Senior Research Associate/Instant Scientist BioClinical Studies
3 days ago
**Job Title:** Senior Research Associate/Instant Scientist BioClinical Studies
**Role:** Support projects from proof of concept to clinical development for LBOE Global projects as a Senior Research Associate/Instant Scientist BioClinical Studies.
**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.
- Plan and manage 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 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.
- Review and support dossier submission to Regulatory Authority to achieve regulatory compliance.
- Review and support bioanalytical method development validation reports to achieve high-quality data.
- Review and support scientific data (PK/PD and statistical data/results) to achieve high-quality data.
- Evaluate clinical and nonclinical study vendors, facilitating QA audit and selection of vendors to achieve qualified vendors.
**Preferred Competencies:**
- 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, and PV.
- Experience in medical writing, biostatistics, Data Management, CTMS, vendor management, etc.
- Experience of trial/study monitoring and handling GxP audit and regulatory inspections, etc.
Lifelancer is a talent hiring platform in Life Sciences, Pharma, and IT. We connect 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: /jobs/view/f640faba216ff620d8bff218
**Work Arrangement:**
No remote work.
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