Quality Assurance Manager

Does this position require Patient Care?

No

Essential Functions

• Collaborating with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment.
• Safety management and reporting to FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies and other regulatory bodies.
• Collecting, reviewing and approving of all required regulatory documents; and working to ensure the study Trial.
• Managing multi-center trials funded by NIH, Industry standards.
• Collaborate with grants management team to prepare progress reports.
• Provide safety management oversight for studies, in collaboration with study PI and safety boards.

Qualifications

Education Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Progressively more responsible experience in a research related field 3-5 years required and Prior Supervisory Experience 1-2 years preferred Knowledge, Skills and Abilities - Strong organizational and communication skills. - Demonstrated analytical skills. - Effective problem solving skills. - Ability to supervise and train staff effectively. - Strong database management and computer skills. - Must possess aptitude for budget management.

Additional Job Details (if Applicable)

The Neurological Clinical Research Institute (NCRI), at Massachusetts General Hospital (MGH), is a premier Academic Research Organization (ARO) managing clinical research in neurological disorders. The NCRI employs multidisciplinary professionals dedicated to planning, implementation, oversight, and quality of clinical research.

The Quality Assurance Manager (QAM) will focus on regulatory and quality assurance aspects of clinical research. Under the supervision of a Senior Quality Assurance Manager, and provided with general direction by a QAM II, the QAM is responsible for implementing quality initiatives outlined in the NCRI Quality Management Plan (QMP) and ensuring NCRI staff are conducting research projects according to the QMP, regulations, good clinical practice guidelines and institutional policies and procedures.

The incumbent will audit clinical research projects coordinated by NCRI ARO. In addition, the QAM will support the Director of QA during inspections/audits of NCRI performed by regulatory agencies and industry sponsors. The QAM will perform internal reviews of NCRI staff adherence to written policies and procedures. The QAM will draft and revise NCRI policies and standard operating procedures (SOPs).

Principal Duties And Responsibilities

Relevant activities include, but are not limited to the following:

• Implement specific tasks as outlined in the NCRI Quality Management Plan, which defines QA functions, objectives, tracking processes, action plans, and identifies goals.
• Prepare for and participate in external audits/inspections of NCRI by regulatory authorities and industry sponsors.
• Assist with drafting responses to audit findings by external auditors.
• Perform on-site and remote site audits and draft audit reports with observations and follow-up action items.
• Perform internal reviews of NCRI staff adherence to written policies and procedures.
• For assigned projects, review project-related documents to ensure adherence with institutional policies and procedures, GCP, and regulations, including protocols, trial master file plans, training plans, quality management plans etc.
• Revise NCRI written procedures such as policies and SOPs.
• Engage in deviation management activities at the system-level and protocol-level.
• Collaborate with NCRI study teams to build, maintain and audit Trial Master Files (TMF).
• For assigned projects, develop and implement a risk review program.
• Perform root cause analyses, implement corrective action and preventive action plans (CAPAs), and perform effectiveness checks.
• Collaborate with Functional Teams on process improvement initiatives for inspection readiness following internal reviews, external audits/inspections, and have effective communication with NCRI ARO leadership and Sponsors.
• Act as a resource to NCRI staff and provide guidance/advice on regulatory compliance and good clinical practices, as needed.
• Accept responsibilities for special projects as requested.

Skills/Abilities/Competencies Required

• High level of time management and organizational skills.
• Excellent leadership, written and verbal communication skills.
• A solid understanding of clinical research methodology and regulations, including FDA, OHRP, and ICH guidelines and regulations related to the conduct of clinical research trials; and ability to advise study teams on how best to implement these regulations.
• Ability to identify problems and develop potential solutions.
• Excellent computer skills working with Microsoft Office.
• Team player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously.
• Ability to make independent, effective decisions.
• The ability to develop and manage positive relationships with sponsor representatives, study team members, and vendors.

Education

Bachelor's degree in a scientific, healthcare, clinical research, quality, regulatory, or related discipline.

Experience

Required

• A minimum of three (3) years of working experience related to clinical research, academic research, quality assurance, or a similar environment is required.

Preferred

• Background/familiarity with biology or other scientific discipline is preferred, but not required.
• Experience with Quality Assurance in a clinical research setting is preferred, but not required.

Working Conditions

This position can be either hybrid or potentially remote. Must have reliable access to internet. On occasion and at the discretion of the Director of QA, the QAM may be required to be onsite for meetings, sponsor audits or regulatory inspections. Advanced notice will be given.

Will travel on public roads and air travel as needed. On occasion, the QAM may be required to travel within the United States to audit investigational sites at the discretion of the Director of QA.

Remote Type

Hybrid

Work Location

399 Revolution Drive

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

$63,252.80 - $102,596.00/Annual

Grade

7

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

EEO Statement

1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.