Quality Assurance Manager

Mass General Brigham•Somerville, MA

6d•$63,253 - $102,596•Hybrid

About The Position

The Quality Assurance Manager (QAM) supports regulatory compliance and quality assurance for clinical research conducted by the Neurological Clinical Research Institute (NCRI), an Academic Research Organization at Massachusetts General Hospital. Under the supervision of a Senior Quality Assurance Manager and with general direction from a QAM II, the QAM implements quality initiatives in the NCRI Quality Management Plan and helps ensure research is conducted according to the plan, applicable regulations, good clinical practice guidelines, and institutional policies and procedures. The QAM audits clinical research projects coordinated by NCRI, conducts internal reviews of staff adherence to written procedures, and supports the Director of QA during regulatory and sponsor audits or inspections. The role includes reviewing study documents, drafting and revising policies and standard operating procedures, supporting deviation management, and helping study teams maintain Trial Master Files. The QAM also develops project risk review programs, performs root cause analyses, supports corrective and preventive action plans, and collaborates on process improvement and inspection readiness. The position reports to the Sr Project Manager and/or Project Director for a large global clinical study for assigned study operations. This role may be hybrid or potentially remote, requires reliable internet access, and may require onsite attendance for meetings, sponsor audits, or regulatory inspections. Travel on public roads and by air may be required, including occasional travel within the United States to audit investigational sites. The position is scheduled for 40 hours per week on the day shift.

Requirements

Bachelor's degree in a scientific, healthcare, clinical research, quality, regulatory, or related discipline; a bachelor's degree in a related field is required, and experience cannot substitute for the degree.
At least three years of experience related to clinical research, academic research, quality assurance, or a similar environment.
Strong time-management and organizational skills.
Excellent leadership, written communication, and verbal communication skills.
Understanding of clinical research methodology and regulations, including FDA, OHRP, and ICH guidelines and requirements, and ability to advise study teams on implementation.
Ability to identify problems and develop potential solutions.
Excellent computer skills, including Microsoft Office.
Ability to work independently and as part of a team in a fast-moving, deadline-driven environment while balancing multiple tasks.
Ability to make independent, effective decisions.
Ability to develop and manage positive relationships with sponsor representatives, study team members, and vendors.
Strong analytical, problem-solving, database management, and computer skills.
Ability to supervise and train staff effectively.
Aptitude for budget management.
Reliable access to the internet.

Nice To Haves

Master's degree in a related field.
One to two years of prior supervisory experience.
Background or familiarity with biology or another scientific discipline.
Experience with quality assurance in a clinical research setting.

Responsibilities

Implement tasks and quality initiatives outlined in the NCRI Quality Management Plan.
Prepare for and participate in external audits and inspections of NCRI by regulatory authorities and industry sponsors.
Assist in drafting responses to external audit findings.
Conduct onsite and remote site audits and draft reports documenting observations and follow-up action items.
Review NCRI staff adherence to written policies and procedures.
Review assigned project documents for compliance with institutional policies and procedures, good clinical practice, and regulations.
Revise NCRI policies and standard operating procedures.
Participate in system-level and protocol-level deviation management.
Collaborate with study teams to build, maintain, and audit Trial Master Files.
Develop and implement risk review programs for assigned projects.
Perform root cause analyses, implement corrective and preventive action plans, and conduct effectiveness checks.
Collaborate with functional teams on process improvement and inspection readiness following reviews, audits, and inspections.
Communicate effectively with NCRI ARO leadership and sponsors.
Advise and support NCRI staff on regulatory compliance and good clinical practices.
Accept responsibility for special projects as requested.
Collaborate with project investigators and research sites to meet study startup, site activation, recruitment, and enrollment targets.
Manage safety reporting to the FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies, and other regulatory bodies.
Collect, review, and approve required regulatory documents.
Manage multicenter trials funded by NIH and industry.
Collaborate with the grants management team to prepare progress reports.
Provide safety management oversight in collaboration with the study PI and safety boards.