Clinical Operations Specialist

7 days ago

Bengaluru, Karnataka, India beBeeClinicalAssociate Full time
Job Description

As a Clinical Associate, you will play a crucial role in supporting the management of clinical trials, laboratory operations, and specimen management. Your primary responsibilities will include:

  • Developing and implementing effective Specimen Test Plan (STP) strategies to ensure timely and efficient data collection.
  • Coordinating with cross-functional teams to plan and execute review schedules, allocate time for investigation, and resolve issues promptly.
  • Utilizing strong analytical and troubleshooting skills to identify errors, implement resolution steps, and suggest process improvements.
  • Providing training and guidance to staff on SOPs, validation standards, and work procedures.
  • Supporting the management of metrics and quality assurance initiatives.

Metric Management

  • Collaborate with the quality team to develop and implement metrics that align with business objectives.
  • Assist in investigating or resolving issues of quality as directed by management.

Staff and Financial Management

  • Understand the financial implications of activities on project budgets.

Process Improvement

  • Identify areas for process improvement and suggest changes to enhance efficiency and effectiveness.
  • Support Six Sigma process improvement teams in implementing sustainable changes.

Training / SOPs

  • Review and update training materials to ensure accuracy and relevance.
  • Mentor and support other employees in their understanding and adoption of STPs.

Other Responsibilities

  • Lead or assist with special projects as designated by management.
Required Skills and Qualifications

To succeed in this role, you must possess:

  • A minimum of 2-3 years of experience working in clinical trials, laboratory, or specimen management.
  • Proven ability to plan, prioritize, and manage in a fast-paced environment.
  • Strong drive for process optimization and data integrity.
  • Excellent communication and interpersonal skills.
  • Detail-oriented with the ability to work independently and effectively collaborate with clients.
  • Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO, or related industry.
  • Ability to analyze, solve, and correct issues in real-time.
  • Strong MS/Office skills, particularly Excel and Word.
Education / Qualifications / Certifications and Licenses

Minimum required:

  • University/College Degree (Life Science preferred), or certification in an allied health profession from an accredited institution.
  • 1-2 years of work experience in clinical research industry, laboratory, or specimen management.

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