Clinical Trial Assistant Project Manager

Mass General Brigham • Somerville, MA

7d • Hybrid

About The Position

Fully knowledgeable of the department/trial(s) protocol requirements, works with a high degree of independence, and contributes to implementing process improvements. By virtue of their experience, expected to provide guidance and mentorship to staff regarding department/trial operations.

Requirements

• Bachelor's Degree Related Field of Study required
• Clinical Trial experience 2-3 years required
• Demonstrated high-level proficiency in MS Office products (Word and Excel) and familiarity with databases.
• Excellent interpersonal, communication, and problem-solving skills, along with attention to detail and follow-through.
• Able to work objectively, exercise discretion, and maintain strict confidentiality.
• Time management skills and the ability to function effectively within a changing environment.
• Solid written and verbal communication skills.

Nice To Haves

• Data Management experience 2-3 years preferred

Responsibilities

• Manage multiple clinical trial sites for the duration of the trial.
• Collect and review essential regulatory documents for completeness before submitting them to Regulatory for final review and/or approval.
• Advise research sites on protocol conduct and interpretation, and ensure the resolution of any issues.
• Evaluate the quality and timeliness of data entry, issue, track, and resolve queries, and implement corrective action plans as needed.
• Maintain a clinical trial database that includes the latest protocol versions and updated contact information.
• Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
• Prepare official trial correspondence (i.e., numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases.
• Assist in the training and development of other junior staff members in key processes and procedures.
• Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level