Clinical Document Specialist II
1 week ago
About the role: As a Clinical Document Specialist II, you will be responsible for checking the quality of indexed documents in the eTMF and ensure they are filed correctly, with accurate metadata applied to each document. Occasionally, you may be assigned for more detailed eTMF quality review to ensure the eTMF is inspection ready. This role requires attention to detail, understanding of regulations surrounding TMF management, sponsor expectations, inspection readiness and strong sense of timeline management. In addition to that knowledge of global IRBs and Regulatory authorities and their requirements is expected. The role is strongly supported by line manager and a dedicated learning and development team that helps nurture your capabilities and succeed in your role. Do you think you have what it takes to be a Clinical Document Specialist II? Check the role description below: Responsibilities: Review documents in the workflow to finalize the indexing of the documents. Ensure to sustain & improve quality thresholds and meet daily productivity goals as defined in organization SOPs. Identify mis-filings and provide feedback to the indexing team, also to ensure the mis- filings are not repeated. Answer Q&As in project rooms and ensure they are completed within timelines. Drive efficient and effective communication with all stakeholders. Coordinate with Clinical Document Team Leads for project related queries, keeping various project documentation up to date and in line with client expectations. Perform internal reviews of assigned eTMFs and take corrective action as required for audit readiness. Assist with User Acceptance Testing during product development and release. Required Qualifications, Skills and Experience: Knowledge of clinical development phases and processes including GCP and ICH regulations. Superior written and spoken communication skills in English. Proficiency in Microsoft Office (Word, Excel, Outlook), and knowledge of eClinical technologies. Proficiency in Document Management (Adobe professional, knowledge of scanning an advantage, document Indexing, using ISI Tools and Capture Perfect) Minimum Bachelor's Degree from a 4-year college or equivalent. Minimum of 2.5 years of experience in the Life Sciences industry; Experience with essential documents and other study documentation. Experience with clinical trials at research sites, IRB submissions, pharmacovigilance is a plus. Desired Skills and Experience: Previous employment in Pharmaceutical, CRO, Medical Device or Investigative Site. Able to multitask in a fast-paced environment. Work seamlessly with people from a variety of different backgrounds and cultures. Build trust relationships with clients and co-workers alike. Can work independently and as part of a team. Take proactive measures to solve problems and commit to a high level of service. Work Time : 9:30 AM - 6:30 PM (General Shift) *Work from Office is mandatory Location - Aundh, Pune
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Clinical Document Specialist I
1 week ago
Pune, Maharashtra, India TransPerfect Full timeDo you work in clinical research and would like to explore more about different functionalities within this industry? Never known TMF management could be a career option and want to know more? Do you want to expand your horizon and learn something more than you currently know? Do you want to learn from the experts and apply your knowledge in your day to day...
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Clinical Document Specialist I
4 weeks ago
Pune, Maharashtra, India TransPerfect Full timeDo you work in clinical research and would like to explore more about different functionalities within this industry?Never known TMF management could be a career option and want to know more?Do you want to expand your horizon and learn something more than you currently know?Do you want to learn from the experts and apply your knowledge in your day to day...
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Clinical Trial Manager II
3 weeks ago
Pune, Maharashtra, India Lifelancer Full timeJob Title: Clinical Trial Manager II Job Location: India Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level DescriptionClinical Trial Manager II (Client Base)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical,...
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Pune, Maharashtra, India Dizzaroo Pvt Ltd Full timeType: Full-TimeExperience Level: Experience working with global study start up either in Medical writing/Regulatory or Project management functionAbout UsDizzaroo is a pioneering startup at the intersection of AI and pharma/biotechnology, redefining how advanced technologies can revolutionize advances in drug development.Job OverviewWe are seeking...
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Pune, Maharashtra, India Dizzaroo Pvt Ltd Full timeType: Full-TimeExperience Level: Experience working with global study start up either in Medical writing/Regulatory or Project management functionAbout UsDizzaroo is a pioneering startup at the intersection of AI and pharma/biotechnology, redefining how advanced technologies can revolutionize advances in drug development.Job OverviewWe are seeking...
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cra ii
3 weeks ago
Pune, Maharashtra, India Lifelancer Full timeJob Title: CRA II Job Location: India Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level DescriptionClinical Research Associate IISyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial...
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Biostatistician II FSP
2 weeks ago
Pune, Maharashtra, India Lifelancer Full timeJob Title: Biostatistician II FSP Job Location: India Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Job DescriptionWho Are You? A Biostatistician II with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support Phase I-IV clinical studies. You are...
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Senior Clinical Safety Specialist
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Clinical Safety Specialist
7 days ago
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Documentation Specialist
24 hours ago
Pune, Maharashtra, India Pivotal Full timePivotal is looking for an experienced Documentation Specialist to join our team. As a Documentation Specialist, you will be responsible for creating and maintaining accurate and up-to-date technical documentation for our software products.About the JobThe ideal candidate will have strong organizational and multitasking abilities, with the ability to...
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Clinical Trial Management Specialist
4 days ago
Pune, Maharashtra, India Roche Full timeAbout the CompanyRoche is a pioneer in the biotechnology industry, with a rich history spanning over 125 years. We've grown into one of the world's leading research-focused healthcare groups, with a global presence in 100 countries. Our commitment to innovation has led us to develop cutting-edge technologies that have transformed the practice of medicine. As...
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Clinical Trials Management Specialist
4 days ago
Pune, Maharashtra, India Roche Full timeYour ResponsibilitiesLead cross-functional experts to deliver a particular solution with a good understanding of the business requirementsTake leadership, coordinate and act as a subject matter expert for Veeva Vaults Clinical, Regulatory, Quality Management, and Quality DocumentsEnsure cost-effectiveness, scalability, and security in all aspects of the...
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Senior Documentation Specialist
16 hours ago
Pune, Maharashtra, India Pivotal Full timePivotal is seeking a highly skilled Senior Documentation Specialist to join our team. As a key member of our Technical Publishing Team, you will be responsible for creating and maintaining high-quality technical documentation for our software products.The ideal candidate will have 8 years of experience in technical writing for software products or technology...
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Documentation Specialist
6 days ago
Pune, Maharashtra, India Ubique Systems Full timeJob OverviewUbique Systems is seeking a highly skilled Documentation Specialist to create comprehensive technical documentation for our products and services. This role requires strong collaboration, communication, and problem-solving skills, as well as expertise in content development tools like Madcap Flare and Confluence.Main Responsibilities:Develop and...
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DLS Clinical Consultant
3 weeks ago
Pune, Maharashtra, India ADCI PNQ 13 SEZ Full timeAt Amazon we believe that every day is still day one and we are working to be the Earth's Best Employer. To get there, we need exceptionally talented, bright, and driven people. If you'd like to be a part of Disability Leave Services (DLS) Clinical team to provide your clinical expertise for leave of absence, disability and accommodation services to Amazon...
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Document Management Specialist
1 day ago
Pune, Maharashtra, India Diensten Tech Limited Full time**About Diensten Tech Limited**We are a dynamic company looking for a highly skilled Lead Document Control Specialist to manage and organize our company documents.Key Responsibilities:Manage and maintain accurate document records.Evaluate and implement effective document control procedures to ensure compliance.Collaborate with teams to meet documentation...
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Compliance Document Specialist
6 days ago
Pune, Maharashtra, India Diensten Tech Limited Full timeCompany OverviewDiensten Tech Limited is a leading provider of innovative solutions. Our mission is to deliver exceptional results while maintaining the highest standards of quality and compliance.We are looking for a highly skilled Lead Document Control Specialist to join our team and take on the challenge of managing and organizing company documents.The...
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DHF Documentation Specialist
3 days ago
Pune, Maharashtra, India BOSTON SCIENTIFIC Full timeWe're seeking a DHF Documentation Specialist to join our team at Boston Scientific. In this role, you'll be responsible for providing mechanical engineering support in the maintenance of project DHF deliverables.QualificationsMechanical Engineering degree (B.E. or B.Tech) with 8-10 years of experiencePreferred experience in management of DHF documentation...
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Administrative Document Specialist
1 day ago
Pune, Maharashtra, India SNC Lavalin Fayez Engineering Full timeSNC Lavalin Fayez Engineering is seeking a highly organized and detail-oriented Administrative Document Specialist to join our team. As a key member of our organization, you will be responsible for managing and controlling documentation for various projects.About the RoleThe successful candidate will have solid experience in document control and management,...
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Lead Document Control Specialist
7 days ago
Pune, Maharashtra, India Diensten Tech Limited Full timeJob DescriptionDiensten Tech Limited is looking for Lead Document Control Specialist to join our dynamic team and embark on a rewarding career journeyManage and organize company documentsEnsure compliance with document control proceduresMaintain and update document records accuratelyCoordinate with teams for documentation needs