Data Manager - Lead

Job Summary: This job is a great position for those continuing their career in clinical research and/or data management. 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 Medical Directors and the general supervision of the Program Manager for the Massachusetts General Bleeding Disorders 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 Bleeding Disorders 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.

Duties: Managing 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. Maintaining the center's American Thrombosis and Hemostasis Network (ATHN) database of our patient population in Clinical Manager, the Centers for Disease Control (CDC) repository for patient data collection required by the CDC.Provide back-up support for enrolling patients, conducting protocol related study visits, and data entry for studies conducted at the HTCMonitoring and reviewing data collection, entry, and other related activities to ensure protocol compliance and consistency Responsible for orienting and training new research staff on HTC research projects Maintaining regulatory documentation and site study files Manage study budgets, assisting with development of research budgets and reconciling payments for industry sponsored clinical trials. Coordinating activities at hospital to ensure correct testing/processing and send out instructions specific to the study Responsible for identifying new research projects, beneficial reports, and improving and streamlining research workflow Periodic testing of data validity, performing QA as well as identifying and resolving any errors or discrepancies. Responsible for completing annual reports as mandated by our HTC Region, ATHN/CDC, and Health and Human Services Administration (HRSA) Providing editorial support in designing and writing study protocols, designing study forms, and data reports. Conducting and coordinating qualitative/quantitative data analysis for projects as directed by medical directors and collaborating institutions. 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 sponsors Communicating project policies and procedures to personnel and third-party groups. Assisting with data gathering for other hemostasis and thrombosis related projects, such as surveys and patient reported outcomes. 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 Supports registration and updating of 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.Oversees the analyzing of HTC's quality improvement transition project data Oversees the blood sample collection process for all patients enrolled in CDC/ATHN related research studies. Generating reports to end users Opportunities to participate in lab/bench work as needed

Location: Mass General Hospital - 55 Fruit Street, Boston MAPlease note that this position does not support sponsorship for employment visa status or work authorization programs, including OPT and STEM OPT. Therefore, candidates requiring employment authorization visa through these programs are not eligible for consideration Remote Type Hybrid Work Location 32 Fruit Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay RangePay Range $79,560.00 - $115,720.80/Annual Grade 7EEO Statement1200 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. ValuesCombat disease. Hold a hand. Help people. Impact the world.

About Us: Mass General Brigham is a passionate, welcoming community where minds meet caring hearts. Come be a part of the world's most powerful force in medicine, where every role is important in changing lives. Our history includes New England hospitals founded over 200 years ago, some of the first and most prestigious hospitals in the world. Built on the legacy of two leading academic medical centers, we're more than a system—we're leaders in the practice of medicine. Mass General Brigham is committed to serving the community. We are dedicated to enhancing patient care, teaching and research, and taking a leadership role as an integrated health care system. We recognize that increasing value and continuously improving quality are essential to maintaining excellence.