7 Clinical Trial Jobs

Greetings from You & I Consulting! We've proudly helped candidates build careers at 64+ top MNCs across India, and were excited to bring you a new opportunity with a leading global company. If you have experience in Statistical Programming , this role is your next step forward! To Apply: Send your CV via WhatsApp or Call : Puja- (8250242229) or email your resume at :- puja@careersuni.com Shift - General Shift Open Locations :- Mumbai Pune Bangalore Hyderabad Indore Ahmedabad Key Responsibilities: Lead and oversee statistical programming activities for clinical trials at compound/indication/TA level Design and develop SDTM and ADaM datasets as per CDISC standards Generate Tables, Listings, and Figures (TFLs) for clinical study reports and regulatory submissions Manage and review deliverables for eSubmissions, including Define.xml and reviewer guides Provide technical leadership and mentorship to global programming teams Collaborate closely with biostatistics, data management, and regulatory affairs teams Support and lead Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) projects Ensure programming compliance with SOPs, FDA/EMA guidelines, and quality standards Required Qualifications: Bachelors or Masters degree in Statistics, Computer Science, or a related field 10+ years of SAS programming experience in clinical research or pharmaceutical industry Strong hands-on experience with ADaM, TFLs, eSubmissions, and integrated analysis Deep understanding of CDISC standards, regulatory compliance, and submission requirements Prior experience in oncology, neuroscience, or immunology domains preferred Proven leadership capabilities in managing cross-functional and global teams Excellent communication, project management, and problem-solving skills Preferred Tools & Skills: SAS (Base, Macro, STAT, Graph) Familiarity with SDTM/ADaM IG, FDA submission standards Understanding of regulatory submission formats (eCTD) How to Apply / Schedule an Interview: Send your details via WhatsApp or Call : Puja- (8250242229) in the following format: Full Name: Mobile Number: Email Address: Highest Qualification: Total Experience: Current Organization: Preferred Location: Current CTC: Expected CTC: Notice Period: Note: If the line is busy, please drop a WhatsApp message and we will get back to you at the earliest. Referrals Welcome! Know someone who fits the bill? Share this post and help them grow their career! You & I Consulting Your Career Growth Partner

Exp in PH II, III and IV studies Independently managing studies Manage vendors Develop study management plans, track study timelines and budget Interdepartmental coordination Required Candidate profile experience of managing clinical trials, preferably for multinational / global projects,

Hi, We are hiring for ITES Company for SAS + CDB Programmer Role. Job description: Programming, specifically J Review, SQL, R and GitHub. Good to have Python. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), EDC build and/or clinical data management experience preferred Experience in AWS preferred Experience setting up automated validation is preferred Knowledge of Data base and creating interactive Dashboards are preferred Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) Key Skills: a) Minimum 3 years of Experience in SAS CDB Programmers with R programming . b) Good to have Python knowledge c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 83

Good programming experience with various SAS functions, SAS procedures like PROC SORT, PROC PRINT, PROC MEANS, PROC CONTENTS, PROC FREQ, PROC FORMAT, PROC TRANSPOSE, PROC REPORT, PROC COMPARE, PROC IMPORT, Data set options and system Options, Data Manipulation techniques and statistical techniques. Having experience on programming techniques like reading external data files, merging the data, managing data, cleaning data, creating different outputs using SAS/ODS Expertise in analyzing clinical trial data, generating reports, tables, listings using SAS in accordance with the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs) and departmental guidelines. Having a good working experience on creating and validating Analysis datasets and SDTM datasets. Good working experience on different types of Clinical trial data like Demographic data, Adverse Events, Laboratory data, Vital Signs etc. Experience in extracting, manipulating data, and creating Data Sets from various external sources like Excel, flat files using different techniques. Extensive familiarity with CDISC-SDTM standards, Domains, SDTM Implementation Guide (3.1), and CDISC- ADaM standards.

Exp in Biologics/Biosimilar Studies Independently managing studies Manage vendors Develop study management plans, track study timelines and budget Interdepartmental coordination Required Candidate profile experience of managing clinical trials, preferably for multinational / global projects,

Good programming experience with various SAS functions, SAS procedures like PROC SORT, PROC PRINT, PROC MEANS, PROC CONTENTS, PROC FREQ, PROC FORMAT, PROC TRANSPOSE, PROC REPORT, PROC COMPARE, PROC IMPORT, Data set options and system Options, Data Manipulation techniques and statistical techniques. Having experience on programming techniques like reading external data files, merging the data, managing data, cleaning data, creating different outputs using SAS/ODS Expertise in analyzing clinical trial data, generating reports, tables, listings using SAS in accordance with the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs) and departmental guidelines. Having a good working experience on creating and validating Analysis datasets and SDTM datasets. Good working experience on different types of Clinical trial data like Demographic data, Adverse Events, Laboratory data, Vital Signs etc. Experience in extracting, manipulating data, and creating Data Sets from various external sources like Excel, flat files using different techniques. Extensive familiarity with CDISC-SDTM standards, Domains, SDTM Implementation Guide (3.1), and CDISC- ADaM standards.

The Position: (Note: This is not a role within Pharmacovigilance) The Senior Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs). Key responsibilities include collaborating closely with study team memberssuch as Data Managers, Trial Managers, and Medical Specialiststhroughout the trial process, providing timely updates on the status of medical reviews, and escalating any issues to maintain trial integrity and compliance. Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications: A graduate degree in Medicine or a related field is required (MBBS & MD in Pharmacology preferred; MBBS & MD in other clinical or paraclinical areas with relevant experience in clinical patient management or clinical research will also be considered). Preferably 3-5 years of relevant experience in Clinical Drug Development (Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, Scientific Clinical Drug Development etc). 1-2 years of project management experience is essential. Solid understanding of ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practice) principles. Proficient in computer applications, including MS Office, MS Project, and PowerPoint. Strong grasp of medical terminology and clinical trial processes. Demonstrated analytical skills with a results-oriented approach. Exceptional proficiency in written and spoken English.