102 Medidata Jobs - Page 2

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Associate Manager, Clinical Data Management Responsibilities Responsibilities will include, but are not limited to Study Startup Draft EDC build timeline in collaboration with Data Management Lead. Perform DB build tasks by creating specifications for Database and Edit Checks. Create test scripts and complete test data entry/UAT for Coding, Site Payment, Safety Gateway. Collaborate with Data Management Lead and facilitate startup meetings which includes, not limited to, EDC build kick-off, Interactive eCRF Build and IRMs (Interactive Review Meeting) for database and Edit checks. Create and finalize study documents like Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP) post study team review. Ensure all startup documents are completed as per SOP and filled in eTMF as per eTMF master plan. Study Conduct Plan/execute Post Production/Migration for the study (if any). Coordinate with Clinical Data Managers for the execution of data review tasks. Coordidate with external data vendors for any escalations related to any vendor data. Support Clean Patient Group delivery along with Clinical Data Management staff. Update study documents as needed during the conduct of the study Support DML to coduct Data Quality Review meetings. Provide Data Health Metrics to Data Management Lead as requested. Study Closeout- Support Data Management Lead in planning and execution of database lock activities. Perform post lock activities, as needed. Project Management Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality. Documentation Filing of appropriate documents in eTMF as per eTMF master plan. Training and Mentorship Provide Training and mentoring to junior CDM staff. Bachelor's Degree required. Life sciences, Pharmacy or relevant fields preferred. 6 years of experience in managing end to end Clinical Data Management tasks. Able to work on end to end Clinical Data Management tasks Able to work collaboratively on multi-disciplinary project teams. Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills. Strong oral and written communication skills. Strong project management skills Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Description Sr Clinical Programmer (Spotfire/Cluepoints Prog) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. Performs system integration activities, application updates, and user acceptance testing. Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. Assists in project meetings and actively contributes and participates in departmental review meetings. Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. Manages project resources, proactively alerting management of delivery and resourcing needs. Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. Qualifications Bachelor’s degree preferred, or equivalent combination of related education and experience. 5 years of experience must have Data Visualization experience in Spotfire/Tableau/ Power BI (Useful) Experience with either Python/SQL SAS Basic OR Cluepoints experience required. Must have SAS experience Must have Clinical background experiences Preferred exp in iMedidata Rave & Veeva EDC. Good to have Spotfire API experience/knowledge. The ability to deal effectively with sponsors and internal customers at all levels. Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. Demonstrated experience in managing multiple priorities in a highly dynamic environment Experience working in a matrix-structured environment is preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. Ability to travel as necessary (up to 25%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Looking for 1 plus years experienced clinical data manager, and should be currently working in this field and be working in medidata or rave software, and be able to teach the complete workingg exposure to the students Job Type: Part-time Pay: ₹6,000.00 per month Ability to commute/relocate: Bengaluru, Karnataka: Reliably commute or planning to relocate before starting work (Required) Education: Diploma (Preferred) Experience: total work: 1 year (Preferred) Expected Start Date: 07/07/2025

Category-defining tech. Career-defining work. Lots of tech companies disrupt. But, many fail when they try to scale. We're different. CockroachDB makes it easier for companies to build and scale apps. This is how and why we're helping some of the most innovative companies on the planet. We tackle problems head-on and focus on solutions that create lasting impact. Because when our customers win, we all win. The Role Cockroach Labs is looking for passionate individuals to support our efforts to make CockroachDB cluster management a breeze for our customers as a Software Engineer, Backend (Cluster Management). This is a hands-on role where you’ll be working on a variety of technical projects related to cluster management. We are looking for creative individuals, capable of combining software and systems engineering to design, develop, cluster management solutions across various infrastructures like Kubernetes, VMs, bare metal. A successful candidate will combine the technical know-how with an empathetic and compassionate approach to engaging with the product and engineering teams across Cockroach Labs. Skills In this role, you’ll join a small but growing Cluster Management team, using your experience and skills to significantly influence the culture and product at Cockroach Labs. You will: Implement and maintain cluster management solutions for CockroachDB across different infrastructures. Work with technologies like Golang, Kubernetes and operators, Helm Charts, Terraform and more. Plan and lead cluster management projects for the CockroachDB product. Act as a subject matter expert on CockroachDB cluster management best practices. Participate in on-call rotation for Cluster Management team’s incident response process The Expectations In your first 30 days, you will become an integrated member of our engineering team. You’ll become familiar with our production systems, software development workflow, and application architecture for CockroachDB and CockroachCloud. We believe that it's essential for you to take this first month to become familiar with our technology and our company. In your second month, you’ll focus on gaining familiarity with our cluster management challenges and domain. You’ll contribute to designing our state of the art cluster management solutions for CockroachDB. In your third month, you’ll become a point person for a major cluster management feature, also helping implement or review one or more significant projects in the team. You Have The qualifications below are ideal, but not all required. We strongly encourage candidates who do not have all the qualifications listed below to apply Hands-on experience with Kubernetes or other orchestration frameworks Previous experience with developing management solutions for distributed systems or databases. 8+ years of experience in a software development role(We have multiple openings across levels). Solid understanding of computer science and systems fundamentals. Experience with tools like infrastructure management tools like helmcharts, terraform etc. The desire and capability to take a structured approach to solving large scale, complex problems The ability to take a caring and empathetic approach to relationship building and problem solving The Team BabuSrithar - Site Lead, India BabuSrithar is the Site Leader for India. He is responsible for our growth strategy and is a cultural champion in the region. He is passionate about building high-quality software products and lean teams by leveraging everyone's potential. He enjoys working with people and learning along the way. Before joining Cockroach Labs, BabuSrithar held senior leadership positions at companies like Nutanix, Clumio and recently he was VP of engineering at Apty where he led the engineering globally. When not at work, he enjoys his time with his 5-year-old and family. Isaac Wong - VP of Engineering Isaac is responsible for the health of the engineering organization at Cockroach Labs. He partners closely with teams to ensure we have a balanced culture that promotes quality and innovation in pursuit of our goals. Before joining Cockroach Labs Isaac was in life sciences for 16 years with Medidata Solutions where he had a front row seat on the exciting ride from a 30 person startup to more than 2000 people worldwide. But the lure of distributed, resilient, and consistent SQL databases, along with the amazing technology and culture at Cockroach Labs proved too much. When not working he likes to draw, play the piano, and search NYC for cannoli's with his wife and kids. Cockroach Labs is proud to be an Equal Opportunity Employer building a diverse and inclusive workforce. If you need additional accommodations to feel comfortable during your interview process, please email us at accessibility@cockroachlabs.com. Cockroach Labs has a hybrid work model, with Roachers that are local to one of our offices coming in on Mondays, Tuesdays, and Thursdays and working flexibly the rest of the week. While we’ve learned valuable lessons working remotely, nothing can replace the connection, creativity, and fun that occurs when Roachers get together and we are committed to fostering a workplace that encourages collaboration and allows us all to do our best work. Benefits Medical Insurance Flexible Time Off Paid Parental Leave Mental Wellbeing Benefits And more!

Job Title - Medidata RAVE - System Designer Location - Remote Role and Responsibility- Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP). Provide subject matter expertise to project team members during all phases of project life cycle. Develop, test, and maintain data management systems. Provide subject matter expertise prior, during and post internal and external audits and inspections. Collaborate with Data Managers, Study Teams, Vendors, and Site Staff to formulate Data Transfer plans for secondary data sources (e.g., Lab data, Site data). Batch import agreed data sources into the EDC system. Develop, program, validate, and maintain Medidata Rave EDC clinical trial databases in accordance with company standards. Create EDC design specifications encompassing the data dictionary, event definitions, electronic consent, branching logic, edit checks, advanced query rules, calculated fields, and dynamic form and event rules. Work with Data Managers and study teams to design and construct the EDC database based on global eCRF libraries. Configure and optimize multiple patient user interfaces to support varying modes of data collection (eCOA- mobile device or tablet, EDC- laptop/desktop computer). Conduct, test, and produce Rave EDC Migration activities as required. Develop test scripts and coordinate EDC user acceptance testing (UAT) to ensure accuracy of database structure, content, and validation controls aligned with the original specifications. Coordinate and manage the deployment of new or modified EDC databases into production. Assist in mapping the EDC database to the company enterprise data warehouse. As part of continuous improvement efforts, develop and implement EDC design standards to enhance quality and streamline database build proc Be available to work on any studies Work according to SOPs/WI

Looking for 1 plus years experienced clinical data manager, and should be currently working in this field and be working in medidata or rave software, and be able to teach the complete workingg exposure to the students Job Type: Part-time Pay: ₹6,000.00 per month Ability to commute/relocate: Bengaluru, Karnataka: Reliably commute or planning to relocate before starting work (Required) Education: Diploma (Preferred) Experience: total work: 1 year (Preferred) Expected Start Date: 07/07/2025

Senior Implementation Consultant Senior Implementation Consultants (SICs) help ensure that Medidata’s software applications are implemented or enabled in accordance with Medidata standard business processes, meet client requirements and adhere to Good Clinical Data Management Practices. SICs also consult with our clients, provide guidance and make suggestions on how to best implement Medidata’s software to provide the most value. Role Description & Responsibilities You will be part of the Professional Services team. You will need to prove ability to lead configuration or enablement of customers on Medidata software to translate customer needs and meet customer requirements. The candidate must have experience in setting up studies in the Rave database, including independently building Forms and Edit Checks (EC). They should also adhere to and be able to educate others on best practices for implementing Medidata’s software. The candidate must have client-facing experience and the ability to manage client interactions efficiently, ensuring smooth communication, issue resolution, and strong relationship-building. The candidate must have hands-on experience in Migration and Quick Publish activities within the Rave database. Author, adapt, or agree on specifications based upon complex client requirements. This can include functional test cases for use in configuring and developing solutions in Medidata’s suite of products, as well as in custom integrations. Support less experienced team members with client engagements, being accountable for quality of delivery. Support developers and other cross-functional departments during the configuration or implementation of specifications. Support cross-functional departments with issue resolution. Delivery of in-person/remote client workshops. Proven ability to work to Project Management timelines and budgets, ensuring timely completion of deliverables within the agreed scope of work. Proven ability to support customers during enablement or implementation of our software by answering questions, resolving configuration or UAT issues, and providing guidance on software usage. Adhere to industry data collection and handling standards to ensure consistency and facilitate downstream processing (e.g. QC testing). Communicate status reports to stakeholders on both client and internal projects. Lead internal initiatives, e.g., process improvement, product improvement, identifying best practices and developing workshop materials. Comply with and enforce Medidata Standard Operating Procedures, processes and policies. Assist in the scheduling of professional services resources and ensure timely completion of deliverables. Support Training Group in preparation of course materials and delivery of courses both internally and externally as needed. Support third party vendors with integration and/or data transfer efforts. Own multiple, complex customer facing projects or engagements. Ability to support platform implementations or enablement projects. Deep knowledge and experience in one product or solution, or, significant relevant experience in a group of products/solutions. Mentor/Train ICs, AICs or new employees. Support management in achievement of business objectives outside of client deliverables. Competencies: Expert industry knowledge of Clinical Trial processes, specifically as they relate to data collection, standards, management, and preparation for statistical analysis Strong understanding of those associated specifications, and ability to translate them into clinical systems solutions. Ability to work with technical R&D staff and translate new software features into real world examples Knowledge of computer usage in a web-based environment Ability to absorb and apply new information quickly Ability to think logically to solve complex problems Solid analytical and technical skills with regard to software applications Demonstrated strong collaboration and team-building skills Excellent verbal and written communication skills Strong organizational and time management skills Self-motivated, able to assume responsibility and work autonomously in a professional manner Experience of working to Standard Operating Procedures Highly adaptable to changing business needs and product landscapes, maintaining a positive outlook and inspiring/motivating others Willing to travel to office locations and customer engagements Qualifications Bachelor’s or Master’s degree in Life Sciences or a related Clinical Domain 4 to 10 years of experience in clinical data management with Rave Study Setup activities/Rave Programming Strong client-facing experience Good communication skills What’s In It For You Work in an environment that fosters teamwork, creativity, and continuous learning. Explore opportunities for professional development and career progression within a dynamic and supportive team Engage with a diverse range of customers and coworkers, solving real business challenges rather than just low-level development tasks. Work on cutting-edge technologies, products, and solutions that make a difference in the clinical research space Inclusion statement As a game-changer in sustainable technology and innovation, Dassault Systèmes is striving to build more inclusive and diverse teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, it’s our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future.

Saama - Technical Project Manager - JD Reports to: Program Manager Job Description ❖ Required / Must Have Skills ➢ Strong project management skills, including planning, execution, and risk management. ➢ Excellent communication and interpersonal skills, with the ability to effectively communicate with technical and non-technical audiences. ➢ Proven ability to lead and motivate cross-functional teams. ➢ Technical background or understanding of the technologies involved in the project. ➢ Minimum of 10 years of hands-on experience in Application programming. ➢ Ability to adapt to changing priorities and manage multiple projects simultaneously. ➢ Strong analytical, problem solving, troubleshooting & debugging skills. ➢ Knowledge on Python (otherwise Java or DotNet), SQL, Data Engineering, Data Analytics tools, AWS, etc. ❖ Good to have skills ➢ Good understanding of one or more of the following Clinical Systems EDC Systems such as Medidata Rave, Veeva EDC, Oracle Clinical, Medrio, InForm, etc., CTMS Systems such as Siebel CTMS, Medidata CTMS,Veeva CTMS, etc., IRT Systems such as YPRIME, Parexel Clinphone, etc., LAB Systems such as central Lab, local Labs etc., ➢ Good understanding of clinical trial domain & overall EDC study setup & reporting process.

Premier Research is looking for a Data Coordinator - DM to join our Clinical Data Sciences team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. What You'll Be Doing Assists in testing of databases (DBs) and maintenance of study data, including the processing of discrepancies and queries. Reviews Case Report Forms (CRFs), data listings, and DBs to ensure that all captured data follow the rules outlined by the protocol, CRF Completion Guidelines (CCGs) and departmental plans. Collaborates cross-functionally with colleagues to ensure the integrity of clinical databases. Prepares documentation, such as CCGs, Data Management Plan (DMP), Data Report Assists in developing standard test data for testing screens and listings and provides feedback on the results of the testing Performs user acceptance testing on studies, including testing of edit checks, etc. Assists in maintaining DBs and supports DB updates Performs data entry Generates reports for data review Reviews CRFs, data listings, and DBs to ensure all data captured follow protocol, CCGs, DMP, etc. Generates queries to appropriate internal or external personnel (e.g., investigational sites, Clinical Research Associates and client representatives) to resolve problematic data identified during various aspects of the data management (DM) process Reviews responses to queries and resolves discrepancies Performs external data and/or serious adverse event reconciliation Acts as a Lead Data Coordinator and/or Safety Reviewer on multiple studies Performs document submission to Trial Master File (TMF) Supports TMF Quality Control (QC) activities Performs database QC activities Performs QC of study reports, CRF archive files Supports the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, project status What We Are Looking For Bachelor’s Degree or above (preferably in a Life Science) Typically requires 2 -4 years of DM mastery or related clinical research industry experience Knowledge of at least one Clinical Data Management System (CDMS) (e.g. Medidata Rave, Calyx EDC, etc.)

Description Saama - Technical Project Manager - JD Reports to: Program Manager Job Description ❖ Required / Must Have Skills Strong project management skills, including planning, execution, and risk management. Excellent communication and interpersonal skills, with the ability to effectively communicate with technical and non-technical audiences. Proven ability to lead and motivate cross-functional teams. Technical background or understanding of the technologies involved in the project. Minimum of 10 years of hands-on experience in Application programming. Ability to adapt to changing priorities and manage multiple projects simultaneously. Strong analytical, problem solving, troubleshooting & debugging skills. Knowledge on Python (otherwise Java or DotNet), SQL, Data Engineering, Data Analytics tools, AWS, etc. ❖ Good to have skills Good understanding of one or more of the following Clinical Systems ■ EDC Systems such as Medidata Rave, Veeva EDC, Oracle Clinical, Medrio, InForm, etc., ■ CTMS Systems such as Siebel CTMS, Medidata CTMS,Veeva CTMS, etc., ■ IRT Systems such as YPRIME, Parexel Clinphone, etc., ■ LAB Systems such as central Lab, local Labs etc., Good understanding of clinical trial domain & overall EDC study setup & reporting process.

Premier Research is looking for a Associate Data Manager - FS (4 month fixed-term contract) to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. What We Are Searching For: Assists in preparing clean databases by performing a review of clinical trial data through the CDMS or external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan Provide input to and review of Data Management Plans in support of clinical study deliverables Generates queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates, and client representatives) to resolve problematic data identified during every aspect of the data management process Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies the database accordingly Supports the development of CRFs and edit check specifications per protocol and participates in user acceptance testing of CRFs and associated edit check specifications as required Assists in the user acceptance testing for study-specific data listings ensuring data output adheres with requirements Prepares and maintains documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required What We Are Searching For: Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience 3 to 5 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions. Demonstrates excellent English verbal and written communication skills Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc) Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities

Role: Clinical Operations Business Consultant Required Technical Skill Set: Highly skilled with Veeva eTMF Application Experience: 5+ Yr Work Location: Mumbai, New Delhi, Indore, Bangalore, Hyderabad, Pune, Lucknow, Chennai, Kolkata Desired Competencies (Technical/Behavioral Competency) Must-Have: Experience with R&D specific IT application systems for Document management, trial management, Data management and/or Pharmacovigilance. Experience with data visualization and/or analytics tools and ability to build, program and modify new reports and visualizations. Experience with Clinical Trial related systems, e.g. Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF, preferably Veeva Vault), Electronic Data Capture (EDC, preferably Medidata RAVE) and Large Scale Data Analytics (such as SpotFire, CluePoints, JReview or similar). Highly proficient in Information Technology systems, including Microsoft Office suite. Proven record of working inside a team with different colleagues in any position, including being in the Lead. Being able to tailor feedback on compliance to different levels in the organization from Assistant roles to executive VP levels and in between. Knowledge of statistical methods and being able to apply that to detect outliers in data sets and/or to create thresholds such as Quality Tolerance Limits (QTLs) as required by ICH E6 (GCP) is a strong preference. Strong preference for candidates with a Project Management certificate and/or proven experience in project management for R&D related projects. Strong analytic skills for large quantities of compliance, risk management and clinical data. Strong interest in Pharmaceutical Development, mainly in the clinical research (R&D) aspects of drug development. Good-to-Have: Veeva Vault admin certification is required Experience with Veeva RIM Connectors is preferred Regulatory Information Management: Manage the lifecycle of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM. Ensure that regulatory submissions comply with applicable local and international regulations and guidelines. Maintain and update regulatory documentation, including registration dossiers, variation applications, and compliance documents. System Configuration and Maintenance: Configure and customize Veeva Vault RIM to meet organizational needs, ensuring it aligns with regulatory requirements and workflows. Monitor system performance, troubleshoot issues, and coordinate with Veeva support for resolution. Data Management: Ensure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones. Implement data governance practices to maintain compliance and quality of regulatory data. Cross-Functional Collaboration: Collaborate with various teams, including Regulatory Affairs, Quality Assurance, Clinical Development, and Pharmacovigilance, to ensure timely and accurate regulatory submissions. Act as a point of contact for regulatory queries and provide training to internal teams on Veeva RIM functionalities. Regulatory Compliance: Stay updated on regulatory changes and ensure that the organization’s processes and systems comply with current regulations and industry best practices. Participate in audits and inspections as necessary, providing documentation and system access as required. Responsibility of / Expectations from the Role: Should be able to manage Regulatory information management VEEVA RIM & eTMF Demonstrated practical working experience in both processes (eg.xEVMPD) and untilisation of regulatory systems (RIMS, VEEVA) Handle Regulatory Affairs business processes Regulatory Information management VEEVA Vault RIM Align with Support Team on current issues and initiate problem management. Prepare and update application related documentation (Operational Instructions, User Manuals). Processes (eg.xEVMPD) and systems (eg.RIMS, VEEVA) Results-driven and pragmatic approach to work Good organizational skills, self-motivated and proactive Meticulous working style and high attitude to quality.

Job Requirements Responsibilities Primary owner of testing activities from planning through test execution Maintain and improve mobile and web test suites for patient-facing applications. Work closely with all members of the Product and DevOps teams – designers, technical architects, integration Analyst, AWS engineers, site reliability engineers, analysts, Digital and operational leadership - to execute on the product vision. Maintain high standards of software quality within the team by establishing good practices and habits. From understanding of new product requirements through acceptance criteria and wireframes, create new test cases and integrate them into existing regression suites. Create a high visibility traceability matrix for new feature development. Assist the product teams with issue management and quality trends reporting. Assist with the creation of reports, manuals, and other documentation on the operation and maintenance of products. Assist with the analysis and resolution of application problems. Assess opportunities for application and process improvement. Provide second-level support for issue investigation and resolution. Serve as the advocate for the user experience. Own and drive the frontend and backend automation of our application platform, considering future product roadmap The production, test, and product release activities such as document/process creation, review and approval of batch records and associated documents. Also, product release and transactions. Drive and uphold high engineering standards and practices, bringing consistency to the codebases you encounter and ensuring software is adequately reviewed, tested, and integrated. Requirements: 5+ years minimum of Experience as a software Automation Quality Assurance analyst. 5 years minimum Experience with a Test automation tool. Experience with automation tools like Selenium or MABL would be a huge plus. 5 years minimum Experience with a Test Management tool. 5 years minimum Experience with Agile SDLC. Experience creating and managing a product Traceability Matrix. Experience with Jira for issue documentation and management. Experience with test driven development. Experience with various testing strategies and methodologies and strong understanding of when to apply those different strategies. Strong judgment, with the ability to distill and communicate the true impacts of issues. Strong attention to detail. Analytical mindset with an interest in how digital solutions work. Ability to break complex and complicated issues down to root causes. Comfortable articulating and fighting for application quality during high-pressure release cycles. Understanding data standardization practices in pharma domain, integrating Healthcare data, and security related to HIPAA is a plus. Experience with Medidata EDC would be a huge plus Qualification Degree in computer science, information technology, or related field. Minimum of 5+ years of hands-on experience in test qualification and productionizing high performing and scalable services involving high volume of data processing within a software product development environment, preferably in life science industry Self-motivated with a passion for learning, analyzing technology tradeoffs, and shipping product

CloudLabs Inc was founded in 2014 with the mission to provide exceptional IT & Business consulting services at a competitive price, to help clients realize the best value from their investments. Within a short span, CloudLabs evolved from pure-play consulting into a transformative partner for Business Acceleration Advisory, Transformative Application Development & Managed Services - enabling digital transformations, M&A transitions, Automation & Process-driven optimizations & complex Integration initiatives for enterprises across the globe. As a Strategic Planning & Implementation Partner for global companies, CloudLabs has seen a 200% uptake in winning high-value, high-impact and high-risk projects that are critical for the business. With offices in the US, Canada, Australia & India and with the team of 150+ experienced specialists, CloudLabs is now at an inflection point and ready for its next curve of progress. Please write/follow us here: Website: cloudlabsit.com LinkedIn: CloudLabs Inc E-Mail: info@cloudlabsit.com What we offer: We welcome candidates rejoining the workforce after career break/parental leave and support their journey to reacclimatize too corporate. Flexible remote work. Competitive pay package. Attractive policy, medical insurance benefits, industry leading trainings. Opportunity to work remotely is available. Job description: We're seeking an experienced Medidata Rave(EDC) Study Designer to support delivering strategic initiatives supporting the Global Clinical IT team. In this role, the individual will be supporting business initiatives within Medidata Rave suites of applications. This individual should have demonstrated prior experience as a member of an Agile team and be highly motivated with excellent analysis and execution skills. Duties and Responsibilities Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP). Provide subject matter expertise to project team members during all phases of project life cycle. Develop, test, and maintain data management systems. Provide subject matter expertise prior, during and post internal and external audits and inspections. Collaborate with Data Managers, Study Teams, Vendors, and Site Staff to formulate Data Transfer plans for secondary data sources (e.g., Lab data, Site data). Batch import agreed data sources into the EDC system. Develop, program, validate, and maintain Medidata Rave EDC clinical trial databases in accordance with company standards. Create EDC design specifications encompassing the data dictionary, event definitions, electronic consent, branching logic, edit checks, advanced query rules, calculated fields, and dynamic form and event rules. Work with Data Managers and study teams to design and construct the EDC database based on global eCRF libraries. Configure and optimize multiple patient user interfaces to support varying modes of data collection (eCOA- mobile device or tablet, EDC- laptop/desktop computer). Conduct, test, and produce Rave EDC Migration activities as required. Develop test scripts and coordinate EDC user acceptance testing (UAT) to ensure accuracy of database structure, content, and validation controls aligned with the original specifications. Coordinate and manage the deployment of new or modified EDC databases into production. Assist in mapping the EDC database to the company enterprise data warehouse. As part of continuous improvement efforts, develop and implement EDC design standards to enhance quality and streamline database build processes. Provide input into the development and revision of department SOPs. Maintain compliance with corporate, core and study-specific learning requirements. Experience with Medidata Custom Functions (C#/SQL) would be preferred. Preferred Qualifications Bachelor 's Degree in related field. 5+ years of experience developing, supporting, and maintaining healthcare systems. Prior experience with EDC system (Medidata Rave, Expert) Medidata Rave EDC Certified Study Builder certification is highly preferred Prior experience with MEDS reporter, SQL Advanced system analysis skills and experience with EDC technologies such as (iMedidata, architect modules, reporting modules). Demonstrated experience in systems analysis, SDLC, change management, and requirements gathering. Experience requirement: Minimum 5 years of relevant experience. Location: India only. Job type: Remote.

Job Summary CDM: 6 yrs of minimum Clinical Data Management experience Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases. Rave (Medidata) or Veeva EDC hands on experience is must. Must Have: Setup experience should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory). Conduct Experience Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc . Study Lock Freezing/Locking, should have good experience of Study lock Client facing role and Mentoring are added advantage. 1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 2 Participate in innovation and process improvement initiatives. 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required. 6 Study Setup hands on experience. 7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication

Jd Cdm 3 yrs of minimum Clinical Data Management experience Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases. Rave (Medidata) or Veeva EDC hands on experience is must. Must Have Setup experience should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory). Conduct Experience Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc . Study Lock Freezing/Locking, should have good experience of Study lock Client facing role and Mentoring are added advantage. 1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 2 Participate in innovation and process improvement initiatives. 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required. 6 Study Setup hands on experience. 7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication

Jd Cdm 3 yrs of minimum Clinical Data Management experience Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases. Rave (Medidata) or Veeva EDC hands on experience is must. Must Have Setup experience should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory). Conduct Experience Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc . Study Lock Freezing/Locking, should have good experience of Study lock Client facing role and Mentoring are added advantage. 1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 2 Participate in innovation and process improvement initiatives. 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required. 6 Study Setup hands on experience. 7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication

ROLE: Data Quality System Testing Expert (FSP) DURATION: 12 + month Contract, probable extension LOCATION: FULLY REMOTE (India) Candidates only INTERVIEW: MS TEAMS conversation 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 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

Job Summary CDM 6 yrs of minimum Clinical Data Management experience Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases. Rave (Medidata) or Veeva EDC hands on experience is must. Must Have Setup experience should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory). Conduct Experience Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc . Study Lock Freezing/Locking, should have good experience of Study lock Client facing role and Mentoring are added advantage. 1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 2 Participate in innovation and process improvement initiatives. 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required. 6 Study Setup hands on experience. 7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication

Jd Cdm 2 to 3 yrs of minimum Clinical Data Management experience Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases. Rave (Medidata) or Veeva EDC hands on experience is must. Must Have Setup experience should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory). Conduct Experience Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc . Study Lock Freezing/Locking, should have good experience of Study lock Client facing role and Mentoring are added advantage. 1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 2 Participate in innovation and process improvement initiatives. 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required. 6 Study Setup hands on experience. 7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication)

Jd Cdm 4 - 6 yrs of minimum Clinical Data Management experience Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases. Rave (Medidata) or Veeva EDC hands on experience is must. Must Have Setup experience should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory). Conduct Experience Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc . Study Lock Freezing/Locking, should have good experience of Study lock Client facing role and Mentoring are added advantage. 1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 2 Participate in innovation and process improvement initiatives. 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required. 6 Study Setup hands on experience. 7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication

Premier Research is looking for a Associate Database Developer (Fixed Term Contract) - India to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. Responsible for the configuration of project databases, tools, and utilities using Clinical Data Management Systems (CDMS) and underlying database platforms for the purposes of capturing accurate clinical trial data. What You'll Be Doing Creates electronic Case Report Forms (eCRFs) according to finalized protocols and study design specifications for Electronic Data Capture (EDC) studies Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies Communicate with data management and study management teams throughout all study start up activities to ensure team needs are understood and met. Designs, builds, and tests clinical databases according to Standard Operating Procedures (SOPs) Programs field derivations, edit checks, consistency checks, validations, procedures and rules. Writes data extraction programs Develops of study reporting environment which includes CRF and non-CRF (loaded) data in addition to transforming collected data to required reporting format. Ensures database documentation is maintained for the Trial Master File (TMF) Works in collaboration with the sponsor and study team to define all technical elements of the Data Management Plan What We Are Searching For Bachelor's degree, or international equivalent from an accredited institution, preferably in a technical field, or equivalent combination of education, training and experience 0 to 3 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions. 1 to 2 years of SQL programming experience preferred Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Demonstrates excellent English verbal and written communication skills Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities Familiarity with drug development and clinical trial processes preferred

Job Description T+S no h1 must have LinkedIn 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

Position Overview: We are seeking a highly qualified and experienced Director Clinical Research to lead and oversee clinical trials and research initiatives within our organization. The ideal candidate will have strong expertise in clinical research, particularly in oncology, and possess a deep understanding of global clinical trial regulations, study design, and execution. This role requires strategic thinking, team leadership, and the ability to manage multiple concurrent research projects in a fast-paced environment. Key Responsibilities: Leadership & Strategy: o Lead and oversee all clinical research activities, ensuring alignment with organizational goals and regulatory requirements. o Develop and implement clinical trial strategies, including protocol design, study planning, and risk mitigation. o Provide mentorship and guidance to clinical research teams and collaborators. Clinical Trial Management: o Oversee the planning, initiation, execution, and close-out of clinical trials. o Ensure compliance with FDA regulations, ICH GCP guidelines, and applicable local regulations. o Coordinate with CROs, investigators, and site staff for study implementation and monitoring. Regulatory & Compliance: o Prepare and review clinical protocols, Investigator Brochures (IBs), informed consent forms, and regulatory submissions. o Ensure ethical and regulatory compliance throughout all research activities. Data Analysis & Reporting: o Collaborate with biostatisticians and data managers to analyze clinical data. o Interpret study results and oversee preparation of study reports, publications, and regulatory documentation. Stakeholder Engagement: o Liaise with cross-functional departments including medical affairs, pharmacovigilance, and R&D. o Represent the organization in scientific meetings, regulatory discussions, and industry forums. Desired Candidate Profile: Educational Background: o Ph.D., MD, or MPH in a relevant scientific field such as biology, medicine, pharmacology, pharmacy, or public health. Experience: o Minimum 5-10 years of progressive experience in clinical research, with a strong track record in managing trials from concept to completion. o Prior experience in oncology research is highly preferred. o Experience working with global clinical trial regulations, particularly FDA and ICH GCP. Skills & Knowledge: o Excellent knowledge of clinical trial design, regulatory pathways, and protocol development. o Proficiency in statistical software (e.g., SAS, SPSS, R), data management tools (e.g., Medidata, Oracle Clinical), and relevant e-clinical systems. o Strong communication, leadership, and problem-solving skills. o Ability to work collaboratively in a cross-functional environment. Key Competencies: Strategic thinking and project leadership Clinical compliance and operational excellence Scientific acumen and data interpretation Team mentoring and stakeholder management Attention to ethical and quality standards

Job Title: Director – Clinical Research Location: Greater Noida Experience Required: 5–10 Years in Clinical Research Educational Qualification: Ph.D., MD, or MPH (or equivalent) in a relevant scientific discipline (e.g., Biology, Medicine, Pharmacy) Budgeted CTC: Upto ₹36 LPA Employment Type: Full-Time | Onsite About the University: Our Client is a NAAC A+ accredited, multidisciplinary university in Greater Noida that fosters global learning, cutting-edge research, and innovation. With over 20,000 students from 85+ countries, the university is one of India’s leading education providers with a focus on holistic and interdisciplinary education. Position Overview: We are seeking a highly qualified and experienced Director – Clinical Research to lead and oversee clinical trials and research initiatives within our organization. The ideal candidate will have strong expertise in clinical research, particularly in oncology , and possess a deep understanding of global clinical trial regulations, study design, and execution. This role requires strategic thinking, team leadership, and the ability to manage multiple concurrent research projects in a fast-paced environment. Key Responsibilities: Leadership & Strategy: Lead and oversee all clinical research activities, ensuring alignment with organizational goals and regulatory requirements. Develop and implement clinical trial strategies, including protocol design, study planning, and risk mitigation. Provide mentorship and guidance to clinical research teams and collaborators. Clinical Trial Management: Oversee the planning, initiation, execution, and close-out of clinical trials. Ensure compliance with FDA regulations, ICH GCP guidelines, and applicable local regulations. Coordinate with CROs, investigators, and site staff for study implementation and monitoring. Regulatory & Compliance: Prepare and review clinical protocols, Investigator Brochures (IBs), informed consent forms, and regulatory submissions. Ensure ethical and regulatory compliance throughout all research activities. Data Analysis & Reporting: Collaborate with biostatisticians and data managers to analyze clinical data. Interpret study results and oversee preparation of study reports, publications, and regulatory documentation. Stakeholder Engagement: Liaise with cross-functional departments including medical affairs, pharmacovigilance, and R&D. Represent the organization in scientific meetings, regulatory discussions, and industry forums. Desired Candidate Profile: Educational Background: Ph.D., MD, or MPH in a relevant scientific field such as biology, medicine, pharmacology, pharmacy, or public health. Experience: Minimum 5–10 years of progressive experience in clinical research, with a strong track record in managing trials from concept to completion. Prior experience in oncology research is highly preferred. Experience working with global clinical trial regulations, particularly FDA and ICH GCP. Skills & Knowledge: Excellent knowledge of clinical trial design, regulatory pathways, and protocol development. Proficiency in statistical software (e.g., SAS, SPSS, R), data management tools (e.g., Medidata, Oracle Clinical), and relevant e-clinical systems. Strong communication, leadership, and problem-solving skills. Ability to work collaboratively in a cross-functional environment. Key Competencies: Strategic thinking and project leadership Clinical compliance and operational excellence Scientific acumen and data interpretation Team mentoring and stakeholder management Attention to ethical and quality standards Application Process: Interested candidates may send their updated CV and a brief statement of clinical leadership experience to: [connect@coral-ridge.com] | Subject Line: Application for Director – Clinical Research Shortlisted candidates will be contacted for an in-depth discussion and final round of interaction. Job Types: Full-time, Permanent Pay: ₹3,000,000.00 - ₹4,000,000.00 per year