Job Description Job Title: GCP Lead Employment Type: Full time Location: Bengaluru/India Experience: 5-8 Years About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Canada, the United Kingdom, Italy, Poland, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities ¢ Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation, Internal Audits, External Audits, Risk management, Innovation and Continual improvement.. Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and implementing/ monitoring them for QA function, as applicable. Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform reviews/approvals. Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for quality and compliance in pharmacovigilance. Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records. Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans. Facilitating regular CAPA status and metric reports to ensure senior management awareness. Participating in governance/oversight activities including trend assessment or other quality review. Knowledge in the area of Clinical Operations is preferred. Required Skills and competencies: Quality Assurance Nonconformance management (CAPA, Deviations, Issues) GCP Stakeholder management Conflict Resolution Problem Solving

Job Description Job Title: Senior Statistical ProgrammerEmployment Type: Full time Location: Bengaluru / RemoteExperience: 2-5 Years Primary Responsibilities Produces statistical analysis using SAS/R according to relevant standard operating procedures. Ensuring compliance to SOPs Programming analysis dataset without a specifications Delivers the assigned tasks and projects within agreed timelines and quality standards Developing SAS Programs for the statistical analysis of study data, including analysis of datasets, tables, listings, and figures Programming according to CDISC SDTM and ADaM datasets Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Create an electronic submission package to FDA, e.g., Patient Profile or Subject Narratives, ISO Listings, define.xml, or define.pdf following FDA guidelines. Preparing and performing internal training on statistical programming processes and techniques Make certain that indication or project documents and specifications are consistent and comply with company/client standards by providing the inputs into study SAP, Protocol, CRF, and outputs Provide guidance, mentoring, training for junior team members and help solve issues from cross-functional teams Represent ClinChoice/Department during internal and external audits Communicating effectively with the internal project team and global team. Collaborate closely with the study/working group. Reporting issues to the Project or Study leads or Supervisors in an appropriate time frame Responsible for continuous development of own skills according to Individual development plan. Actively present in knowledge-sharing meetings, ask questions and share feedback to improve the process or standards of the programming continuously. Proactively communicate and collaborate with the global team by understanding the time zone differences. Conducts other statistical programming activities as required Conduct other administrative and departmental activities as needed Secondary Responsibilities: Behavioral Competencies and Skills Professional Intellectual capability Trustworthy Action Orientation Personal Growth Prioritization Quality focused Active Listening Personability Willingness to learn Team Player Stress Management Learning Agility Result Driven Timely Feedback Candidate Profile Bachelors degree or equivalent required, preferably in life science, statistics, computer science, or related subjects. Should have a minimum of 4+ years of experience within the pharmaceutical industry. Good experience within the pharmaceutical industry with clinical programming and clinical development processes of across therapeutic areas. Good knowledge and experience in study setups, different processes, tasks such as SDTM, SDRG, ADaM, ADRG, TFL, ISS/ISE, Define XML, ISO Listings, Macro Programming, etc. and analysis the requirements for clinical programming projects. Good knowledge of Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology, e.g., ICH-GxP, E3, E6, etc. Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc. Good written and verbal communication skills, collaborations, and interpersonal

Primary Responsibilities. • Service Provider shall serve as the Administrator for Compliance Wire LMS for Research and Development (R&D). • Service Provider shall support Email queries related training, courses, user groups, and curriculums. • Service Provider shall create curricula, courses, offerings, Quizes and reports in the LMS and enroll learners in required and elective training. • Service Provider shall create user accounts, establish security roles, create, and assign curriculum, generate reports, and troubleshoot issues. • Service Provider shall administer qualifications, components, content objects, catalogs, and learner records in LMS. • Service Provider shall administer/maintain files to include individual (active and inactive) and group (topic-specific) trainings. • Service Provider shall administer all SOPs, and non-SOP training components, in LMS and audit for accurate version and component information. • Service Provider shall respond to all LMS work requests and all inquiries regarding training. • Add User to the LMS System upon client request and update their details. • Create Training Items into the system. Also assign the same to respective • Assign a Training item present in the system to a user or User Group upon Client • Create a curriculum of Trainings when required and add trainings to the same. • Add a user to a User Group\Curriculum to facilitate trainings.