Study Start Up Submissions Manager

🕒 January 11

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Medpace

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1992

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Medpace is a full-service contract research organization (CRO) that accelerates the development of safe and effective medical therapeutics. The company offers a comprehensive range of services to biopharmaceutical companies, including clinical trial management, regulatory affairs, and integrated laboratory services. With expertise across various therapeutic areas, Medpace facilitates collaboration among medical professionals to optimize the clinical development process and enhance trial efficiency.

📋 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; • 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