Director at Vertex Corporate Services India Pvt Ltd
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Manager - Clinical Research/Clinical Operations - Pharma (10-16 yrs)
Position : Clinical Research Manager-Clinical Operations (Leading MNC Pharma Company)
- Lead the team consisting of Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs) and Project Managers (PMs)
- Overseeing global & local clinical projects, ensuring their execution in a timely and effective manner within budget and complying with regulatory requirements
- Lead the quality clinical trial projects, track tasks performed by CRAs, CTAs & PMs for their timely and effective execution for local clinical trials
- Reviewing of key regulatory documents ensuring it complies with requirements
- Co-monitoring the visits with the clinical research associate for the quality execution of the clinical trials, quality audits and inspection issues
- Responsible for the hiring, development and line managementof the CRAs, CTAs and PMs.
- In collaboration with the Clinical Operation Head coordinate country level protocol feasibility, identification of potential sites, coordinating site assessments and elect appropriate sites and site initiations to allocate local clinical trials
- Responsible for effective site recruitement, providing the necessary criteria for the successful staffing
- Networking with institutions and academicians in identifying good centres for clinical trials.
- Provide trial related communication and insight to key internal and external stakeholders, maintain ongoing communication with the Ethics Committees
- Master's degree in Medicine, Science, Pharmacy or other relevant degree from a reputed institution
- 10+ years of experience working in clinical research, out of which 3-4 years in trial management and a minimum of 6 yearsof experience in conducting clinical trials as CRA
- Well trained in ICH-GCP guidelines
- Excellent communication skill both oral and written
- Strong at people management & stakeholder management
- strong track record in thorough planning, execution and follow-up is required, with a creative and innovative attitude that will enable you to drive initiatives with operational excellence in mind
This position is for a Client of Vertex Corporate Services which is a Leading MNC Pharma Company
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