Data Manager - Lead

Mass General Brigham•Boston, MA

2d•Hybrid

About The Position

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. Partner with aligned senior leaders to determine and plan for data analytics/reporting needs of a business unit or functional area(s). Mentor and train other data analysts. Identify trends, correlations, and anomalies in data and provide explanations or recommendations based on findings. Create clear, concise, and visually compelling data visualizations, dashboards, and reports. Present complex data and analytical findings in a meaningful and understandable manner to both technical and non-technical stakeholders. Performs comprehensive quality assurance, ensuring that data and reports meet end-user specifications and are accurate and reliable.

Requirements

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.
Prior experience with data management and/or the IRB/clinical research process is preferred
3-5 years of experience in Academic/Research Environment

Nice To Haves

Healthcare experience, particularly in an academic setting is a plus
Familiarity with EPIC and Data Management/Statistical software is a plus

Responsibilities

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 HTC
Monitoring 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