7 Ecoa Jobs

As a Statistical Modeller - Clinical, you will be responsible for utilizing your expertise in clinical trials and clinical data monitoring to develop and implement statistical models. Your role will involve working with Bayesian and Frequentist models, as well as handling EDC, CTMS, ePro, and eCOA systems. You will also be involved in RBQM, signal detection, KRI analysis, and outlier detection. In this position, a strong understanding of GCP ICH E6/8 and EMA Guidelines is essential. Proficiency in statistical software such as SAS, R, JMP Clinical, and Python will be required for data analysis and modelling. Experience with visualization tools like Tableau and Power BI will also be beneficial. Additionally, familiarity with project management tools like Jira and Confluence is necessary to collaborate effectively with cross-functional teams. An advanced knowledge of R, HTML, and GitHub will further support your role in this dynamic environment.,

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*). The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, you will manage, coordinate, review, and approve DM deliverables from database design & set-up, through cleaning and reporting to database locking. It is crucial to ensure that the completeness, accuracy, and consistency of clinical data meet the quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. You will also be involved in Request for Proposals (RFPs) and present at Business Development (BD) Meetings. As a Senior Clinical Data Manager I, your key tasks will include: - Leading and serving as the primary contact for DM with all relevant parties internally and externally - Planning and projecting the resources required including management of tasks, timelines, risk, and quality - Developing, reviewing, and maintaining project-specific DM documents throughout the project lifecycle - Leading and coordinating the development of clinical study database set-up, eCRF design, and database validation requirements - Creating training materials for EDC users and providing project-specific training - Overseeing data cleaning strategy, data releases, data transfers, and reconciliation activities - Providing project metric reports, status updates, study progress, and feedback to the project team - Maintaining DM study documentation, supporting internal and external audits, and aligning data management and clinical programming best practices - Participating in client evaluations, preparing new proposals and budgets for Data Management services, and staying updated on regulatory development trends Requirements: - Life science, healthcare degree and/or combination of education and experience - Minimum 5 years of relevant work experience as a Clinical Data Manager - Thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and awareness of local/regional requirements - Experience with EDC software systems, IRT, eCOA, and CDISC conventions - Strong written and verbal communication skills, organizational, negotiating, and motivational skills - Ability to work in a fast-paced challenging environment and proficiency with computer applications Benefits of working at Allucent include: - Comprehensive benefits package - Competitive salaries - Departmental Study/Training Budget for professional development - Flexible working hours and remote/office-based working opportunities - Leadership and mentoring opportunities - Internal growth opportunities, employee referral program, and access to online training platforms *This position is for the Chennai Location and not home-based** *Please note that Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.*,

Job Description for the Current running requirement of Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT). Job Title: Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT) Experience: 6+ years Location: Remote 100% Work Timing: US EST time zone Job Description: - Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT) Overview: We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies. Key Responsibilities: Author and execute test scripts in Veeva EDC , aligned with protocol requirements Validate workflows across eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms Participate in system validation (IQ/OQ/PQ, UAT) for DCT tools including handheld and remote-use devices Collaborate with clinical ops, data management, and vendors to troubleshoot issues and verify system behavior Review data capture logic and support query testing to ensure data accuracy Document test execution results, manage traceability, and support audit-readiness Contribute to ongoing improvements in test processes across DCT systems Required Experience: Strong, hands-on experience with Veeva CDMS (EDC) Working knowledge of eCOA platforms (e.g., Medidata, YPrime, Clinical Ink) Experience with IRT systems (e.g., Almac, 4G, Bioclinica) Prior involvement in DCT environments, including testing for remote or device-based workflows Understanding of clinical trial regulatory requirements (21 CFR Part 11, GxP) Detail-oriented with strong documentation and communication skills Share cv - vrani@fcsltd.com

Summary We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies. Key Responsibilities: • Author and execute test scripts in Veeva EDC, aligned with protocol requirements • Validate workflows across eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms • Participate in system validation (IQ/OQ/PQ, UAT) for DCT tools including handheld and remote-use devices • Collaborate with clinical ops, data management, and vendors to troubleshoot issues and verify system behavior • Review data capture logic and support query testing to ensure data accuracy • Document test execution results, manage traceability, and support audit-readiness • Contribute to ongoing improvements in test processes across DCT systems Required Experience: • Strong, hands-on experience with Veeva CDMS (EDC) • Working knowledge of eCOA platforms (e.g., Medidata, YPrime, Clinical Ink) • Experience with IRT systems (e.g., Almac, 4G, Bioclinica) • Prior involvement in DCT environments, including testing for remote or device-based workflows • Understanding of clinical trial regulatory requirements (21 CFR Part 11, GxP) • Detail-oriented with strong documentation and communication skills

**Urgent Hiring for the Role of Clinical Systems Specialist Veeva CDMS for our Team** Job Title: Clinical Systems Specialist Veeva CDMS Experience: 8+ years Location: Remote 100% Work Timing: US EST time zone Job Description: - Job Title: Clinical Systems Specialist Veeva CDMS Overview: We are looking for a skilled Clinical Systems Specialist with strong, hands-on experience in Veeva CDMS (EDC) . This role focuses on testing and validation within the Veeva environment and supports various modules in the Veeva CDMS suite. While deep experience with eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms is not required, you should understand how they work within decentralized clinical trials (DCTs) and be comfortable working alongside these systems. Key Responsibilities: Validate workflows within the Veeva EDC module and related components. Apply working knowledge of eCOA and IRT systems to understand clinical data flows and dependencies. Collaborate with clinical operations, data management, and vendors to troubleshoot issues and ensure systems meet requirements. Review data capture logic and perform query testing to maintain data accuracy. Document test results, maintain traceability, and ensure audit-readiness. Help improve validation processes and documentation within the Veeva CDMS environment. Required Qualifications: Strong, hands-on experience with Veeva CDMS , especially the EDC module. Familiarity with eCOA platforms (e.g., Medidata, YPrime, Clinical Ink) and IRT systems (e.g., Almac, 4G, Bioclinica) is a plus. Experience working in decentralized clinical trial (DCT) environments is highly desirable. Solid understanding of regulatory requirements ( 21 CFR Part 11 , GxP ) for clinical systems. Excellent attention to detail with strong documentation and communication skills. Ability to work effectively in cross-functional teams and with external vendors. Note: Interested candidates can drop their resumes at aagnihotri@fcsltd.com

Position: Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT) Overview: We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies. Job Description: Key Responsibilities: Author and execute test scripts in Veeva EDC, aligned with protocol requirements Validate workflows across eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms Participate in system validation (IQ/OQ/PQ, UAT) for DCT tools including handheld and remote-use devices Collaborate with clinical ops, data management, and vendors to troubleshoot issues and verify system behavior Review data capture logic and support query testing to ensure data accuracy Document test execution results, manage traceability, and support audit-readiness Contribute to ongoing improvements in test processes across DCT systems Required Experience: Strong, hands-on experience with Veeva CDMS (EDC) Working knowledge of eCOA platforms (e.g., Medidata, YPrime, Clinical Ink) Experience with IRT systems (e.g., Almac, 4G, Bioclinica) Prior involvement in DCT environments, including testing for remote or device-based workflows Understanding of clinical trial regulatory requirements (21 CFR Part 11, GxP) Detail-oriented with strong documentation and communication skills. Interested Candidate Can apply : dsingh15@fcsltd.com

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.