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27/09 Ashish
HRM at Konnect HR

Views:6653 Applications:88 Rec. Actions:Recruiter Actions:2

Assistant Project Leader - Healthcare/Pharma (3-7 yrs)

Mumbai Job Code: 379572

Skills :

Education : M.Pharm or equivalent with solid clinical trial monitoring experience (6-8 years) for dermal formulations, demonstrating successful performance of Clinical Research Associate position

- Experience as a CRA including all steps of the clinical study; i.e. site initiation, site monitoring and site closure

- Exposure to US market filings for ANDA/NDA of Dermatology products is preferred

- Should have previously worked with multiple CROs, both in India and USA

- Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines

- Good command of written and spoken English language

- Good organizational skills, analytical and social skills

- Ability to maintain effective, professional communication

- Ability to prioritize and manage multiple tasks

- Ability to manage and supervise study team members

- Ability to handle multiple tasks with conflicting deadlines and be able to prioritize

Responsibilities :

- Inviting proposal for clinical trials

- Selection of CROs for clinical trials

- Review of Clinical trial protocols

- Preparing and conducting pre-study activities, site selection, initiation visits, routine monitoring and close-out visits

- Performing feasibilities

- Preparing applications to ethics committees and supporting the regulatory department with the application to the regulatory authorities

- Planning and participating at Investigator's meeting(s)

- Responsible for the site(s) and on-site management during the study process

- Ordering and coordinating study supplies

- Preparing study documentation and assisting the Clinical Quality Assurance Manager/regulatory authorities during audits/inspections in-house or on site

- Negotiating contracts with the clinics, local/central laboratory(ies)/pharmacy etc.

- Responsibility for the final archiving of all study documentation in-house

- Monitoring and Oversight - communicating with study teams and sponsors

- Regulatory Documentation Management

- Administration - Providing status Reports to line manager

- Planning budget activities for the trials

- Managing timelines and deliverables for the trials

- Bridget between trial site and CMC team for the supply of trial medications

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Women-friendly workplace:

Maternity and Paternity Benefits

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