Senior Research ociate istant Scientist BioClinicalStudies
2 months ago
JobDescription:
Role: SeniorResearch Associate/ Assistant Scientist Bio ClinicalStudies
Reporting to: Associate DirectorBioClinical Studies
Location:Hyderabad
Experience: At least 7 years ofindustrial experience in the field of BioClinical Studies with M.Pharma or 4 years of industrial experience with Ph.D.
Qualification: M. Pharma/ M.S or Ph.D.(Pharmacology/Medicine) or equivalent from a reputedUniversity.
Purpose of the Role: Supporting andguiding projects through proof of concept to clinical developmentfor LBOE Global projects
KeyDeliverables:
- SupportSynopsis development planning and management of early to late phaseclinical development studies to achieve Clinical studies for proofof concept /registration of product in India globalmarkets.
- Support Planning and management ofBA/BE studies in healthy volunteers to achieve Proof of concept/registration of products in India globalmarkets
- Manage study activities at CROs andGlobal Dept.s to achieve Management compliance as per requirementsof Ferring/GxP/ Regulatory
- Coordinate fornonclinical and clinical study supplies Investigational medicinalproduct (IMP NIMP Biological samples etc.) to achieve IMPsupply
- Support QA compliance for nonclinicalGLP studies to achieve Quality compliance
- Perform and Support Review of dossier for submission to RegulatoryAuthority to achieve Regulatory compliance
- Perform and Support review of Bioanalytical method developmentvalidation reports to achieve High Qualitydata
- Perform and Support review of scientificdata (PK / PD and statistical data/ results) to achieve HighQuality data
- Perform and Support evaluation ofclinical and nonclinical study Vendors facilitating QA audit andselection of vendors to achieve Qualifiedvendors.
PreferredCompetencies for success in the role:
- Hands on experience in BABEstudies.
- Experience in drug productdevelopment in early to late phase clinicaldevelopment
- Hands on experience in PKPDtranslation
- Exposure to nonclinical studieswill be an added advantage.
- Trained in GoodClinical Practices (GCP)
- 5 years of experiencein Clinical Trials and BA/BE studiesmanagement
- Experience in clinical trial supplymanagement (IMP biological samples etc.)
- Thorough knowledge of regulatory ethical requirements Qualitystandards PV etc.
- Experience in medicalwriting biostatistics Data Management CTMS vendor managementetc.
- Experience of trial/study monitoring andhandling GxP audit and regulatory inspectionsetc.
Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma andIT. The platform connects talent with opportunities in pharmabiotech health sciences healthtech data science and ITdomains.
Please use the below Lifelancer linkfor job application and quickerresponse.
/jobs/view/f640faba216ff620d8bff218
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