Clinical Trial Manager II

1 day ago

Mumbai, Maharashtra, India Syneos Health Full time ₹ 6,00,000 - ₹ 18,00,000 per year

Job Responsibilities

  • minimum 2 Years of project management experience.
  • Should have global pharma experience.
  • Candidate from Mumbai location preferred.
  • Develop and coordinate Phase 1 clinical research studies, ensuring all aspects of the study are meticulously planned and executed
  • Implement clinical research protocols and ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines
  • Collaborate with principal investigators, research subjects, client teams, and clinic operations teams to facilitate smooth communication and coordination
  • Plan and manage logistics and resource usage for clinical trials, including scheduling, budgeting, and resource allocation
  • Track study progress and ensure alignment with project milestones, client deliverables, and budget, providing regular updates to stakeholders
  • Prepare and present study reports and updates to stakeholders, including detailed analysis of study data and progress
  • Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes or updates
  • Provide guidance and support to lower-level professionals and team members, fostering a collaborative and supportive work environment
  • Identify and resolve any issues or challenges that arise during the course of the study, ensuring timely and effective solutions
  • Maintain accurate and comprehensive documentation of all study-related activities, ensuring transparency and accountability

Qualifications:

  • Bachelor's degree in a related field (e.g., life sciences, clinical research)
  • Minimum of 3 years of experience in clinical trial management or a related field
  • In-depth knowledge of clinical research processes and regulations
  • Strong project management and organizational skills
  • Excellent communication and interpersonal skills
  • Ability to work independently and as part of a team
  • Proficiency in using clinical trial management software and tools

Certifications:

  • Certified Clinical Research Professional (CCRP) or equivalent certification preferred

Necessary Skills:

  • Strong analytical and problem-solving skills
  • Attention to detail and accuracy
  • Ability to manage multiple projects and priorities simultaneously
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
  • Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

  • Clinical Trial Process Manager

    1 week ago

    Mumbai, Maharashtra, India beBeeClinicalTrialProcessLeader Full time ₹ 35,00,000 - ₹ 55,00,000

    Clinical Trial Process LeaderAs a seasoned expert in clinical operations, you will play a pivotal role in overseeing the overall clinical trial process. Your extensive knowledge of drug development and registration processes in India enables you to navigate complex regulatory landscapes.Key Responsibilities:Lead cross-functional study teams ensuring seamless...

  • Clinical Trial Site Manager

    1 week ago

    Mumbai, Maharashtra, India beBeeNegotiation Full time US$ 1,20,000 - US$ 1,70,000

    Job OpportunityWe are seeking a highly skilled Site Contract Manager. This role will be responsible for managing contracts and agreements with clinical trial sites, ensuring compliance with regulatory requirements.Key ResponsibilitiesPrepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company-sponsored and/or...

  • Manager Clinical Quality Compliance andTraining

    2 weeks ago

    Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Position Title: Sr. Manager/ Manager Clinical Quality Compliance and TrainingYOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective.This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical...

  • Medical Professional for Clinical Trials

    2 weeks ago

    Mumbai, Maharashtra, India beBeeDermatologist Full time ₹ 30,00,000 - ₹ 60,00,000

    Job Title: Clinical Trials Dermatologist The role of a Clinical Trials Dermatologist involves conducting clinical trials and providing medical care to patients with skin conditions. This position requires expertise in dermatological evaluation, diagnosis, and treatment. Key Responsibilities:Conducting clinical trials as Investigator or Co-investigator with...

  • Clinical Quality Compliance

    7 days ago

    Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Our organization is seeking a highly skilled professional to fill the role of Regulatory Affairs Specialist - Clinical Trials. This position involves developing strategic plans for biosimilar clinical development, designing and implementing protocols for clinical trials, reviewing and finalizing applications, and preparing regulatory submissions.The ideal...

  • Clinical Trials Specialist

    6 days ago

    Mumbai, Maharashtra, India beBeeClinicalResearch Full time ₹ 40,00,000 - ₹ 50,00,000

    Clinical Research Associate RoleWe are seeking a highly motivated and experienced Clinical Research Associate to join our team. In this role, you will be responsible for monitoring clinical trials, ensuring compliance with regulatory requirements, and facilitating site-level documentation.

  • Manager-Biologics Regulatory Affairs(Clinical Trials)

    2 weeks ago

    Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time

    About USV Private Limited: USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries. Function: Biologics Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US. Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))...

  • Manager-Biologics Regulatory Affairs(Clinical Trials)

    2 weeks ago

    Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time

    About USV Private Limited:USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.Function: BiologicsPosition: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday...

  • Manager-Biologics Regulatory Affairs(Clinical Trials)

    3 weeks ago

    Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time

    About USV Private Limited:USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.Function: BiologicsPosition: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday...