EDC Developer

Job description

**EDC Developer** **Greetings from TCS!** !**!** TCS has been a great pioneer in feeding the fire of young Techies like you. We are a global leader in the technology arena and there's nothing that can stop us from growing together. Your role is of key importance, as it lays down the foundation for the entire project. Make sure you have a valid EP number before interview. To create an EP Number, please visit TCS iBegin Kindly complete the registration if you have not done it yet. P**osition: EDC Developer** Exp**erience: 2 to 12 years** L**ocation: Trivandrum** **JOB DESCRIPTIO**N * Objective / Purpose: As the EDC Developer you will work on EDC programming activities and oversee the delivery of EDC databases and documentation to support Takeda Clinical trials implementation and maintenance. You will work with Takeda study teams to develop eCRF specifications, build and/or oversee implementation of Case Report Forms (eCRFs) for clinical trials in EDC. * The EDC Developer will manage EDC system configuration, dynamic checks, edit checks, programmable protocol deviations, and integrations with EDC. * The EDC Developer operates in compliance with Takeda SOPs and processes while working with Data Management and Standards Teams to enhance existing processes. * The EDC Developer will understand Clinical Data Acquisition Standards Harmonization (CDASH) and Study Data Tabulation Model (SDTM) standards and concepts while considering EDC platform best practices. * The EDC Developer will continue developing new skills associated with EDC technologies. **Accountabilities:** * • Design, develop and validate clinical trials in EDC * • Manage edit check specifications and configure edit checks at the trial level * • Execute UAT scripts to test the setup of the clinical study or EDC Platforms * • Configure different instances of study (eg: UAT, production, testing etc.,) * • Facilitate user access requests for study teams * • Setup and manage blinded and unblinded study configurations in EDC * • Serve as SME for all EDC database related activities at the trial level * • Setup, configure, validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., * • Ability to troubleshoot database setup as per study needs * • Perform Impact Assessment for postproduction changes * • Prepare, test, and implement postproduction changes as per study needs * • Assist driving the adoption of new capabilities and business processes * • Serve as the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. * • Work with leadership to solution issues or gaps affecting the delivery of clinical trials * • Lead technology vendor oversight activities. * • Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks. * • Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents * • Participate in preparing function for submission readiness and be prepared to represent Clinical Trial Configuration group in a formal inspection or audit. * • Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. **Job Description** * • Adaptable to new ways of working using technology to accelerate clinical trial setup **Education \& Competencies (Technical and Behavioral):** * • Bachelor's degree or related experience. * • Knowledge of drug development process. * • 6 years' experience in Data Management, Clinical Programming, or other Clinical Research related fields with a minimum of 4 years' experience in EDC programming * • Hands-on experience with Veeva(mandatory), Medidata Rave, Oracle Inform, etc. * • Experience programming in CQL, CDB, working with JSON format and/or C# is preferred but not required * • Experience integrating other clinical trial modules (eg: lab, safety, IRT, coding, etc.,) with the EDC system * • Understanding of industry standard technologies to support Clinical Development needs (e.g. CTMS, SAS, R or Python, Data Warehouses, SharePoint) **Also please refer below link for downloading application form. If you don't remember your password, please click forgot password. Fill application form and then download.** TCS iBegin **Please bring all the mandatory documents below in hard copy for the interview:** **\*Latest Copy of resume** **\*TCS Application form** **\*Original and Photocopy of Government ID proof (PAN or Adhaar)** **\*Passport Size photographs - 2** **Professio**nal Skills: Strong analytical, problem‑solving, communication, and ownership mindset. TCS Eligibility Criteria: \*BE/B.tech/MCA/M.Sc./MS with minimum 3 years of relevant IT-experience post Qualification. \*Only Full-Time courses would be considered. \*Candidates who have attended TCS interview in the last 1 months need not apply. Referrals are always welcome!!! Kindly don't apply if already attended interview in last 1 months. Thanks \& Regards Amrutha