Senior Research Associate/Assistant Scientist BioClinical Studies

4 weeks ago


Hyderabad, Telangana, India Lifelancer Full time

Job Title: Senior Research Associate/Assistant Scientist BioClinical Studies

Job Summary:

We are seeking a highly skilled Senior Research Associate/Assistant Scientist to join our BioClinical Studies team. The successful candidate will be responsible for supporting and guiding projects through proof of concept to clinical development for LBOE Global projects.

Key Responsibilities:

  • Support synopsis development planning and management of early to late phase clinical development studies to achieve clinical studies for proof of concept/registration of product in India global markets.
  • Support planning and management of BA/BE studies in healthy volunteers to achieve proof of concept/registration of products in India global markets.
  • Manage study activities at CROs and Global Departments to achieve management compliance as per requirements of Ferring/GxP/Regulatory.
  • Coordinate for nonclinical and clinical study supplies Investigational medicinal product (IMP/NIMP/Biological samples etc.) to achieve IMP supply.
  • Support QA compliance for nonclinical GLP studies to achieve quality compliance.
  • Perform and support review of dossier for submission to Regulatory Authority to achieve regulatory compliance.
  • Perform and support review of Bioanalytical method development/validation reports to achieve high-quality data.
  • Perform and support review of scientific data (PK/PD and statistical data/results) to achieve high-quality data.
  • Perform and support 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 PK/PD 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.

About Lifelancer:

Lifelancer is a talent hiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

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