About Infoclin Consultancy:
Infoclin is a India based east-india focused provider of comprehensive clinical trial management services. IFL is built around passionate and experienced individuals working alongside our clients to accelerate clinical research and delivery of new drugs and medical devices to the markets, while maintaining high standards of quality. We are also committed to improving and expanding the clinical research enterprise, evident through our presentations at industry conferences, publishing in industry trade magazines and journals and through visiting professorship at academic institutions. Here are some basic facts about IFL:
- Clinical operations team is one of the most experienced and respected in India with over 99 years of collective experience.
- Team has conducted more than 100 global and domestic trials at plenty of sites and with innumerable of patients
- Trained over 500 clinical research personnel in India
- Executive team has spoken at an estimated 100 conferences and has been published over 50 times in industry trade journals and magazines
- Management team brings experience from some of the most respected and recognized companies within the clinical trials industry and the world, including: Quintiles, PPD, Excel.
- Our extensive domain knowledge helps us understand the expectations and needs of biopharmaceutical and device companies. Our operations team and our strategic partners ensure the most cost effective and efficient execution of global drug and device development programs.
OUR ENDEAVOUR IS TO IMPROVE CLINICAL RESEARCH CONDUCT BY:
Deploying best-in-class clinical research site solutions that deliver efficient, predictable, auditable and ethical clinical trials Creation of scalable technology platforms to access clinical research sites and patient networks in emerging markets Partnering with networks of hospitals, doctors and patients, Infoclin helps create an ecosystem for pharmaceutical research and better health.
IFL(INFOCLIN CONSULTANCY) DIFFER
- IFL (Infoclin Consultancy) provides the unique combination of local and global support to the client for their projects.
- The key differentiators include: More than 150 man years of experience in managing global and domestic clinical research projects
- Medical expertise to support the global client on a 24/7 basis
- Site centric model to support in the day-to-day activities
- Highly experienced and trained Clinical Research Coordinators (CRC) to support the site team and generate high quality data
- CRC support for audio-visual consenting procedures
- Regulatory support for global and domestic clients
- Coordinate with EC for timely submission, follow up and approval
- Project and site specific recruitment activities for faster enrolment
- Timely submission of safety reports to the EC and the regulatory
- Experienced in regularity inspections
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About Infoclin Consultancy Kolkata Job Vacancy:
Infoclin Consultancy, the leading Research Management Initiative Organization is hiring Senior Executive Regulatory Affairs in Clinical Research.
Job location : Kolkata
Job Description includes
Updating self with New Drug CT rule_2019
Reviewing of SOP of clinical trial sites
Quality control tasks on submission components
Proficiency with ICH-GCP guidelines
Under supervision, adherence to project milestones and timelines
Contributing to departmental initiatives
Working with team leader to establish individual goals to meet project timelines.
Providing timely communication on status and /or issues pertaining to Clinical research
Knowledge of submission dossier to CDSCO
Paying attention to details for accomplishing publishing tasks
Having industry knowledge; understanding of industry, FDA requirements
With guidance, creating and maintaining project documentation including: meeting agendas, meeting
Minutes of meeting, issues and status reports internally and externally.
Performing relevant duties for projects as assigned.
SAE reporting
Qualification: M.Pharm, M.Sc, PharmD
Experience required: 0 – 1 year ( only relevant experience will be counted)
Salary: No bar for right candidate
The job incumbent must be flexible to travel if needed.
Notice period: Immediate to 15 days Maximum
Interested candidates kindly post across updated CV at hr@infoclinconsultancy.com
