Dear Candidate, We are looking for someone with 68 years of experience in CRA, CTL, or CM roles for this position. This is an office-based job, and the location will be Ahmedabad. Working Days: Monday to Friday (Weekends off) Working Hours: 9 hours per day (Flexible timing) Role & responsibilities Responsible for end-to-end validation of CTMS and eTMF systems including system implementation, configuration change requests, periodic upgrades, Integration points with other systems (e.g., EDC) to improve the efficiency Perform periodic review and re-validation in accordance with system SOPs and sponsor-specific requirements. Conduct regular training sessions and refreshers on CTMS/eTMF systems for new hires and project teams. Provide the demo training of CTMS/eTMF systems to sponsor and internal stakeholders as applicable Responsible for user management onboarding, access provisioning, and periodic access review. Maintain access form for application user access and project specific access Develop and maintain study templates and configuration guides to standardize CTMS/eTMF use across projects. Maintain system-specific SOPs, work instructions, and validation documentation templates. Maintain and provide a support for user queries and issues. Liaise with vendor support and track resolutions for system bugs, performance issues, and configuration changes. Identify recurring operational inefficiencies and propose workflow improvements in CTMS and eTMF usage. Work with IT or software developer teams to develop auto-alerts/reminders, customize dashboards for operational oversight, data import/export but not limited too. Support vendor qualification processes for new CTMS/eTMF platforms or major upgrades as applicable. Monitor audit trail and metadata integrity within eTMF and CTMS. Ensure business continuity plans for system downtime, data recovery, and backup. Preferred candidate profile
Dear Candidate, Below are the Job Details for Clinical SAS Programmer role at CBCC Global Research LLP. Candidate should have the exposure of SDTM, ADAM and TLF. Job Location : Ahmedabad At Office Position : 2 Experience: 2-5 years in CRO preferred / Pharma industry Qualification : M. Sc. Statistics/Any Science Graduate Mandatory experience in Clinical trials Responsibilities: Ensure consistently high quality outputs for reporting and submission- 1.1. Build SAS datasets from clinical database. 1.2. Develop SAS macros, templates and utilities for data cleaning and reporting. 1.3. Utilize SDTM guidelines to build datasets. 1.4. Communicate with an internal team to create deliverables for pharmaceutical and biotechnology clients. 1.5. Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician. 1.6. Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy. 1.7. Write SAS programs to generate tables, listings, and figures and analysis datasets. 1.8. Review CRF annotations and data specifications. 1.9. Work in tandem with Biostatistics and Data Management member on various clinical projects. 1.10. Identify and edit checks per the data validation plan or data management plan. 1.11. Study management reports using SAS. 1.12. Validate the programmed analysis datasets, tables, listing and figures. 1.13. Perform analyses defined in the statistical analysis. 1.14. Prepare clinical and statistical summary reports. 1.15. Communicate with programming and statistics leads. 1.16. Utilize SAS programming skills within protocol team and perform all programming required for clinical trial analysis and reporting. 1.17. Perform quality control on final reports. 1.18. Develop SAS coding and table templates for preparing, processing and analyzing clinical data. 1.19. Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. 1.20. Provide input as required at all meetings, discussions and activities covering aspects of Statistical Reporting on project level activities. 1.21. As required, make certain that documents and specifications are consistent and comply with company standards for specifications of analysis datasets, listings, summaries, figures and tables for the clinical project 1.22. Program, according to specifications, analysis datasets, listings, tables, and figures for clinical projects and/or apply standard statistical methods to standardized PK study designs 1.23. Track milestones for project deliverables. 1.24. Maintain records for all assigned deliverables including archiving of project analysis and associated documentation. 1.25. Comply with pre-defined project / study standards and specifications. 1.26. Validate the programmed analysis datasets, tables, listing and figures. Utilize SAS programming skills within protocol team and perform all programming required for clinical trial analysis and reporting. 1.27. Develop SAS coding and table templates for preparing, processing and analysing clinical data. 1.28. Begins to develop a working knowledge of drug development and approval process 1.29. Other duties as assigned by reporting head or management Perks and Benefits Best in industry
Dear Candidate, CBCC Global Research is looking for CRA/Sr. CRA with onco PK experience for Pune location. Job Code : CBCC/IND/CRA (Please mentioned job code in subject line of your application ) Work Experience: 3-8 Years Monitoring experience with Oncology PK studies is mandatory Work Location: Pune Pre-Requisite Skills: Minimum 2 years onsite monitoring experience mandatory Patient base PK studies monitoring experience is preferred Key Responsibilities Overall site management of clinical trials and Patient base PK studies Ensure effective communication to sites Prepare for site visits Assist PM in developing the project plan Prepare the Site Activation checklist Handle back-office monitoring/centralized monitoring Coordinate with sites for resolving DCFs Other duties as assigned by PM, Head-PM, and DO Technical Experience Awareness about current regulation guidelines (GCP, NDCT rule, COVID guidance, RECIST, USFDA/EMA guidance etc.) Strong therapeutic knowledge for better handling of current studies Understanding of the ethics committee and informed consent form requirements Awareness about AE/SAE/deviations in submission and documentation requirements Awareness about phase trials, BA/BE studies and trial-related setups, instruments, staff and other site requirements Awareness about site selection requirements, aspects of (onsite/remote) monitoring, and knowledge about indication-specific good sites pan-India and handling site issues Awareness on issues during patient recruitments and the ability to effectively overcome those issues Awareness about the EDC platforms, IP handling requirement and its importance Please apply at career@cbcc.global. Important Note : Freshers are not eligible for this opening, those who are having relevant experience as mentioned above can apply for this opening .
Job Title: Associate Legal Counsel Location: Ahmedabad Department: Legal Affairs Experience Required: 4 to 6 years Job Type : Hybrid Industry Preference: Life Sciences (CRO, Pharmaceutical, Biotech, or related sectors) Role Overview: We are seeking a highly motivated and detail-oriented Associate Legal Counsel to join our team at CBCC . The selected candidate will be responsible for managing and reviewing legal documentation, ensuring regulatory compliance, and minimizing legal risks across our clinical and business operations. This role requires prior experience in legal functions within the life sciences industry , preferably in a CRO or pharmaceutical organization . Key Responsibilities: Draft, review, and amend various legal documents, including but not limited to: Confidentiality Disclosure Agreements (CDAs) Master Service Agreements (MSAs) Site Agreements Vendor Agreements Customer Contracts Ensure timely maintenance and updating of legal document trackers. Review and negotiate contractual terms with clients, vendors, and clinical trial sites to ensure alignment with company policies and legal standards. Monitor and ensure adherence to relevant laws, industry regulations, and internal policies to minimize legal and compliance risks. Collaborate with internal stakeholders (BD, Project Management, Operations, etc.) to support legal and contractual needs. Coordinate with external legal counsel on specific matters, as needed. Qualifications & Skills: Bachelors degree in Law (LL.B); LL.M is an added advantage. 4–5 years of relevant legal experience in the life sciences industry (CRO/pharma/biotech preferred). Strong knowledge of contract law and regulatory requirements in clinical research or pharmaceutical domains. Experience in drafting, negotiating, and managing a variety of legal agreements. Excellent written and verbal communication skills. Strong attention to detail and ability to work independently under tight deadlines. Proficiency in MS Office (especially Word and Excel) and document management system
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