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Clinical Trial Operations Lead

1 month ago

Étreux, Hauts-de-France, United States Brigham & Women's Hospital(BWH) Full time
Job Summary:

The Clinical Trial Protocol Lead is a key member of our team, responsible for ensuring the smooth operation of clinical trials. This individual will work independently and contribute to implementing process improvements, providing guidance and mentorship to staff, and interacting with senior-level study management personnel.

Key Responsibilities:

1. Develop and maintain study-specific SOPs and working instructions in accordance with TIMI operations guidelines, sponsor protocol, and FDA requirements.

2. Identify and implement process improvement opportunities to enhance trial efficiency and quality.

3. Prepare and maintain study aids and training materials for junior staff members.

4. Collaborate with the department/trial manager to address issues identified through quality monitoring activities and audits.

5. Prepare official trial correspondence, develop and maintain databases, and generate reports as needed.

6. Maintain knowledge of regulations, clinical research conduct, laws, guidelines, and standards related to clinical trials.

7. Perform other tasks and responsibilities as directed.

Requirements:

• Bachelor's degree required

• 2-3 years of industry experience in clinical trials and/or relevant experience

• Data management experience preferred

Skills and Abilities:

• High-level proficiency in MS Office products (Word and Excel) and familiarity with databases

• Ability to work independently and display initiative

• Detail-oriented and customer service-oriented

• Strong organizational skills and ability to manage multiple tasks concurrently

• Ability to communicate effectively in a matrix environment and demonstrate professionalism

Working Conditions:

Busy office environment with frequent deadlines.