Senior Research Scientist BioClinical Studies Professional

3 weeks ago


Hyderabad, Telangana, India Lifelancer Full time

Job Title: Senior Research Scientist BioClinical Studies Professional

Job Summary:

Life Sciences talent hiring platform Lifelancer seeks a Senior Research Scientist BioClinical Studies Professional to support projects through proof of concept to clinical development for LBOE Global projects.

Key Responsibilities:

  1. Develop and manage early to late phase clinical development studies to achieve clinical studies for proof of concept/registration of products in India global markets.
  2. Plan and manage BA/BE studies in healthy volunteers to achieve proof of concept/registration of products in India global markets.
  3. Manage study activities at CROs and Global Dept.s to achieve management compliance as per requirements of Ferring/GxP/Regulatory.
  4. Coordinate for nonclinical and clinical study supplies Investigational medicinal product (IMP NIMP Biological samples etc.) to achieve IMP supply.
  5. Support QA compliance for nonclinical GLP studies to achieve quality compliance.
  6. Review of dossier for submission to Regulatory Authority to achieve regulatory compliance.
  7. Review of Bioanalytical method development validation reports to achieve high quality data.
  8. Review of scientific data (PK/PD and statistical data/results) to achieve high quality data.
  9. Evaluation of clinical and nonclinical study Vendors facilitating QA audit and selection of vendors to achieve qualified vendors.

Requirements:

  • Hands on experience in BA/BE studies.
  • Experience in drug product development in early to late phase clinical development.
  • Hands on experience in PKPD translation.
  • Exposure to nonclinical studies will be an added advantage.
  • Trained in Good Clinical Practices (GCP).
  • 5 years of experience in Clinical Trials and BA/BE studies management.
  • Experience in clinical trial supply management (IMP biological samples etc.).
  • Thorough knowledge of regulatory ethical requirements quality standards PV etc.
  • Experience in medical writing biostatistics Data Management CTMS vendor management etc.
  • Experience of trial/study monitoring and handling GxP audit and regulatory inspections etc.

Apply for this role through the Lifelancer job link /jobs/view/f640faba216ff620d8bff218 to get quicker responses.



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