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.
Job Summary: We are seeking a detail-oriented and proactive Operations Manager to oversee the day-to-day operations of our Clinical SAS Programming team. This role is critical in ensuring the timely delivery of programming outputs, optimizing team workflows, and supporting cross-functional collaboration across clinical development, biostatistics, and data management. Key Responsibilities: Operational Oversight Manage timelines, resource allocation, and deliverables for clinical programming projects. Track progress against milestones and proactively address risks or delays. Ensure compliance with regulatory standards (CDISC, FDA, ICH-GCP). Team Coordination Facilitate communication between programmers, statisticians, and data managers. Support onboarding, training, and performance tracking of programming staff. Promote a culture of accountability, collaboration, and continuous improvement. Process & Quality Management Implement and maintain SOPs, workflows, and documentation standards. Drive automation and efficiency improvements in programming operations. Monitor quality metrics and ensure audit readiness. Stakeholder Engagement Serve as the point of contact for operational updates to leadership and project teams. Coordinate with global teams to align on priorities and resource needs. Support strategic planning and capacity forecasting. Qualifications: Education & Experience Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related field. 7+ years of experience in clinical SAS programming, with 2+ years in a leadership or operations role. Job Summary: We are seeking a detail-oriented and proactive Operations Manager to oversee the day-to-day operations of our Clinical SAS Programming team. This role is critical in ensuring the timely delivery of programming outputs, optimizing team workflows, and supporting cross-functional collaboration across clinical development, biostatistics, and data management. Key Responsibilities: Operational Oversight Manage timelines, resource allocation, and deliverables for clinical programming projects. Track progress against milestones and proactively address risks or delays. Ensure compliance with regulatory standards (CDISC, FDA, ICH-GCP). Team Coordination Facilitate communication between programmers, statisticians, and data managers. Support onboarding, training, and performance tracking of programming staff. Promote a culture of accountability, collaboration, and continuous improvement. Process & Quality Management Implement and maintain SOPs, workflows, and documentation standards. Drive automation and efficiency improvements in programming operations. Monitor quality metrics and ensure audit readiness. Stakeholder Engagement Serve as the point of contact for operational updates to leadership and project teams. Coordinate with global teams to align on priorities and resource needs. Support strategic planning and capacity forecasting. Qualifications: Education & Experience Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related field. 7+ years of experience in clinical SAS programming, with 2+ years in a leadership or operations role. Skills & Competencies Good understanding of clinical trial processes and CDISC standards (SDTM, ADaM). Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira). Excellent organizational, communication, and problem-solving skills. Ability to manage multiple priorities in a fast-paced environment. Preferred Qualifications: PMP or similar project management certification. Experience working in a CRO or pharmaceutical company. Familiarity with regulatory submission processes (e.g., eCTD, define.xml). Good understanding of clinical trial processes and CDISC standards (SDTM, ADaM). Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira). Excellent organizational, communication, and problem-solving skills. Ability to manage multiple priorities in a fast-paced environment. Preferred Qualifications: PMP or similar project management certification. Experience working in a CRO or pharmaceutical company. Familiarity with regulatory submission processes (e.g., eCTD, define.xml).
Location: Bangalore/ Mumbai /Remote (WFH) Experience: 5+ years Job Responsibilities: Strong oral and written communication skills Experience in handling complex efficacy domains and TFLs Act as subject matter expert for large-scale complex projects, providing hands-on support for the completion of projects. Solve critical technical problems. Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM/ADAM specifications, datasets, and TLFs. Ensures excellence and high quality in the programming of analysis-ready datasets, tables, listings, and figures for which they are responsible. Provide support to mentor and train junior team members. Ensure all statistical activities are in accordance with internal and external quality standards, SOPs/WPDs, ICH-GCP, and/or other international/local regulatory requirements. Proficiency in SAS and CDISC for programming, as well as programming management skills for the project leader role. 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. Responsible for appropriate code reviews and ensuring quality checks are performed on deliverables. Issues would be raised about timelines, deliverables, and quality directly, and he/she would be the key communicator in resolving problems at a team level. Providing support for onboarding additional programmers and mentoring them. *Relevant industry experience is mandatory. Freshers may kindly refrain from applying.
Clinical Data Validation Specialist - Elluminate experience Location: Bangalore/ Mumbai /Remote (WFH) Experience: 2+ years Job Responsibilities: Develop and implement data cleaning and reporting solutions to ensure quality and timely delivery of study data, metrics, and visualizations as per data review plans. Create and maintain documentation for all reporting deliverables throughout the study lifecycle. Build a library of reusable data checks in collaboration with data engineers and configuration specialists. Partner with cross-functional teams to define business rules and establish an automated check library across therapeutic areas. Ensure compliance with SOPs and work practices. Act as a technical resource in developing data analytics for data validation and cleaning. Support knowledge sharing and training on reporting tools to ensure data accuracy and integrity. Provide programming expertise to enhance data quality and create tools, macros, and libraries for efficient data review. Develop and test data review listings and maintain operational excellence through collaboration with clinical data management and medical reviewers. Drive innovation and process improvement in reporting and data management practices. Core Strength: Bachelor’s degree in computer science, Statistics, Biostatistics, Mathematics, Biology, or a related health field, or equivalent experience. Good understanding of the drug development process and regulatory data standards (CDISC, SDTM preferred). Minimum 2 plus years of experience in developing programming listings and visualizations using tools such as Veeva CDB, JReview, or Elluminate ( Elluminate experience preferred). Proficient in programming languages such as CQL, SQL, SAS, R, or Python. Familiar with clinical database systems (e.g., Metadata Rave, Veeva, InForm). Skilled in using Microsoft Office tools (Word, Excel, Outlook). Strong understanding of clinical trial terminology. Able to work independently in a fast-paced environment, demonstrating initiative and adherence to deadlines.