Clinical Research Scientist

4 days ago

Hyderabad, India Techhaul360 Consulting Services Full time

Job Summary:

We are looking for a highly skilled and experienced Clinical Research Scientist with a strong background in Bioequivalence and Bioavailability (BE/BA) studies and clinical operations. The ideal candidate will have over 10 years of experience in the pharmaceutical industry, with a minimum of 7 years in BE/BA studies, and a deep understanding of regulatory requirements for highly regulated markets including USFDA, EMA (EU), and Health Canada.

This role also involves overseeing clinical trials as a Sponsors Representative, managing end-to-end clinical processes, ensuring regulatory compliance, and coordinating with various stakeholders for successful study execution and documentation.

Key Responsibilities:

BE/BA & Regulatory Focus:

  • Design and oversee Bioequivalence and Bioavailability studies across various dosage forms.
  • Ensure strict compliance with regulatory standards (USFDA, Health Canada, WHO).
  • Develop and review study protocols, SOPs, ICFs, and Clinical Study Reports (CSRs).
  • Coordinate with CROs, bioanalytical labs, and internal teams for timely project execution.
  • Interact with regulatory agencies and provide scientific responses to queries/deficiencies.
  • Monitor regulatory trends and update internal SOPs and processes accordingly.

Clinical Study Operations:

  • Serve as Sponsors representative in assigned clinical studies, ensuring ethical and procedural compliance.
  • Oversee dosing of study subjects, subject safety follow-ups, and ensure adherence to ICH-GCP.
  • Review and compile raw clinical data, ensure proper monitoring and quality control (QC).
  • Prepare clinical updates, confinement reports, clinical summary reports, and ensure accuracy of clinical documentation.
  • Review and finalize study documents, then hand over to QA for further processing.
  • Support in EC submissions of protocols and related documentation.
  • Manage study initiation, execution, archival, and retrieval of clinical records.
  • Address and close QA/Sponsor queries and observations.

Required Skills & Competencies:

  • Deep understanding of ICH-GCP and regulatory guidelines (USFDA, CDSCO, Health Canada, WHO).
  • Strong background in pharmacokinetics, clinical study design, and regulatory documentation.
  • Ability to perform both strategic planning and hands-on clinical trial execution.
  • Proficiency in clinical data handling, document management, and compliance tracking.

Preferred Candidate Profile:

  • Strong interpersonal skills and leadership qualities.
  • Exposure to complex generics and/or challenging dosage forms is an advantage.

Educational Qualifications:

  • B.Pharm, M.Pharm, and Ph.D. in Pharmaceutical Sciences, Clinical Research, or a related field

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