86 Ctms Jobs - Page 2

Key Responsibilities: Lead and manage cross-functional clinical trial teams from study start-up to close-out. Develop, implement, and track study timelines, budgets, and operational plans. Ensure trials are conducted in compliance with ICH-GCP, regulatory requirements, and internal SOPs. Oversee the quality and integrity of trial data and ensure timely data entry and cleaning. Serve as the primary point of contact for internal and external stakeholders. Collaborate with vendors, CROs, and investigative sites to ensure smooth trial execution. Identify risks and develop mitigation plans to ensure study milestones are met. Review and approve study documents including protocols, CRFs, ICFs, and ...

Responsible for managing the CRIO platform, creating eSource templates, and supporting study teams with system setup, training, and compliance to ensure efficient, high-quality clinical trial execution.

About CloudLabs: 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-impa...

Role & responsibilities The role we do require is the clinical operational process/system & data expert . To be specific, the person should: - Understand key decision points within those processes - Have hands-on exposure to clinical operational technologies (CTMS, EDC, Clinical Project&Portfolio Mgmt systems, IRT etc, related workflows) - Be comfortable identifying Data Entities, Entity Attributes, and CDEs across processes - Bring strong data catalog management experience and familiarity with semantic web and ontologies to ensure knowledge is findable, reusable, interoperable, and scalable into work instructions This profile will enable the service we need: partner with business teams to a...

What you will do The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization. The AVP will lead Amgens Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases. This AVP will collaborate closely with cross-functional teams including clinical operations, ...

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 w...

Position - Clinical Operations Specialist Duration -12 months - extension based on performance CTC - up to 13 LPA Immediate joiners only Location- Hyderabad Description: Execute clinical services and meet planned deliverables in line with defined roles and re-possibilities agreed with colleagues/customers. Support set-up and maintenance of information in Clinical Trial Management Systems (CTMS) and other systems as applicable, under responsibility of COS or CPM as applicable: Update data, timelines, milestones, EC/HA authorizations, etc. on an ongoing basis. Support (Sr.) Clinical Project Manager (CPM) with study budget management, ensuring accurate planning, tracking and reporting of clinic...

Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices and International Council for Harmonization guidelines (E6(R2)) Critical thinker: Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review. Experience managing clinical content in a records management system or electronic Trial Master File system. Have strong communication skills, verbal and written. Experience Requirements: At least 3-5 year...

Roles and Responsibility Collaborate with cross-functional teams to develop and implement clinical trial protocols. Provide medical expertise and guidance on clinical research studies, including protocol development and review. Conduct site feasibility assessments and coordinate with investigators to ensure successful study execution. Develop and maintain relationships with key stakeholders, including sponsors, investigators, and regulatory agencies. Stay updated with changing regulations and guidelines governing clinical research, ensuring compliance and adherence to best practices. Participate in quality assurance activities to ensure high-quality deliverables. Job Requirements Strong unde...

What Youll Do - You will design & implement various innovative solutions in the realms of clinical trial, data management, analytics You will work in designing common data model based on clinical standards like SDTM / ADAM/ I ISS/ ISE . You will work on designing safety data mart for cross study analysis and exploratory analysis You will work on building analysis ready datasets which serves various safety and exploratory use cases across clinical trials. You have experience of building usecases like safety signal detection, reverse translation research, combination therapy exploration As a solution lead, your role will involve planning, offering tech consultancy, conducting assessments,and e...

Conduct thorough reviews of clinical trial data to ensure accuracy, completeness, and compliance with regulatory requirements. Collaborate with cross-functional teams to identify and resolve data discrepancies and issues. Develop and maintain detailed reports of findings and recommendations for data improvements. Participate in developing and implementing process improvements to enhance data quality and efficiency. Provide training and support to junior staff members on data review procedures and best practices. Stay up-to-date with changing regulations and guidelines related to clinical data management. Job Requirements Strong understanding of Good Clinical Practice (GCP) principles and reg...

Roles and Responsibility Develop high-quality regulatory documents, including clinical trial applications, marketing authorizations, and periodic safety update reports. Collaborate with cross-functional teams, including regulatory, clinical, and product development, to ensure compliance with regulatory requirements. Conduct thorough reviews of regulatory documents to ensure accuracy, completeness, and adherence to company standards. Stay up-to-date with changing regulatory requirements and industry trends to improve document quality and compliance. Provide training and guidance to junior writers on regulatory affairs and medical writing best practices. Participate in the development of new r...

Design, develop and implement solutions using ReadyWorks, Juriba, and CTMS. Integrate various IT systems and platforms to ensure seamless data flow. Automate workflows and manage IT processes efficiently. Handle data management tasks, including migration and transformation. Collaborate with cross-functional teams to deliver high-quality projects. Core Skills Proficiency in automation and scripting (Python, PowerShell, SQL, C#). Experience with system integration and cloud computing (ServiceNow, Azure, AWS, AD, RestAPI) Additional knowledge on .net, PHP, javascript, jquery is a strong booster Strong data management skills. Familiarity with project management methodologies (Agile, Scrum). Exce...

Greetings from HCL Technologie! About the Company HCL Technologies is a global technology company that helps enterprises reimagine their businesses for the digital age. Our mission is to deliver technology solutions that drive business transformation and create value for our clients. About the Role We are looking for a talented individual to join our team and contribute to our mission of delivering innovative technology solutions. Responsibilities Bachelor's degree in Life Sciences, Computer Science, or related field. 6+ years of experience in clinical data testing and validation. Perform UAT for CRF screens, database edit checks, and exceptional reports/listings. Test clinical study setup c...

Key Responsibilities: Bachelor's degree in Life Sciences, Computer Science, or related field. 8+ years of experience in clinical data testing and validation. Perform UAT for CRF screens, database edit checks, and exceptional reports/listings. Test clinical study setup configurations including protocol parameters, visit schedules, and form designs. Validate external data acquisition (Lab, ECG, PK/PD) and ensure accurate processing. Collaborate with Clinical Data Scientists and Study Data Managers to understand study scope and expectations. Strong experience with clinical study setup and CDMS platforms and CTMS Review edit check specifications; write and execute UAT scripts. Conduct QC on meta...

Role Overview: As a Business Consultant in Clinical Operations & Technology at Sonata Software, you will leverage your 8+ years of experience in the Life Sciences / Pharma domain to act as a crucial intermediary between business requirements and technological solutions for a prominent Global Pharmaceutical Company. Your primary responsibilities will involve gathering, analyzing, and documenting business needs, translating them into detailed functional specifications, and collaborating with cross-functional teams to ensure smooth implementation. Key Responsibilities: - Engage with Clinical Operations stakeholders to elicit and document business needs. - Translate requirements into clear Funct...

Role Overview: As a Business Consultant in Clinical Operations & Technology at Sonata Software, you will leverage your 8+ years of experience in the Life Sciences / Pharma domain to act as a crucial intermediary between business requirements and technological solutions for a prominent Global Pharmaceutical Company. Your primary responsibilities will entail gathering, analyzing, and documenting business needs, transforming them into detailed functional specifications, and collaborating with cross-functional teams to ensure smooth implementation. Key Responsibilities: - Engage with Clinical Operations stakeholders to extract and document business requirements effectively. - Translate requireme...

Role & responsibilities • Review clinical trial budgets and ensure they align with the financial terms in the Clinical Trial Agreement (CTA). Prepare and verify invoices based on patient visits; request refunds when needed. Record sponsor payments accurately against issued invoices. Reconcile outstanding payments and coordinate with sponsors, CROs, and study teams for resolution. Process payments for affiliate sites. Support financial closeout of clinical trials, ensuring all documentation is complete and accurate Preferred candidate profile • Education: Bachelors degree in (any Field) • Experience: o Minimum [2+] years of experience in clinical research in BPO / KPO . • Communication Skills...

Dear candidate Hiring for Top MNC Client Notice: Immediate or 10 days Location: Bangalore We are looking for a person who has experience in Veeva Vault development not an end user Job Title: Veeva Vault Application Manager-Proficient Experience Level: 10+ yrs Job Description: Mandatory Skills: *Veeva Vault , *CTMS , Quality Docs, Promo mats, RIM, eTMF, *Clinical Operations, Research & Development. Extensive knowledge on managing Quality Processes such as Deviations, CAPA, Audits, change control and Investigations. Handling Veeva features Release and Project Release activities, Impact Assessments, analyze and plan appropriate actions on data remediation/data enrichment. Own and maintenance of...

You are an experienced Veeva Vault Clinical Engineer with a minimum of 5 years of experience, seeking a full-time position in Bengaluru, India with a hybrid work model of 2 days per week in the office. Your expertise lies in CTMS, eTMF, and CDMS (EDC) within the Veeva Vault ecosystem. In this role, you will be responsible for configuring, integrating, and supporting Veeva Vault Clinical applications to enhance clinical trial systems and ensure the smooth execution of clinical operations. Your key responsibilities will include configuring and supporting Veeva Vault Clinical applications such as CTMS, eTMF, and CDMS (EDC), as well as performing system integrations, connections, and enhancement...

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. We are seeking a dynamic Manager to join our Life Sciences Consulting team, specializing in Clinical Operations transformation. This role involves working with global pharmaceutical, biotech, and medtech clients to optimize R&D and clinical delivery models, streamline operations, and implement emerging technologies across clinical developmen...

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their busines...

As a SAP Fiori/UI5 Application Developer, you will be responsible for designing and implementing SAP Fiori/UI5 applications using SAPUI5, JavaScript, HTML5, and CSS3. Your primary focus will be to ensure the responsiveness and adherence to SAP Fiori UX guidelines in all applications developed. You will be required to customize and enhance SAP Standard Fiori Apps using Business Application Studio (BAS), SAP Web IDE, Adaptation, and Extension techniques. Leveraging Smart Controls, Annotations, and CDS-based metadata-driven UIs will be essential to efficiently build Fiori applications. Experience in developing apps in BTP with Side-by-Side Extensibility is crucial for this role. In addition, yo...

Founded in 2004, MResult is a global digital solutions partner trusted by leading Fortune 500 companies in industries such as pharma & healthcare, retail, and BFSI. MResult's expertise in data and analytics, data engineering, machine learning, AI, and automation help companies streamline operations and unlock business value. As part of our team, you will collaborate with top minds in the industry to deliver cutting-edge solutions that solve real-world challenges. At MResult, you can leave your mark on projects at the world's most recognized brands, access opportunities to grow and upskill, and do your best work with the flexibility of hybrid work models. Great work is rewarded, and leaders a...

At Allucent, you will play a crucial role in helping small-medium biopharmaceutical companies navigate the world of clinical trials to deliver life-changing therapies to patients worldwide. As a Sr. Clinical Research Associate Contractor (Sr.CRA) on our remote A-team, you will have the opportunity to independently manage and monitor investigational sites, ensuring adherence to trial protocols, SOPs, regulations, and Good Clinical Practice standards. Your responsibilities will include maintaining the highest quality standards for trial monitoring activities, overseeing site activities to ensure protocol compliance, preparing detailed reports, updating CTMS systems, and providing support to th...