Regulatory Submissions (Study Start-up) Manager

Medpace; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated Study Start Up Submissions Manager to enhance their Clinical Operations team in Singapore. In this full-time role, you will oversee the global start-up process, ensuring all submissions are accurate and compliant. Your expertise in clinical research and project management will be crucial as you navigate challenges and present solutions during key meetings and audits. Join a forward-thinking organization where your contributions will directly impact clinical trials and patient care. If you are passionate about clinical research and thrive in a dynamic environment, this opportunity is perfect for you.

Qualifications

• Over 5 years of experience in clinical research, preferably with a CRO.
• Strong oral and written communication skills are essential.

Responsibilities

• Manage and execute all aspects of global start-up efficiently.
• Perform quality checks on submission documents and site essential documents.

Skills

Clinical Research

Project Management

Communication Skills

Job description

Job Summary

We are currently seeking a full-time Study Start Up Submissions Manager to join our Clinical Operations team in Singapore.

Responsibilities

1. Efficiently manage and successfully execute all aspects of global start-up;
2. Perform quality checks on submission documents and site essential documents;
3. Prepare and approve informed consent forms;
4. Review pertinent regulations to develop proactive solutions to start-up issues and challenges;
5. Present during bid defenses, general capabilities meetings, and audits.

Qualifications

1. More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
2. Regional experience will be highly advantageous;
3. Strong oral and written communication skills.

Travel: Minimal