Clinical Trials Operations Lead

2 weeks ago


Bengaluru, Karnataka, India Advarra Full time

Job Overview

We are seeking a seasoned Clinical Trials Operations Lead to join our team at Advarra. In this role, you will be responsible for driving service development and expansion, providing updates to leadership, and acting as the primary liaison and expert for assigned services across the company.

Key Responsibilities

  • Work closely with the Business Operations Services team to drive service development and expansion.
  • Provide Quality Assurance oversight and collaborate on required changes prior to delivering end product to the customer.
  • Act as a subject matter expert within Advarra to ensure guidelines and builds are in accordance with the latest regulations and industry certification provider.
  • Communicate with customers, including Clinical Trial Office administration, investigators, and study teams, upon completion of services requiring communication.
  • Act as a liaison and escalation point for requested changes or questions from customers.
  • Review, understand, and apply information in clinical research protocols, Informed Consent Forms, Clinical Trial Agreements, and other relevant study-related documents when managing or conducting quality assurance.
  • Define processes for internal and external workflows to ensure quality and efficiency, and excellent customer communication.
  • Train or oversee the training of new United States based Business Operations Services team members performing coverage analysis and budget negotiation services ensuring quality and consistency of customer deliverables.
  • Ability to be flexible to collaborate internationally as required.

Requirements

  • High School diploma required.
  • 5+ years of directly related experience in a clinical trials environment, and certification with the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) as a certified clinical research professional within three years of employment.
  • Knowledge of FDA and Medicare regulations related to clinical trials is required.
  • Medical coverage determination experience is required.


  • Bengaluru, Karnataka, India BAN Fortrea Clinical Development Pvt Ltd Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Clinical Trials Coordinator to join our team at BAN Fortrea Clinical Development Pvt Ltd. The successful candidate will be responsible for coordinating clinical trials activities, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.Key...


  • Bengaluru, Karnataka, India BAN Fortrea Clinical Development Pvt Ltd Full time

    Job Summary:We are seeking a highly motivated and detail-oriented Clinical Trials Coordinator to join our team at Fortrea Clinical Development Pvt Ltd. The successful candidate will be responsible for coordinating clinical trials, ensuring compliance with regulatory requirements, and collaborating with internal and external stakeholders.Key...


  • Bengaluru, Karnataka, India Advarra Full time

    Job SummaryWe are seeking a highly skilled Clinical Trials Operations Manager to join our team at Advarra. As a Service Owner, you will be responsible for the success of assigned services, including driving service development and expansion, providing updates to leadership, and acting as the primary liaison and expert for the service across the company.Key...


  • Bengaluru, Karnataka, India Advarra Full time

    Job SummaryAdvarra is seeking a highly skilled Clinical Trials Operations Manager to join our team. As a Service Owner, you will be responsible for the success of assigned services, including driving service development and expansion, providing updates to leadership, and acting as the primary liaison and expert for the service across the company.Key...


  • Bengaluru, Karnataka, India Advarra Full time

    Job SummaryWe are seeking a highly skilled Clinical Trials Operations Manager to join our team at Advarra. In this role, you will be responsible for driving service development and expansion, providing updates to leadership, and acting as the primary liaison and expert for the service across the company.Key ResponsibilitiesWork closely with the Business...


  • Bengaluru, Karnataka, India BAN Fortrea Clinical Development Pvt Ltd Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Clinical Trials Coordinator to join our team at Fortrea Clinical Development Pvt Ltd. As a Clinical Trials Coordinator, you will be responsible for ensuring the smooth execution of clinical trials, from site activation to maintenance.Key ResponsibilitiesDevelop awareness of regulatory...


  • Bengaluru, Karnataka, India Advarra Full time

    Job SummaryWe are seeking a highly skilled Clinical Trials Manager to join our team at Advarra. As a Clinical Trials Manager, you will be responsible for driving service development and expansion, providing updates to leadership, and acting as the primary liaison and expert for the service across the company.Key ResponsibilitiesWork closely with the Business...


  • Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

    As a leading global contract research organization, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.Key Responsibilities:Ownership of country and site budgets.Development, negotiation, and execution of Clinical...


  • Bengaluru, Karnataka, India BAN Fortrea Clinical Development Pvt Ltd Full time

    Job Summary:We are seeking a highly motivated and organized Clinical Trials Coordinator to join our team at Fortrea Clinical Development Pvt Ltd. The successful candidate will be responsible for providing primary contact with investigative sites during study maintenance and start-up activities.Key Responsibilities:Collect and track all necessary documents...


  • Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

    Transforming Clinical Trials with FortreaAt Fortrea, we're revolutionizing the development process by ensuring the swift delivery of life-changing ideas and therapies to patients in need. As a leading global contract research organization, we're seeking a motivated problem-solver and creative thinker to join our exceptional team.Key Responsibilities:Manage...


  • Bengaluru, Karnataka, India PSI Full time

    Job Title: Clinical Trial Startup SpecialistAt PSI, we are seeking a skilled Clinical Trial Startup Specialist to provide operational support to project teams in India. The ideal candidate will ensure that PSI clinical projects start smoothly and on time.Key Responsibilities:Develop site-specific startup timelines and meet site activation targetsProvide...


  • Bengaluru, Karnataka, India George Clinical Full time

    We are expanding our global clinical research capabilities and are seeking a highly skilled medical professional to join our team as a Medical Monitor. As a Medical Monitor, you will be responsible for providing medical and academic input to various aspects of our clinical studies, ensuring project delivery is of high quality, operationally aligned,...


  • Bengaluru, Karnataka, India IQVIA Full time

    Job SummaryWe are seeking a highly skilled Biostatistician to join our team at IQVIA. As a Biostatistician, you will play a key role in the development of statistical methods and analysis plans for clinical trials, as well as contribute to the development of clinical study reports and regulatory responses.Key ResponsibilitiesDevelop statistical methods and...

  • Medical Monitor

    3 weeks ago


    Bengaluru, Karnataka, India George Clinical Full time

    About the RoleThe Medical Monitor is a key member of our global clinical trials team, responsible for providing medical and academic input to various aspects of our studies. This role ensures project delivery is of high quality, operationally aligned, cost-effective, and competitive.Key Accountabilities:Provide medical and academic expertise for new and...


  • Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

    Finding Solutions in Clinical TrialsAt MUM Fortrea Development India Pvt Ltd, we're looking for a motivated problem-solver to join our team as a Clinical Trials Vendor Management Specialist. In this role, you'll be responsible for performing various FSA activities related to purchase orders and receipts within global vendor management.Key...


  • Bengaluru, Karnataka, India Kenvue Full time

    Job Title: Clinical Operations ManagerAt Kenvue, we are committed to delivering the best products to our customers.We are currently recruiting for a Clinical Operations Manager to coordinate the study management operational aspects for Higher complexity clinical studies for regional and/or global projects for Consumer Health products. The successful...


  • Bengaluru, Karnataka, India Kenvue Full time

    Job Title: Clinical Operations ManagerKenvue is a leading global healthcare company that is currently seeking a highly skilled Clinical Operations Manager to join our team. As a Clinical Operations Manager, you will be responsible for coordinating the study management operational aspects for higher complexity clinical studies for regional and/or global...


  • Bengaluru, Karnataka, India Thermo Fisher Scientific Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Sr. Project Support Coordinator to join our team at Thermo Fisher Scientific. As a key member of our clinical trial operations team, you will be responsible for coordinating and overseeing trial activities, ensuring timely completion of tasks, and maintaining high-quality standards.Key...

  • Medical Reviewer

    3 weeks ago


    Bengaluru, Karnataka, India MMS Holdings Inc. Full time

    Medical Reviewer Job DescriptionMMS Holdings Inc. is seeking a highly skilled Medical Reviewer to join our team. As a Medical Reviewer, you will be responsible for providing medical expertise to support the development and implementation of clinical trials and post-marketing safety programs.Key Responsibilities:Provide medical expertise to support the...


  • Bengaluru, Karnataka, India PSI Full time

    Job SummaryPSI is seeking a highly skilled Clinical Trial Startup Specialist to join our team in Bangalore. As a key member of our project team, you will be responsible for ensuring the smooth and timely startup of clinical projects in India.Key ResponsibilitiesDevelop site-specific startup timelines and meet site activation targetsProvide progress updates...