Clinical Research Data Manager I

Job ProfileSummary​This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes.In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation.  Includes Clinical roles focused on research projects.  Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community.A professional individual contributor role that may direct the work of otherlower levelprofessionals or manage processes and programs.The majority oftime is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typicallyacquiredthrough advanced education.A senior level role that requires advanced knowledge of job area typically obtained through advanced education and work experience.Typicallyresponsible for: managing projects / processes, working independently with limited supervision,coachingand reviewing the work oflower level professionals, resolving difficult and sometimes complex problems.Job OverviewThe Center for Clinical Trials at Tufts CTSI and Tufts Medical Center isan academic data coordinating center supporting investigator-initiated multisite clinicaltrials. The Clinical Research Data Manager I will be an integral member of the datamanagement team, working closely with principal investigators, senior data manager,project managers, and biostatisticians to support the operationalization of clinical trialprotocols into high-quality electronic data systems.This role requires hands-on proficiency with REDCap and core clinical trial datamanagement workflows. The Data Manager will work within established datacoordinating center processes to support protocol-driven database design, REDCapEDC build and testing (including branching logic, calculated fields, and automatednotifications), and ongoing data quality control activities. The position emphasizesrigorous execution, attention to detail, and accountability for assigned day-to-day datamanagement tasks, including supporting query resolution, data cleaning, and assistingwith the preparation of analysis-ready datasets in compliance with GCP and institutionalstandards.Minimum Qualifications:1.Bachelor’sdegree in health science, public health, epidemiology, oranother related fieldincludingcoursework in biostatistics or computerized analytic techniques.2.Three (3)years of experience as a clinical data managerincludingdeveloping relational databases for clinical studies usingREDCapand/or commercially available EDC systems.Preferred Qualifications:1. Experience assisting in the build and management of REDCap databases2. Experience translating protocols into schedules of events, CRFs, and databasespecifications3. Experience supporting data quality control, query generation and resolution, anddatabase cleaning and lock, under supervision4. Experience assisting with the preparation of analysis-ready datasets andcollaborating closely with biostatisticiansDuties and Responsibilities:Theduties and responsibilities listedbeloware intended to describe the general nature of workandare not intended to be an all-inclusive list.Other dutiesand responsibilitiesmay be assigned.1.Develops Electronic Case Report Forms, eCRF completion guidelines and edit checks, and trial Data Management Plans.2.Communicates with trial site staffregardingdata submission and the resolution of dataqueries, andperforming descriptive statistical analyses.3.Leads daily data activities for assigned studies.4.Designs, develops, tests,validates, and manages Web-based EDC systems to support study outcomes.5.Writes and implements data management plans, data entry guidelines, and data completion guidelines in compliance with Standard Operating Procedures, Good Clinical Practice (GCP) guidelines, and FDA requirements, if applicable.6.Supports clinical research reporting for data review, quality-control edit checks, and interim and final analyses.7.Completes database cleaning and databaselocks, andassistingresearch biostatisticians with analysis file creation and statistical analyses.8.Provideseducational support and training to investigators and study site coordinators for the development and implementation of research studies.9.Mentors data management/entry staff andprovidingproject management support.10.Serves as credible expert/leader for data management best practices.11.Establishespriorities and strategies for resource development and core goal setting.12.Providespositive and effective customer service andcontributingto teamwork within and between departments, divisions,programsand other organizations.13.Ensures work is performed in conformance with establishedhospital,program, federal, and state policies and procedures.Physical Requirements:1. This islargely asedentary role, which involves sitting most of the time, but may involve movements such as walking, standing, reaching, ascending/descending stairs, and operating office equipment.2. Frequentlyrequiredto speak, hear, communicate, and exchange information.3. Ability to see and read computer displays, read fine print, and/or normal type size print and distinguish letters,numbersand symbols.4. Requires manual dexterity using fine hand manipulation tooperatecomputer keyboard.Skills & Abilities:1.Analytical skills.2.Knowledge of, and highproficiencyin, Electronic Data Capture (EDC) and industry data standards (e.g., CDISC).3.Proven capability of attention to detail and accuracy.4.Knowledge of GCP guidelines and FDA regulations.5.Abilitytomaintainpositive and service-oriented culture under stress and deadlines.6.Flexible and able to adjust to shifting priorities in a fast-paced and dynamic work environment.7.Superior organizational skills: can prioritize and complete multiple simultaneous efforts with ease.8.Ability to work independently and as a part of a collaborative team.9.Knowledge of clinical and translational research.10.Proficiencyin other data management and statistical software (e.g, SAS, SQL,web basedEDC) is desirable.At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day.The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals.Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth—one of the many ways we invest in you so you can thrive both at work and outside of it.Pay Range:$55,883.46 - $69,859.61