Clinical Data Manager - Res - G&C - CTSI Details

Clinical Data Manager - Res - G&C - CTSI

Tufts Medical Center - Boston, MA

Employment Type : Full-Time

Company Description

It takes a lot of very smart, hard-working and talented people to provide the level of care that we give to our patients. Tufts Medical Center is an internationally respected academic medical center and we pride ourselves not only on the sophistication of the care we deliver, but the compassionate way in which we provide it. And that starts with our employees.

Tufts CTSI (www.tuftsctsi.org/) is one of more than 60 organizations supported by the National Institutes of Health (NIH). The CTSA program was established in 2008 to transform the biomedical research process through education, promoting collaboration, and the provision of research infrastructure and support services. Tufts CTSI accelerates the translation of laboratory research into clinical use, medical practice, and health policy. In addition to its work with Tufts University, Tufts Medical Center, and other partners and collaborators, Tufts CTSI contributes to the national CTSA Consortium.

Tufts CTSI seeks an experienced Clinical Data Manager to partner with Project Managers, Principal Investigators, and Statisticians on the design, functionality, development, implementation, and validation of relational databases for single and multicenter clinical trials.

PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:

• Developing Electronic Case Report Forms, eCRF completion guidelines and edit checks, and trial Data Management Plans.
• Communicating with trial site staff regarding data submission and the resolution of data queries and performing descriptive statistical analyses.
• Leading daily data activities for assigned studies.
• Designing, developing, testing, validating, and managing Web-based EDC systems to support study outcomes.
• Supporting clinical research reporting for data review, quality-control edit checks, and interim and final analyses.
• Completing database cleaning and database locks and assisting biostatisticians with analysis file creation and statistical analyses.
• Providing educational support and training to investigators and study site coordinators for the development and implementation of research studies.
• Serving as credible expert/leader for data management best practices.
• Providing positive and effective customer service and contributing to teamwork within and between departments, divisions, programs and other organizations.
• Ensuring work is performed in conformance with established hospital, program, federal, and state policies and procedures.

JOB KNOWLEDGE AND SKILLS:

Analytical Skills:

• Knowledge of, and high proficiency in web-based Electronic Data Capture (EDC) and industry data standards (e.g., CDISC). Proficiency in other data management and statistical software (e.g., SAS, SQL) is desirable.
• Proven capability of attention to detail and accuracy.
• Knowledge of GCP guidelines and FDA regulations.
• Able to maintain positive and service-oriented culture under stress and deadlines.
• Flexible and able to adjust to shifting priorities in a fast-paced and dynamic work environment.
• Superior organizational skills: can prioritize and complete multiple simultaneous efforts with ease.
• Ability to work independently and as a part of a collaborative team.
• Knowledge of clinical and translational research is desirable.

General Skills:

• Written Communications: communicates clearly and effectively with internal and external customers.
• Oral Communications: Comprehends and communicates complex verbal information to medical center staff and external customers.
• Knowledge: Demonstrates working knowledge of standard concepts, practices, procedures and policies.
• Customer Service: Provides excellent customer service to staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Remains calm in stressful situations.

EDUCATION:

• A Bachelor’s or Master’s degree in data management, information technology, data analytics, data science, public health, or closely related field is required.

EXPERIENCE:

• At least 1 year of experience as a clinical data manager and with developing relational databases for clinical studies using REDCap and/or other EDC systems.
• An equivalent combination of education and experience, which provides proficiency in the areas of responsibility listed above, may be substituted for the above education and experience requirements.

WORKING CONDITIONS/PHYSICAL DEMANDS:

• Consistent with a typical office work environment. Work requires frequent typing/computer keying.

This is a grant-funded position through April 2023 with the strong possibility of renewal.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed, as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process improvements and business necessity.

All your information will be kept confidential according to EEO guidelines.

AMERICANS WITH DISABILITIES STATEMENT:

Must be able to perform all essential functions of this position with reasonable accommodation if disabled.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed, as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process improvements and business necessity.

All your information will be kept confidential according to EEO guidelines.