Clinical Data Manager

Mass General Brigham • Boston, MA

2d • Hybrid

About The Position

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.

Requirements

• Bachelors degree required
• Equivalent experience may be considered in lieu of degree
• Experience working with data, preferably healthcare data 2+ years 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.

Nice To Haves

• 1-2 years of experience in Academic/Research Environment
• Prior experience with data management and/or the IRB/clinical research process is preferred
• Healthcare experience, particularly in an academic setting is a plus
• Familiarity with EPIC and Data Management/Statistical software is a plus

Responsibilities

• 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.
• 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.

What This Job Offers

• Job Type: Part-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees