5 Clinical Trial Jobs

ZS Life Science R&D Technologist in Clinical development ZS life science R&D team partners with client to discover and develop innovative medicines that improve patient's lives. Our work spans across consulting, analytics and technology (services and platforms) projects across the several domains. We have 3500+ zs professional that are delivering R&D programs, $100MM+ invested in R&D data, analytics and technology assets and 100+ clients on R&D programs. Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in the drug development. The Drug Development R&D Technologists possess a deep understanding of technological solutions for clinical development processes including clinical study design, data management, analytics, and quality risk management platforms and products. They are well-versed in software related to clinical trial protocol design, electronic data capture (EDC), external data capture, data conformance, transformation, analysis, and reporting. Our team is well versed about industry standards such as CDISC, FHIR, OMOP, and their respective usage. Our team specializes in designing bespoke solutions or products implementation for clinical design, data management, and analytics systems. Our team has deep understanding of EDC tools like Rave, Veeva, InForm, openClinica, clinical data repositories like SAS LSAF, Oracle LSH, eCS elluminate, Metadata Repositories like Nurocor, Sycamore, Formedix, statistical computing environments like Sycamore, Domino, Sas Viya systems, Clinical data review systems, RBQM systems, and more. With experience as solution architects, business analysts, or techno-functional SMEs in GXP compliant validated environments, they guide the creation of solution, data flows and strategies for building clinical development and data management systems. Their offerings encompass technical advisory, consultancy, developing of clinical data platforms and products, system integration, and intelligent automation. Additionally, the team has created innovative tools through advanced technology and data science, aiding numerous clients in expediting the drug development process. What Youll Do You will spearhead the design & implementation of various innovative solutions in the realms of clinical trial, data management, analytics and RBQM. As a solution leader, your role will involve strategizing, offering tech consultancy, conducting assessments, and overseeing technology projects as the solution leader. You will be engaging with clients to review clinical business processes, determining requirements, establishing user narratives, and delivering solutions that have significant impact. You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time You will lead team who review and Author high-level user stories and develop related tasks, acceptance criteria and review test cases Your team will work closely with project teams in creating requirement Specifications, requirement traceability metrics , user guides and other project requirement documents You will plan and facilitate various requirement gathering, solution meetings and artefacts You will work on creating process flows based on client and internal project discussions You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Your team will act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community. What Youll Bring Bachelors degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines Masters degree in business analyst, Engineering or Science preferred. 8+ years of experience working within Life Science Domain as solution architect / business analyst / data analyst is required. Experience of working in any of Clinical trial design, data management, analytics and RBQM system development, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is required. Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required. Experience in building and delivering GxP compliant solutions for large enterprise program is required. Exposure to programming language like R, Python and SAS is preferred. Additional Skills Strong client presence and ability to communicate verbally and in writing complex domain concepts to all audiences. Significant supervisory, coaching and hands-on project management skills. Ability to manage a virtual global team environment that contributes to the overall timely delivery of multiple projects. Willingness to travel to other global offices as needed to work with client or other internal project teams. In-silico, digital twin, and/or modeling experience.

As a Clinical Research Lead with 4-10 years of experience, you will be responsible for overseeing clinical trials, documentation, research, and project management. Fluency in Japanese language is mandatory for this role. Your main tasks will include coordinating and managing clinical research projects, ensuring compliance with regulations, and collaborating with cross-functional teams. Additionally, you will be expected to communicate effectively with Japanese-speaking stakeholders, contribute to the development of clinical protocols, and provide guidance on clinical trial processes. Your expertise in clinical research methodologies and experience in the field will be crucial for the success of our projects.,

The job involves screening and enrolling volunteers according to the protocol requirements. You will be responsible for conducting ECG recordings of the volunteers, arranging and distributing first-aid boxes, and making tele-calls to the volunteers. Additionally, you will handle bio-medical waste and collaborate with the Investigator to plan and schedule volunteer enrollment and screening. Coordination with the project coordinator and Investigator is crucial to meet study requirements. You will be expected to implement and monitor Good Clinical Practice (GCP) procedures and Standard Operating Procedure (SOP) activities in the Screening group. Other responsibilities include carrying out clinical trial-related activities as necessary and mobilizing/counseling study participants for clinical studies if needed. This is a full-time position with benefits such as food provision, health insurance, leave encashment, and provident fund. The job involves working day shifts, evening shifts, Monday to Friday, night shifts, and rotational shifts. Employees also receive a yearly bonus. The work location is in-person.,

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,