Clinical Data Manager Full Time

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.

Job Summary

This job is a great position for those starting your career in clinical research and/or data management as well as pre-medical graduates. The occupant will interact with patients, learn many relevant medical concepts pertaining to bleeding and clotting, and have opportunities to work in both clinical and laboratory projects, according to their interests and availability.

The successful applicant will work under the direct supervision of the Clinical Data Manager and the general supervision of the two medical directors for the MGH Comprehensive Hemophilia and Thrombosis Treatment Center. They will support the management and operations of clinical and translational research projects. Duties include maintenance and retrieval of study data, implementation of study protocols, management with study regulatory matters.

The individual will also serve as a vital member of the Hemophilia Treatment Center team responsible for coordination, integrity, and management of patient databases for the program. The successful applicant will serve as a liaison with national and regional study coordinating centers and with other participating treatment sites.

Essential Functions

• Collates, models, interprets, and analyzes data.
• Explains variances and trends in data.
• Identifies and documents enhancements to modeling techniques.
• Completes thorough quality assurance procedures, ensuring accuracy, reliability, trustworthiness, and validity of work.
• Performs data validation of source-to-target data for data visuals and dashboards.

Qualifications

Education

• Bachelors degree required
• Equivalent experience may be considered in lieu of degree

Experience

• Experience working with data, preferably healthcare data 2+ years required
• 1-2 years of experience in Academic/Research Environment
• Prior experience with data management and/or the IRB/clinical research process is preferred

Skills/Abilities/Competencies Required

• Analytical skills to collect information from diverse sources, apply professional principles in performing various analyses, and summarize the information to solve problems.
• Excellent English language skills for writing, editing, and proofreading
• Excellent communication skills and sensitivity to confidentiality issues; diplomacy and discretion.
• Ability to handle multiple tasks simultaneously, prioritize, and meet deadlines.
• Ability to work collaboratively as part of a team
• Proficiency with multiple software applications, including Microsoft Office suite, database programs, and medical records programs such as EPIC.
• Healthcare experience, particularly in an academic setting is a plus
• Familiarity with EPIC and Data Management/Statistical software is a plus

Duties And Responsibilities

• Registers and updates patient information on American Thrombosis and Hemostasis Network (ATHN) systems. Submitting surveillance data on demographics, bleeding, and clotting events of the MGH Hemophilia Treatment Center’s (HTC’s) patient population to ATHN and the CDC.
• Consenting patients with relevant bleeding disorders for the CDC Community Counts registry, ATHN studies, industry sponsored studies, and local projects.
• Maintain clear, accurate, and up to date records of patient study notes, including documentation of the informed consent process
• Conducting protocol related in-person/virtual visits with study participants. Completing, collecting, and tracking of all study forms.
• Assisting medical providers with organizing clinic visits, as needed, and identifying eligible patients for studies and the consent process.
• Attend monthly study site management meetings with study sponsors
• Communicating project policies and procedures to personnel and third-party groups.
• Periodic testing of data validity, performing QA as well as identifying and resolving any errors or discrepancies.
• Assisting with other administrative/planning/reporting tasks and requirements as mandated by our HTC Region, ATHN/CDC, Health and Human Services Administration (HRSA), or specific needs by the clinical research team
• Analyzing HTC’s quality improvement transition project data
• Maintain email list for HTC’s bleeding disorder patients
• Assisting with data gathering for other hemostasis and thrombosis related projects, such as surveys and patient reported outcomes.
• Managing the blood sample collection process for all patients enrolled in CDC/ATHN related research studies.
• Generating reports to end users
• Pulling data and providing clean datasets to end users
• Participating in formal and informal presentations of protocols and results to staff. May also collaborate in preparing articles for journal publications and making presentations at conferences and meetings.
• Attending/conducting meetings, teleconferences, and webinars relevant to current or upcoming research and clinical projects
• Assist providers with the life cycle of establishing vendor/third party contract requests to invoicing for services
• Participate in lab/bench work as needed
• Support the HTC’s clinical research development processes from study start up to close out, including Institutional Review Board (IRB) submissions, third party grants/agreements submissions, and other regulatory matters.
• Maintain the center’s ATHN database of our patient population in Clinical Manager, the Centers for Disease Control (CDC) repository for patient data collection required by the CDC.
• Serve as a liaison with sponsors, IRB, core laboratories, site PIs, and study staff for all clinical research related matters
• Monitor and review data collection, entry, and other related activities to ensure protocol compliance and consistency
• Assist with the maintenance of regulatory documentation and site study files
• Manage study budgets, assisting with development of research budgets and reconciling payments for industry sponsored clinical trials.
• Coordinate activities at hospital to ensure correct testing/processing and send out instructions specific to the study
• Identify new research projects, beneficial reports, and improve research workflow
• Complete annual reports as mandated by our HTC Region, ATHN/CDC, and Health and Human Services Administration (HRSA)
• Provide editorial support in designing and writing study protocols, designing study forms, and data reports.
• Support qualitative/quantitative data analysis for projects as directed by medical directors and collaborating institutions.

Working Schedule

Additional Job Details (if applicable)

• Hybrid, 32 hours per week
• Location: Mass General Hospital – 55 Fruit Street, Boston MA

Remote Type

Hybrid

Work Location

32 Fruit Street

Scheduled Weekly Hours

32

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

$63,648.00 – $90,750.40/Annual

Grade

6

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.