Location: Remote Experience: 10 Years Educational Qualifications BS/BA or MS in a Life Science, Computer Science, IT, Engineering, or related field, or analytical area in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation Job Purpose: This position requires the following critical abilities: Create and execute detailed test plans and UAT scripts in Excel and /or ALM testing system based on business requirements and technical specifications to verify study/library functionality in Veeva CDMS and/or Rave EDC system and adherence to standards. Drive study database user acceptance testing activities and ensure the quality of the study build in the EDC system. Ensure accurate delivery of the study build with quality deliverables per specification. Participate in the development, maintenance, and training rendered on activities around the study building and best practices used by the business. Lead UAT activities for studies and libraries in the EDC system, including inbound integrations with an Agile Approach according to applicable SOPs (standard operating procedures) and processes. Develop UAT documentation such as Test Plans, UAT Scripts, UAT Summary Report and etc. Create and execute standardized test scripts for EDC components, inbound integrations, and data listings. Record and document test results and compare to expected results. Detect software and specifications failures, so that defects may be discovered and corrected. Communicate actively with management and clinical teams about testing progress and challenges. Collaborate with cross-functional teams and vendors to ensure integration accuracy. Demonstrate strong understanding of electronic data capture and clinical data management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC systems such as Veeva CDMS and Rave, Veeva CDB, elluminate® Data Central, EHR, eCOA, IRT, RTSM, TSDV, DMR, and adjacent systems. Experience: Experience with EDC and clinical data management systems. Experience in software testing and quality assurance. Proficiency in Agile methodologies and adherence to SOPs. Understanding of clinical data management processes and regulations. Strong problem-solving skills and attention to detail. Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus. Proven track record of leading and driving business process transformation and organizational culture change, as well as delivering on programs with complex business deliverables. Show more Show less

Job Responsibilities: Review protocol and attend protocol review meetings or provide feedback, as needed. Develop eCRF specification, data validation plan, DMP, and other data management documents under the guidance and support of the lead data manager. Perform UAT under the guidance and support of the lead data manager. Provide study metrics and status reports to internal and/or client teams. Perform data cleaning activities under the guidance and support of the lead data manager. Perform SAE reconciliation activities under the guidance and support of the lead data manager. Perform external data reconciliation activities under the guidance and support of the lead data manager. Perform database lock activities under the guidance and support of the lead data manager. Assist with ongoing filing and archiving of data management documents as directed, including the filing and archiving of such documents in the TMF. Ideally, 3 plus or more years of relevant work experience, or equivalent combination of training and experience. Familiar with electronic data collection systems Preferred knowledge of data management best practices & technologies as applied to clinical trials. Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management processes.

Location: Bangalore/ Mumbai /Hybrid/WFH Experience: 3 to 6 years Job Responsibilities: Strong oral and written communication skills Study Lead Experience and exposure on efficacy domains and TFLs is a plus Participates in the creation or validation of Case Report Forms (CRFs), CRF annotations, SDTM/ADAM specifications, datasets, Define, and TLFs. Proficiency in SAS and CDISC for programming. Ensure all statistical activities are in accordance with internal and external quality standards, SOPs/WPDs, ICH-GCP, and/or other international/local regulatory requirements. Experience in specialized therapeutic areas (TAs) such as oncology, immunology, and neurology would be a plus. Core Strength: The candidate should be technically sound and have hands-on experience in Statistical Programming. Ensures excellence and high quality in work. Problem-solving approach. Act as a good team player and quick learner.