Senior Clinical Research Associate
3 weeks ago
Job Title: Senior Clinical Research Associate
Job Summary:
Life Sciences company is seeking a Senior Clinical Research Associate to support the planning and management of early to late phase clinical development studies. The ideal candidate will have experience in drug product development, PKPD translation, and nonclinical studies.
Key Responsibilities:
- Support synopsis development planning and management of clinical development studies.
- Plan and manage BA/BE studies in healthy volunteers.
- Manage study activities at CROs and Global Departments.
- Coordinate for nonclinical and clinical study supplies.
- Support QA compliance for nonclinical GLP studies.
- Perform and support review of dossier for submission to Regulatory Authority.
- Perform and support review of bioanalytical method development and validation reports.
- Perform and support review of scientific data.
- Perform and support evaluation of clinical and nonclinical study 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.
- Thorough knowledge of regulatory ethical requirements.
- Experience in medical writing, biostatistics, data management, and vendor management.
About the Company:
Lifelancer is a talent hiring platform in Life Sciences, Pharma, and IT, connecting talent with opportunities in various domains.
How to Apply:
Please use the below Lifelancer link for job application and quicker response.
/jobs/view/f640faba216ff620d8bff218
Work Location:
Hyderabad
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