Quality Assurance Manager

Site: The General Hospital Corporation

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

The Neurological Clinical Research Institute (NCRI) at the Massachusetts General Hospital (MGH) is a premier Academic Research Organization (ARO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, research nurses, quality specialists, and administrative assistants dedicated to planning and implementing clinical trials.

The Quality Assurance Clinical Trial Project Manager (QAM) will focus on regulatory and quality assurance aspects of clinical research. Receiving general direction from the NCRI Director Quality Assurance (QA) and 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 of NCRI by regulatory authorities and industry sponsors.
• Lead/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.
• Develop new/revise NCRI written procedures, such as policies and SOPs.
• In collaboration with Functional Teams, select and manage vendors contracted by NCRI.
• Assist with pre-qualification and periodic audits of vendors contracted by NCRI.
• 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.
• Develop and review corrective action and preventive action plans (CAPAs) and perform effectiveness checks.
• Collaborate with Functional Teams and QAM II 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 AND COMPETENCIES:

• 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 the 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.

EXPERIENCE:
Required:

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

Preferred:

• Background/familiarity with biology or other scientific disciplines is preferred, but not required.
• Experience with Quality Assurance in a clinical research setting is preferred, but not required.
• Previous experience in quality auditing, both internal and external, is preferred, but not required.

WORKING CONDITIONS:
This position can be either hybrid or remote. Must have reliable internet access. On occasion and at the discretion of the Director of QA, the QAM may be required to be on-site 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

Job Summary

Summary
The position reports directly to the Sr Project Manager and/or Project Director of a large global clinical study. This position has management responsibility for specific roles within a clinical study assigned to support the day-to-day operational project management of assigned trial(s).

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.

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)

Hybrid

399 Revolution Drive

40

Regular

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.

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.

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