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0.0 - 4.0 years
3 - 5 Lacs
Ahmedabad
Work from Office
Role & responsibilities : Work as Pharmacokinetic and Scientific Affairs Personnel. 1. Provide feasibility inputs like study design, sample size estimation, sampling time points, wash out period, etc. 2. Review, evaluation and interpretation of PK/PD data from BA/BE studies-clinical trials and suggesting appropriate inputs in protocol and clinical study report 3. Review statistical report as per requirement. 4 Prepare and review statistical/pharmacokinetic analysis plan as per requirement 5. Archive and retrieval of data 6. Maintain and update feasibility database as per requirements 7. Maintain and assist regulatory query handling and tracking. 8. Provide impact assessment of PK related protocol deviations/Con-med assessment Preferred candidate profile: M. Pharma with min.1-2 years of relevant experience as PK Scientist in Clinical research (BA/BE studies). Job Location: Ahmedabad
Posted 2 weeks ago
2 - 7 years
5 - 7 Lacs
Ahmedabad
Remote
We are looking for a candidate for Costing & Proposal- North America in Cliantha Research Limited. Job timing: 05:00 PM to 02:00 AM Job location : Remote Job Description: Preparation and completion of all RFPs upon request and assignment. Analyze quotes and cost sheets/templates and optimize where applicable. Preparation and completion of Work orders / Change Order requests. Use business analytical skills to seek efficiencies in cost containment. Work with and communicate across multiple levels of business and stakeholder organizations to determine how to improve existing business processes. Performs all work in accordance with established departmental processes, regulatory requirements, while working in compliance with safety standards Experience Required: 3 years of CRO / pharmaceutical or equivalent business experience preferred Excellent business writing, communication, editing and proofreading skills Ability to meet stated deadlines Ability to work independently and collaboratively as required Strong analytical and problem solving skills, with demonstrated ability to plan, multi-task and prioritize, with a strong process background Proficient in spreadsheet and database applications Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively Excellent interpersonal skills and ability to relate well to internal and external customers Strong written and verbal communication skills Ability to make effective decisions in a timely manner Strong technical proficiency and computer skills in all aspects of MS Windows and MS Office software packages Interested Candidates can share the resume on recruitment1@cliantha.com
Posted 1 month ago
- 2 years
6 - 9 Lacs
Mangaluru
Work from Office
Roles and Responsibilities Responsible for screening volunteers for clinical study and to decide the eligibility of a subject based on detailed history, physical examination, radiological and electrocardiograph and laboratory parameters. Monitoring, Reporting and Management of Adverse Events/ Serious Adverse Events occurring during clinical study Determination of Volunteer eligibility for Clinical Study as per Inclusion/exclusion criteria of protocol. Maintenance of Emergency Drugs List and ICU set-up. Maintain records of screening procedures as per GCP and other applicable regulatory requirements. Co-ordinate with respective CI/PI/Head in all study related activities. Perform any other activities as and when assigned by the management Desired Candidate Profile Qualification: MBBS with Medical Council registration Job Location: Mangalore - Karnataka (Office based)
Posted 1 month ago
0 - 4 years
1 - 6 Lacs
Ahmedabad
Work from Office
MD/MV group does assay method development and validation for various drug and their metabolites in biological fluids like plasma serum or urine by using LC/MS/MS. During method validation precision, accuracy, stability of drug/metabolite in biological fluid as well as after extraction is evaluated. The validated methods are then followed for the analysis of subject samples analysis for doing bioequivalence study. Candidates must experience in MD-MV onto LC/MS/MS for drugs and their metabolites in various biological fluids. Well versed in operating and trouble shooting LC/MS/MS instruments. Well versed in literature search, basic computer knowledge and MS-office. Aware of recent trends in regulated bioanalysis and regulatory guidelines Perform the extraction of samples using wet chemistry. Centrifuges, evaporators, freeze specimens as required. Performs aliquots of samples for wet chemistry. Performs wet chemistry according to study protocol guidelines and/or SOPs. Completes QC sheets and makes log book entries as required by protocol and/or SOP. Operate HPLC, LC/MS/MS and ICP-OES; troubleshoots problems and performs minor repairs
Posted 3 months ago
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