Clinical Research Associate/Senior Clinical Study Manager

1 day ago


Mumbai, Maharashtra, India KlinEra Global Services Full time
Job Overview
KlinEra Global Services is a leading provider of innovative clinical trial and research services. As a Clinical Research Associate/Senior Clinical Study Manager, you will play a vital role in ensuring the success of our studies.

About the Role
The ideal candidate will have extensive experience in oncology trials, with a strong understanding of Indian regulations and their practical implementation. You will be responsible for conducting site qualification visits, initiation visits, interim monitoring visits, and close-out visits to ensure compliance with GCP and ICH guidelines. Additionally, you will review source data and case report forms for accuracy, completeness, and integrity, and identify and resolve ongoing data issues.

Duties and Responsibilities
- Conduct remote and on-site monitoring visits to ensure compliance with protocol requirements
- Review and report on site recruitment efforts, enrollment metrics, and serious adverse events
- Identify and resolve data discrepancies and perform data queries and listings
- Oversee the transmission of study data according to protocol-specified timelines
- Maintain consistent contact with study site staff, including investigators, coordinators, and other individuals involved in the clinical study
- Timely visit report writing and site correspondence

Requirements
- Extensive Phase I, II, and III experience in oncology trials
- Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
- Flexibility with changing priorities
- Ability to efficiently perform and prioritize multiple tasks
- Computer proficiency in Microsoft Word, Excel, and PowerPoint

What We Offer
We offer a competitive salary of $80,000 - $100,000 per annum, depending on experience, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply.

  • Mumbai, Maharashtra, India KlinEra Global Services Full time

    About KlinEra Global ServicesKlinEra Global Services is a renowned provider of innovative clinical trial and research services. Established in 2005, our company has been delivering efficient and ethical clinical trials that accelerate the delivery of novel therapeutic treatments.With extensive experience in various therapeutic areas, our team ensures...


  • Mumbai, Maharashtra, India KlinEra Global Services Full time

    About KlinEra Global Services: Established in 2005, KlinEra Global Services provides innovative, customized clinical trial and research services to conduct ethical and efficient clinical trials that will accelerate delivery of novel therapeutic treatments with faster patient access.KlinEra Global Services has extensive experience in a diverse number of...


  • Mumbai, Maharashtra, India KlinEra Global Services Full time

    About KlinEra Global Services: Established in 2005, KlinEra provides innovative, customized clinical trial and research services to conduct ethical and efficient clinical trials that accelerate delivery of novel therapeutic treatments with faster patient access.KlinEra has extensive experience in a diverse number of therapeutic areas for the last two...


  • Mumbai, Maharashtra, India KlinEra Global Services Full time

    About KlinEra Global ServicesWe are a leading provider of innovative clinical trial and research services, established in 2005. Our mission is to accelerate the delivery of novel therapeutic treatments by conducting efficient and ethical clinical trials.KlinEra has extensive experience in a diverse range of therapeutic areas, ensuring compliance and...


  • Mumbai, Maharashtra, India KlinEra Global Services Full time

    About KlinEra Global Services: A leading provider of innovative clinical trial and research services, established in 2005. Our mission is to accelerate the delivery of novel therapeutic treatments through efficient and ethical clinical trials.We have extensive experience in a diverse range of therapeutic areas, ensuring compliance and optimal delivery. Our...


  • Navi Mumbai, Maharashtra, India Lifelancer Full time

    About the RoleWe are seeking a Clinical Research Associate to join our team at Lifelancer, a talent hiring platform in Life Sciences, Pharma, and IT.The successful candidate will be responsible for the proper conduct of clinical studies, ensuring compliance with all applicable regulations, protocols, and regulatory requirements.Key responsibilities will...


  • Mumbai, Maharashtra, India PSI CRO Full time

    Job Title: Lead Clinical Research AssociateAt PSI CRO, we are seeking a highly skilled and experienced Lead Clinical Research Associate to join our team.Job Summary:The Lead Clinical Research Associate will be responsible for overseeing the clinical research projects, ensuring timely completion, and maintaining high-quality standards. This role will involve...


  • Navi Mumbai, Maharashtra, India Lifelancer Full time

    About the RoleWe are seeking a highly skilled Clinical Research Scientist to join our team at Lifelancer. As a Clinical Research Scientist, you will be responsible for the proper conduct of clinical studies, ensuring compliance with all applicable regulations and requirements.Key Responsibilities:Comply with all applicable regulations and complete required...


  • Navi Mumbai, Maharashtra, India Lifelancer Full time

    About the RoleWe are seeking a highly skilled Clinical Research Scientist to join our team. As a key member of our clinical development team, you will be responsible for the conduct of clinical studies, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.Key ResponsibilitiesConduct clinical studies in accordance with...


  • Navi Mumbai, Maharashtra, India Lifelancer Full time

    About the RoleWe are seeking a highly skilled Clinical Research Scientist to join our team at Lifelancer. As a Clinical Research Scientist, you will be responsible for the proper conduct of clinical studies, ensuring compliance with all applicable regulations and requirements.Key Responsibilities:Comply with all applicable regulations and complete required...


  • Navi Mumbai, Maharashtra, India Teva Pharmaceuticals Full time

    About the RoleWe are seeking a skilled Clinical Research Associate I to join our team at Teva Pharmaceuticals. In this role, you will be responsible for overseeing the smooth running of BA/BE studies, collecting and compiling data, and ensuring adherence to research regulatory standards and in-house SOPs.Key ResponsibilitiesOversee the smooth running of...


  • Navi Mumbai, Maharashtra, India Lifelancer Full time

    About the RoleAt Lifelancer, we are committed to making good health more affordable and accessible to millions around the world. As a Clinical Research Scientist, you will be part of a team that is dedicated to this mission. Key ResponsibilitiesBefore the study starts, you will need to comply with all applicable regulations, complete required forms, and...


  • Navi Mumbai, Maharashtra, India Lifelancer Full time

    About the RoleJoin Teva Pharmaceutical Industries, a global leader in generic medicines, where we are committed to making good health more affordable and accessible. As a Clinical Research Scientist, you will be part of a diverse and inclusive team working towards a common goal of improving lives.Key ResponsibilitiesResponsible for the proper conduct of...


  • Navi Mumbai, Maharashtra, India Lifelancer Full time

    About this opportunityAt Lifelancer, we're committed to making good health more affordable and accessible. We're a global team of experts working together to help millions around the world enjoy healthier lives.As a Clinical Research Scientist, you will be responsible for conducting clinical trials in accordance with Good Clinical Practice (GCP) and...


  • Mumbai, Maharashtra, India 1054 GlaxoSmithKline Services Unlimited Full time

    Job Title: Senior Director, Clinical LeadWe are seeking a highly experienced Senior Director, Clinical Lead to join our team at GSK. As a key member of our Clinical Development team, you will be responsible for providing clinical and scientific support for potential new, established, and emerging indications for a late-stage asset in the respiratory...


  • Mumbai, Maharashtra, India Lifelancer Full time

    Seeking a talented individual to support clinical trials from start-up to close-out as a Clinical Trial Coordinator. In this role, you will provide administrative and technical support to the project team, ensuring high-quality and cost-efficient clinical studies.Responsibilities:Provide administrative support to the project team.Support audit readiness by...


  • Mumbai, Maharashtra, India 1054 GlaxoSmithKline Services Unlimited Full time

    Job Title: Clinical Lead Senior DirectorWe're seeking a Clinical Lead Senior Director to provide clinical and scientific support for potential new, established, and emerging indications for a late-stage asset in the respiratory portfolio.Key Responsibilities:Lead the end-to-end clinical development strategy for a drug or program.Manage specific clinical...


  • Mumbai, Maharashtra, India KlinEra Global Services Full time

    Job Title: Senior Clinical Project ManagerAt KlinEra Global Services, we are seeking a highly skilled and experienced Senior Clinical Project Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for managing Clinical Operations activities and providing functional supervision for Clinical Operations...


  • Mumbai, Maharashtra, India 1054 GlaxoSmithKline Services Unlimited Full time

    We are seeking a Clinical Development Director to provide clinical and scientific support for potential new, established, and emerging indications for a late-stage asset in the respiratory portfolio. As a Senior Director of Clinical Development, you will work with project teams to plan and assure delivery of clinical research and development activities.Key...


  • Mumbai, Maharashtra, India 1054 GlaxoSmithKline Services Unlimited Full time

    We are seeking a Senior Director, Clinical Lead to provide clinical and scientific support for potential new, established, and emerging indications for a late stage, asset in the respiratory portfolio.Key Responsibilities:Lead the end-to-end clinical development strategy for a drug or program.Manage specific clinical development plans for product(s) and/or...