying metadata transfer requirements. Set up and test RWS integration requirements, supporting study closure with final data loads and transfer discontinuation. Configure data upload gateways between external vendors and Amgen. Provide technical and business process expertise on new and emerging technologies. Develop, review, and implement policies, SOPs, and associated documents. Assist in preparing for and responding to audit findings (internal or external). Basic Qualifications Bachelor's degree in Life Sciences, Computer Science, Business Administration, or related field with 9-13 years of experience. Proven experience in managing teams. Specialist knowledge/experience in Life Sciences or a medically related field. General biopharmaceutical clinical research experience (clinical trial experience at biotech, pharmaceutical, or CROs). Preferred Qualifications Advanced degree or equivalent in Life Science, Computer Science, Math, Statistics, Business Administration, or a related field with 9-13 years of experience. Broad knowledge/work experience in data management/programming in the pharmaceutical or biotech industry. Proven experience in managing teams. Project management and planning experience. Experience overseeing outside vendors (CROs, central labs, imaging vendors, IRT vendors, etc.). Must-Have Skills Good Clinical Practice. Expertise in performance management techniques, measures, problem-solving, and analytical thinking. Understanding of drug development and clinical trial processes. Data management processes. Clinical trial database programming and applications. Experience collecting, maintaining, and supporting data cleaning controls for external (non-EDC) data. Proficiency in importing clinical study data from central labs and imaging vendors. Knowledge of the systems development lifecycle. Programming languages expertise. Project planning and management. Ability to collaborate with global cross-functional teams (team/matrix environment). Quality management and risk analysis. Regulatory filings and inspections expertise. Process improvement methodologies. Soft Skills Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills.

Contribute to design, develop and implement High complex projects or initiatives that are part of clinical programming roadmap Provide technical expertise, cross training and support as required to ensure the availability and performance of developed reports and dashboards for end users Contribute to defining and building vital processes and tools to perform clinical programming activities for both global and study level analytical solutions Contributes to development of best practices that enhances quality, efficiency, timelines and effectiveness within the function Access as an SME for CP tasks and Processes ,identifies and communicates risk within assigned studies and/or projects Collaborates with various teams including data management, development operations, clinical, biometrics and other relevant cross functional teams supporting clinical trials to deliver end user reporting needs Ensures high quality is built into own deliverables and quality delivered by other programmers BachelorS/Master degree or equivalent in computer science, life science or statistics Accomplished programming skills in SAS/Python/SQL/R. Experience in producing analytical dashboards with Power BI, Spotfire or other Business Intelligence tools. Thorough knowledge of Data Collection and industry standards Technical expertise with data capture, data models, data mining. Excellent analytical and critical thinking skills, writing, communication skills, and ability to work within a cross functional team Prior Experience in understanding of EDC systems like Medidata Rave or Veeva etcSenior Clinical Programmer is primarily responsible for activities related to programming, dashboard development and validation of data cleaning and review listings and complex programs for ongoing clinical studies. This position requires high technical skills and adequate industry knowledge to independently perform programming tasks while using judgement about seeking guidance in complex situations and also contribute to cross-functional initiatives with high complexity.Programming : Python/SAS/SQL Data Visualization and Analytics skills : MicroStrategy POWERBI or other BI tools Tools(Desirable) : Exposure towards Saama/ SAS LSAF Domain (Desirable): High understanding of Clinical Trail Life Cycle and Data Management including TPV exposure Others : Exposure towards Project and Stakeholder Management