Study Start Up Submissions Manager
Medpace
full-time
Posted on:
Location Type: Remote
Location: India
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About the role
- 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;
- Present during bid defenses, general capabilities meetings, and audits.
Requirements
- 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.
Benefits
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsclinical researchpreparing regulatory documentationreviewing regulatory documentationsubmitting regulatory documentationquality checksinformed consent formsproject managementCRA experiencelocal and regional APAC experience
Soft skills
strong oral communicationstrong written communicationinterpersonal skillsorganizational skillsproblem-solving skills