PK Analyst
- Golden Opportunities
- 4 - 10 Years
- Chennai
- 5 years ago
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Job Description
Pharmacokinetics- PKO/Mumbai/Pune/Delhi/BangalorePreferred Educational Qualification for the role: Bachelors / master degree/Ph.D. in Statistics Mathematics Life Sciences or related fields
Candidate Specification: In-depth knowledge of clinical development clinical pharmacology and PK/PD is required.
Proficient in using WinNonlin or other relevant pharmacokinetic software for PK/PD analysis and SAS.
Good communication and interpersonal skills. Skilled in scientific writing and data interpretation
Salary Best in Industry
Job Responsibilities:
- Monitor and support conduct of PK data analysis using software such as WinNonlin and/or NONMEM
- Play an active role on cross-functional project teams as a PK office representative
- Review and provide contributions to the Statistical Analysis Plans and or write separate PK Analysis Plans
- Contribute to the clinical pharmacology sections of relevant documents such as clinical study protocols clinical study reports investigators brochures briefing documents and regulatory submissions
- Work closely with regulatory affairs personnel if required to provide PK data in support of regulatory communications and presentations as needed
- People/project management along with ensuring day to day operations
- Ensure the optimal quality of deliverables by assigning layers of peer/internal QC before sharing the output with sponsor/client
- Ensure allocation of qualified and well-trained resources to the study
- Ensure required trainings are completed on time for an individual before starting with production work
- Coordination with sponsor/client to ensure the receipt of pre-requisites on time
- Providing applicable and required study metrics to Customer Lead / Project Manager / Delivery Manager
- Provide support and mentoring to staff on various PK procedures processes and concepts to ensure the highest standards of quality productivity planning client service and Compliance are achieved
- Participating in all strategic / operations meeting
- Liaison with client to understand the expectations and the corresponding actions
- Liaison with client to discuss the Company processes work status challenges etc.
- Conduct / facilitate knowledge sharing sessions training and other learning initiatives
Employement Category:
Employement Type: Full timeIndustry: Bio Technology & Life SciencesFunctional Area: PharmaceuticalRole Category: Clinical Research AssociateRole/Responsibilies: PK AnalystContact Details:
Company: Golden OpportunitiesLocation(s): Chennai+ View Contact
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