05/02 Shashank
Director at Vertex Corporate Services India Pvt Ltd

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Manager - Clinical Research/Clinical Operations - Pharma (10-16 yrs)

Bangalore Job Code: 17403

Position : Clinical Research Manager-Clinical Operations (Leading MNC Pharma Company)

Role :

- 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

Requirements:

- 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

Location: Bangalore

This position is for a Client of Vertex Corporate Services which is a Leading MNC Pharma Company

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