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56 Medpace Clinical Research India Jobs
Senior Study Start up Submissions Coordinator
Medpace Clinical Research India
posted 11hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- To perform close follow up of Clinical Trials submitted to Drugs Controller General of India (DCGI), Face to face visits expected Facilitate meetings with DCGI, support consultation processes when needed Efficiently manage and successfully execute all aspects of local and Regional APAC start-up; Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs) and regulatory agencies (minimum CDSCO and DCGI) Perform quality checks on submission documents and site essential documents; Prepare and approve informed consent forms; Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and Present during bid defenses, general capabilities meetings, and audits
- We are currently seeking a full-time, remote-based Senior Study Start up Submissions Coordinator to join our Clinical Operations team in India, Delhi
- Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners
- At Medpace, our employees embody our values and our approach to serving our clients
- They work hard, understand our high expectations, and rise to the challenge
- In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint
- These are just a few reasons why talented individuals join the Medpace team
- Responsibilities To perform close follow up of Clinical Trials submitted to Drugs Controller General of India (DCGI), Face to face visits expected Facilitate meetings with DCGI, support consultation processes when needed Efficiently manage and successfully execute all aspects of local and Regional APAC start-up; Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs) and regulatory agencies (minimum CDSCO and DCGI) Perform quality checks on submission documents and site essential documents; Prepare and approve informed consent forms; Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and Present during bid defenses, general capabilities meetings, and audits
- Qualifications Bachelor s degree and more than 8 years of regulatory submissions experience in clinical research, preferably with a CRO
- Experience may include CRA or project management experience; Strong Local experience mandatory for RSC level, Local and Regional APAC experience mandatory for RSM level Strong oral and written communication skills
- Hands-on experience preparing, reviewing, and submitting regulatory documentation to EC and RA; including formulating responses to queries Medpace Overview Why MedpacePeople
Employment Type: Full Time, Permanent
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What Medpace Clinical Research India employees are saying about work life
based on 8 employees
Flexible timing
Monday to Friday
No travel
Medpace Clinical Research India Benefits
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