Study Start up Submissions Manager

We are currently seeking a full-time, office-based Study Start up Submissions Manager to join our Clinical Operations team in India.

• Efficiently manage and successfully execute all aspects of local and global start-up;
• Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs) and regulatory agencies (minimum DCG);
• 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.

• 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;
• Local and Regional experience will be highly advantageous; and
• Strong oral and written communication skills.