3 Study Startup Jobs

As a Study Start-Up Clinical Trial Manager at our office in Gurgaon, you will be an integral part of the world's largest and most comprehensive clinical research organization driven by healthcare intelligence. Collaborating with a leading pharmaceutical company, you will contribute to a 19-year partnership that focuses on advancing science in critical therapeutic areas such as cancer, cardio-metabolic, vaccines, and oncology, representing 70% of their portfolio. If you are eager to make a meaningful difference, this could be the ideal career path for you. Your responsibilities will include managing the execution and supervision of clinical trial country submissions and approvals, developing local Investigator's Brochures (ICF), overseeing country deliverables, timelines, and outcomes, as well as ensuring compliance with local regulatory and financial requirements. To excel in this role, you should possess a Bachelor's Degree along with a minimum of 7 years of extensive experience in study start-up within the CRO, pharmaceutical, or biotech industries. Proficiency in contract and budget negotiations, as well as knowledge of local submission and approval processes, are essential. Strong problem-solving abilities, effective time management skills, and adept stakeholder management capabilities are key attributes we are seeking. A positive attitude, exceptional influencing skills, and prior experience in oncology studies are also prerequisites for this position. At ICON, we believe in fostering a diverse and high-performing culture that values talent and rewards excellence. In addition to a competitive salary, we offer a comprehensive range of benefits designed to promote well-being and work-life balance for you and your family. These benefits include various annual leave entitlements, tailored health insurance options, retirement planning support, and access to a Global Employee Assistance Programme. Moreover, we provide life assurance coverage and country-specific optional benefits like childcare vouchers, subsidized gym memberships, and health assessments, among others. Join us at ICON and embark on a rewarding career where your contributions will have a meaningful impact on advancing healthcare and improving patient outcomes.,

Role & responsibilities: Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance. Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies. Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data. Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager. Perform Query Management Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities. Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle. Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness. Collaborate and work as a team to ensure the deliverables are completed on time with high quality. Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures Technical Skills: Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology Proficient with EDC and Clinical Data Management Systems Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred. Experience with RBQM methodology preferred. Exposure to CDISC guidelines and standards Preferred candidate profile: 5+ years’ experience in Clinical Data Management preferred. Bachelor’s degree in a health-related field or equivalent experience preferred. CCDM Certification preferred.

Primary Skills: 5+ years of experience in Veeva Vault Clinical (CTMS, eTMF, and/or Study Startup). 5+ years of experience in clinical trial processes and documentation workflows. 5+ years of experience in application support in GxP-regulated environments. 4+ years of experience in Vault Admin Console, security configuration, object lifecycle management. 4+ years of experience in managing support tickets using tools like ServiceNow, Jira, or Remedy. 4+ years of experience with validation (CSV or CSA) and change control procedures. 3+ years of experience managing or mentoring a small team or leading client interactions Role & responsibilities : Lead and manage the application support team for Veeva Vault Clinical modules (CTMS, eTMF, Study Startup). Coordinate end-to-end incidents, service request, and change request lifecycle in alignment with ITIL processes. Act as the primary point of contact for client stakeholders on support and release planning. Own SLA compliance, reporting, and escalation management. Guide the team through configuration changes, Vault Admin tasks, user access management, and controlled document lifecycles. Drive root cause analysis and implement preventive actions for recurring issues. Plan and execute minor enhancements and assist in major release readiness. Maintain detailed documentation for configuration, processes, and knowledge base articles. Conduct training sessions and coach team members on Veeva Vault functionalities and customer-specific workflows. Participate in release testing and validation support aligned with GxP and client SOPs.