86 Ctms Jobs

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations.Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Minimum 2 years of experience in regulatory medical writing or a related field. Strong knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Minimum 2 years of experience in regulatory writing, preferably in the pharmaceutical or biotechnology industry. Strong understanding of regulatory requirements,

Collaborate with cross-functional teams to develop and implement clinical research studies. Provide medical expertise and guidance on study design, methodology, and statistical analysis. Develop and maintain relationships with key stakeholders Required Candidate profile Strong understanding of clinical research principles, methodologies, and regulations. Excellent communication and interpersonal skills, with the ability to work effectively with diverse stakeholders.

As an experienced SAP Fiori/UI5 Developer, your role will involve designing and implementing SAP Fiori/UI5 applications using SAPUI5, JavaScript, HTML5, and CSS3. Your primary focus will be on ensuring the responsiveness and adherence to SAP Fiori UX guidelines. You will also have the opportunity to customize and enhance SAP Standard Fiori Apps using tools like Business Application Studio (BAS), SAP Web IDE, and Adaptation and Extension techniques. Key Responsibilities: - Leverage Smart Controls, Annotations, and CDS-based metadata-driven UIs to efficiently build Fiori applications. - Experience in developing apps in BTP with Side-by-Side Extensibility. - Configure SAP Fiori Launchpad & Buil...

Role Overview: MResult, a global digital solutions partner established in 2004, collaborates with top Fortune 500 companies across industries like pharma & healthcare, retail, and BFSI. Specializing in data, analytics, machine learning, AI, and automation, MResult assists companies in enhancing operations and unlocking business value. As a Veeva Solution Architect at MResult, you will play a crucial role in empowering clients with data-driven insights and innovative digital solutions, contributing to real-world challenges and growth opportunities. Key Responsibilities: - Utilize your 7+ years of experience in life sciences IT to provide hands-on expertise in Veeva Vault Clinical, CTMS, eTMF,...

Project Role : Business Analyst Project Role Description : Analyze an organization and design its processes and systems, assessing the business model and its integration with technology. Assess current state, identify customer requirements, and define the future state and/or business solution. Research, gather and synthesize information. Must have skills : Business Requirements Analysis, Life Sciences, Clinical BA, Regulatory / RIM BA Good to have skills : NA Minimum 7.5 Year(s) Of Experience Is Required Educational Qualification : 15 years full time education Summary: As a Business Analyst, you will engage in a variety of tasks that involve analyzing an organization and designing its proces...

As a Clinical Project Manager, you will be responsible for overseeing clinical trials with a focus on interventional studies (Phase IIV). Your key responsibilities will include: - Directly managing and operationalizing clinical trial protocols into eSource/EDC workflows. - Managing end-to-end clinical trial processes such as start-up, site initiation, data collection, query management, and close-out. - Leading and mentoring CDM/clinical trial teams with a minimum of 5 years of people management experience. - Utilizing expertise in clinical trial systems like CTMS (CRIO preferred), eSource, and EDC platforms. - Working in pharmaceutical, biotechnology, or CRO environments across various thera...

About The Role Project Role Business Analyst Project Role Description Analyze an organization and design its processes and systems, assessing the business model and its integration with technology. Assess current state, identify customer requirements, and define the future state and/or business solution. Research, gather and synthesize information. Must have skills Business Requirements Analysis, Life Sciences, Life Sciences Clinical BA, Life sciences Regulatory BA Good to have skills NA Minimum 5 year(s) of experience is required Educational Qualification 15 years full time education Summary As a Business Analyst, you will engage in a variety of tasks that involve analyzing an organization ...

About The Role Project Role Application Developer Project Role Description Design, build and configure applications to meet business process and application requirements. Must have skills Veeva Vault Good to have skills NA Minimum 2 year(s) of experience is required Educational Qualification 15 years full time education Summary As an Application Developer, candidate will have hands-on experience in designing, developing, and implementing Veeva Vault solutions and knowledge on integrations with other systems. This role requires a deep understanding of Veeva Vault architecture and the ability to provide technical leadership. Your typical day will involve collaborating with team members to unde...

Position Overview The Regulatory Specialist II supports the planning, preparation, and maintenance of essential regulatorydocumentation required for clinical research studies This role ensures compliance with federal, state, and local regulations, as well as internal policies and procedures The Regulatory Specialist II collaborates closely with Operations, Quality, and Compliance teams to ensure all regulatory activities are completed accurately and on schedule Key Responsibilities Prepare, submit, and maintain IRB submissions, including initial, continuing review, amendment, promptly reportable event, and closure documents Maintain electronic Investigator Site Files (eISF), ensuring essenti...

The Data Surveillance Analyst (DSA) is responsible for analyzing scientific and operational data to support the Data Surveillance process and reviewing project-specific Quality Tolerance Limits. They assist in developing Data Surveillance Plans (DSPs) and conduct defined project reviews. The DSA also attends internal and external Data Surveillance meetings, where they present relevant findings to the project team. Key Accountabilities Data Surveillance Plan Development and Technology Configuration: Support the development of a robust Data Surveillance Plan, including Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis Configure and Maintain Data Surveillance techn...

Job title : Team Lead - Registry Projects ( Regional Project Lead) Hiring Manager: Group Lead Study Management Location: Hyderabad % of travel expected: Travel required as per business need Job type: Permanent and Full time About The Job Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions . Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. The Sanofi Business Operations is buil...

Role Overview: ZS is a management consulting and technology firm that focuses on transforming ideas into impact by utilizing data, science, technology, and human ingenuity to deliver better outcomes for clients worldwide. As a part of ZS, you will work alongside a collective of thinkers and experts to create life-changing solutions for patients, caregivers, and consumers. Your role will involve designing and implementing innovative solutions in clinical trials, data management, and analytics. Additionally, you will lead technology projects, collaborate with clients, and contribute to the growth of a Business Analysis community. Key Responsibilities: - Design and implement innovative solution...

As an Application Specialist Senior - Veeva, your role involves supporting the day-to-day operations of Clinical Systems/ IT applications with GxP categorization. Your responsibilities include ensuring optimal system performance, managing system enhancements, resolving L2/L3 tickets, and mentoring Application Analysts for L1 ticket resolution. Additionally, you will provide training and technical support to clinical users, Application Analysts, and contribute to the review and maintenance of processes, tools, and standards. **Key Responsibilities:** - Provide L2/L3 support for clinical (CTMS, eTMF & Vault Safety) & IT systems with GxP categorization as per company defined SLA's in different ...

Job Description JOB TITLE Project Manager REPORTING TO Nikita Bathla LOCATION New Delhi/Remote OPEN ENDED / FIXED TERM (Duration) Two-year appointment, extendable based on performance and institutional opportunities. FULLTIME EQUIVALENT 2.0 JOB FAMILY Projects CAREER STEP Independent About The George Institute We are a medical research institute affiliated with leading universities aiming to challenge the status quo in health care. With 700+ people around the world, and projects in over 40 countries, our Strategy 2025 is all about impact - specifically, the impact of The George Institute's activities on the health of millions of people, particularly those living in disadvantaged circumstance...

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Data Surveillance Analyst (DSA) is responsible for analyzing scientific and operational data to support the Data Surveillance process and reviewing pro...

Job Summary We are seeking a highly skilled and proactive Veeva CTMS Subject Matter Expert (SME) to join our consulting firm and support our Life Sciences clients in optimizing clinical trial management processes. This role will be responsible for managing Veeva CTMS, eTMF, EDC implementations, ensuring compliance, and enabling efficient trial lifecycle management for our clients. Key Responsibilities Act as the subject matter expert (SME) for Veeva CTMS, eTMF, and EDC across our Life Sciences consulting projects. Lead end-to-end configuration of Veeva CTMS, eTMF, and EDC to support clinical trial planning, execution, data management, and reporting for various clients. Manage stakeholder rel...

Job Summary We are seeking a highly skilled and proactive Veeva CTMS Subject Matter Expert (SME) to join our consulting firm and support our Life Sciences clients in optimizing clinical trial management processes. This role will be responsible for managing Veeva CTMS, eTMF, EDC implementations, ensuring compliance, and enabling efficient trial lifecycle management for our clients. Key Responsibilities Act as the subject matter expert (SME) for Veeva CTMS, eTMF, and EDC across our Life Sciences consulting projects. Lead end-to-end configuration of Veeva CTMS, eTMF, and EDC to support clinical trial planning, execution, data management, and reporting for various clients. Manage stakeholder rel...

Databriks + Pyspark About The Role ::1 Skill:Databriks + Pyspark Exp 5 to 8 yr Location Any PSL , Bangalore, Delhi, Pune , Chennai Dont look for Hyderabad Location Azure Data bricks,PySpark,Oracle PL SQL,ETL,SQL,Data Integration Data Engineer - Data AnalystSummaryStrategically manages and maintains corporate global clinical data for all major business units, while ensuring data quality and integrity. Provides system support, testing, and training for applications accessing clinical data.Proven 2-5 years work experience as a Data Analyst in Clinical data Identifies, investigates, and resolves data quality issues, communicating with business units and IT and performing root cause analysis as n...

Project Role : Business Analyst Project Role Description : Analyze an organization and design its processes and systems, assessing the business model and its integration with technology. Assess current state, identify customer requirements, and define the future state and/or business solution. Research, gather and synthesize information. Must have skills : Business Requirements Analysis Good to have skills : NA Minimum 5 Year(s) Of Experience Is Required Educational Qualification : 15 years full time education Summary: As a Business Analyst, you will analyze an organization and design its processes and systems, assessing the business model and its integration with technology. Your typical da...

Main responsibilities: The Regional Project Leader (RPL) is responsible for the regional oversight on start-up and follow up activities as well as project oversight of the CPL and CRA within the region for the Rare Disease Registries in close collaboration with the Global Operations Lead Rare Disease Registries and Medical Affairs staff in the countries. The RPL has responsibility for rare disease registries according to Company and Sponsor Standard Operating Procedures, and local regulatory guidelines. This position will ensure timely support for the below activities in consultation with the Global Operations Lead Rare Disease Registries and Medical Affairs staff. 1. Project Management: Res...

Databriks + Pyspark About The Role 1 Skill:Databriks + Pyspark Exp 5 to 8 yr Location Any PSL , Bangalore, Delhi, Pune , Chennai Dont look for Hyderabad Location Azure Data bricks,PySpark,Oracle PL SQL,ETL,SQL,Data Integration Data Engineer - Data AnalystSummaryStrategically manages and maintains corporate global clinical data for all major business units, while ensuring data quality and integrity. Provides system support, testing, and training for applications accessing clinical data.Proven 2-5 years work experience as a Data Analyst in Clinical data Identifies, investigates, and resolves data quality issues, communicating with business units and IT and performing root cause analysis as nec...

• 3 to 8 years of IT experience with at least 2 to 4 years of hands-on experience in Veeva Vault support. • Strong knowledge of Veeva Vault platform and modules (Quality, Clinical, RIM, PromoMats, or Safety). • Hands-on experience in Vault administration, configuration, and security management. • Expertise in incident, problem, and change management processes (ITIL framework). • Familiarity with APIs, web services, and integration troubleshooting. • Good understanding of Life Sciences processes (Clinical, Regulatory, Quality, and Commercial). • Proficiency in SQL, reporting, and log analysis for issue debugging. • Experience with system validation and compliance requirements. Preferred Skill...

You are an experienced Veeva Configuration Specialist sought for a position in Chennai by Themesoft. Ideal candidates should possess Veeva certification. The role involves working with Veeva Vault Configurations, VQL, and related tasks in the life sciences sector. **Key Responsibilities:** - Acquire 5-12 years of experience in the life sciences sector with a focus on Veeva Vault Configurations for any Vault. - Execute implementation, support, and administration of Veeva Vault platform for various suites like CTMS, QMS, Safety, eTMF, etc. - Define and implement global business processes for safety. - Possess a thorough understanding of international regulations and associated business process...

Hi We have immediate job opening with our client for Across Location on Remote. Please find the JD Exp : 5 - 9yrs (relevant exp) Key Responsibilities: Lead and manage shift operations for a team of 1015 SAP Basis consultants Deliver SAP Basis support across S/4HANA, Business Suite, EWM , and associated landscapes Perform system monitoring, performance tuning, transport management (ChaRM/CTMS) Handle data growth analysis, security updates, deletion/partitioning, system refreshes, and upgrades Manage SAP HANA , including performance optimization and troubleshooting across ERP, BW, BW4HANA Drive incident and change management in line with ITIL practices Create and maintain shift rosters, ensure...