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Premier Research Hiring Clinical Trial Associate

Published on

Premier Research

1 - 4 Years

Bangalore, India

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

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Premier Research stands at the forefront of life sciences, helping biotech, medtech, and specialty pharma companies turn groundbreaking ideas into transformative medicines, devices, and diagnostics. Dedicated to improving lives, Premier Research is committed to fostering an environment where employees are valued as the most critical asset in delivering success.

As a Clinical Trial Associate II, you’ll play a pivotal role in ensuring clinical trial operations run smoothly, maintaining quality and compliance while supporting the medical innovations patients need.

Key Responsibilities of a Clinical Trial Associate II

  1. Document Management:
    • Maintain the Trial Master File (TMF)/electronic Trial Master File (eTMF) as per company and regulatory standards.
    • Review and ensure site documents meet all applicable guidelines, including ALCOAC standards.
    • Perform quality reviews, completeness checks, and resolve queries related to eTMF.
    • Support the clinical team with document translations and essential document reviews during study phases.
  2. Data Entry, Tracking, and System Support:
    • Assist in setting up Clinical Trial Management Systems (CTMS) and maintain project tracking systems.
    • Track and document distribution of essential materials like Investigator’s Brochure and safety reports.
    • Manage access to systems for site staff and clinical team, conducting routine reviews to ensure compliance.
    • Ensure project-specific training matrices are maintained, and compliance reports are updated.
  3. Support and Collaboration:
    • Attend and assist with internal clinical meetings, including preparation and follow-up on decisions and actions.
    • Collaborate with third-party vendors for issue resolution.
    • Assist in the development of study materials and coordinate logistics, such as creating and distributing Investigator Site Files (ISF).
    • Mentor and train junior Clinical Trial Associates.
  4. Additional Contributions:
    • Identify and escalate project-related issues, proposing solutions in collaboration with the Project Team and Line Manager.
    • Participate in departmental initiatives and contribute to overall team success.

Qualifications and Skills Required

To excel in this role, you should meet the following qualifications and possess the requisite skills:

Qualifications:

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
  • Prior experience in clinical trial management or a similar role.

Key Skills:

  • Strong knowledge of clinical trial processes, regulatory guidelines, and document management systems like eTMF.
  • Proficiency in project tracking systems and databases, including CTMS, EDC, and IWRS.
  • Excellent organizational and problem-solving skills.
  • Effective communication and interpersonal abilities.
  • Ability to work collaboratively in a team and independently handle tasks with minimal supervision.

Application Link