Clinical Data Manager
Department: Data Management
The individual will be able to work remotely anywhere in the United States.
DF/Net Research provides data management, biostatistics, and software development services for industry, non-profit, and academic organizations worldwide. Since 2004, DF/Net’s people, products, and services have helped our global clients with over 100 Phase I through Phase IV clinical trials. Our focus is global health. DF/Net helps researchers manage and analyze data across 18 therapeutic areas with clinical sites in over 35 countries. Our work includes HIV, TB, Malaria, Ebola, and other tropical diseases. We recently began managing data for COVID-19 Trials. Our motto is “helping people help people on a global scale.” In our supporting role, we are fortunate to work with some of the world’s top research scientists who have dedicated their lives to challenging global health issues
DF/Net is seeking a Clinical Data Manager with experience in clinical trials to support our growing company. The ideal candidate has an advanced degree related to Public health or related field and experience with DF/Net’s proprietary software, clinical trial data and research studies. A suitable candidate could also have experience with another Clinical Data Management System. He or she will be committed to high quality standards and ensuring DF/Net leverages industry best-practices in clinical data management and CDISC solutions to provide accurate and meaningful results to our clients.
Applies knowledge of health care and project management skills, with a high level of technical skill, to clinical data management responsibilities from study development through study closure, including CRF creation, study database setup, testing, and documentation; internal and external study team training; data collection, tracking, and cleaning; study closeout activities; and overall project management. Liaising with study sponsor or client to understand needs and provide appropriate advice and guidance when needed.
Participate in company software and infrastructure development. Provide training and mentoring to Clinical Data Coordinators and more junior Clinical Data Managers.
Essential Duties and Responsibilities:
- Perform as a liaison for the study sponsor and collaborators.
- Provide appropriate advice and guidance to study sponsor or client as needed.
- Translate protocol requirements into data collection instruments.
- Maintain and monitor Clinical Data Management study timelines.
- Coordinate with Data Sciences team.
- Collaborate within study team.
- Train and mentor Clinical Data Coordinators and more junior Clinical Data Managers.
- Develop and provide written and oral presentations as needed.
- Develop Case Report Forms (eCRFs/CRFs).
- Define and test databases.
- Develop edit checks.
- Develop study specific Data Management Plans, maintain study documents.
- Perform and document study closeout activities.
- Manage data quality control activities.
- Validate data, review data queries, and generate QC reports.
- Contributing to the development of more effective processes within the department.
- Perform additional study and projects, as needed.
- Maintain a consistent work schedule in accordance with departmental and company expectations.
- Comply with industry regulatory requirements and standards and DF/Net Research Standard Operating Procedures (SOPs).
- Bachelor's degree in Public health or related field.
- Experience with clinical trial research and/or database management.
- Knowledge of clinical trial activities and Good Clinical Data Management Practices.
- Master’s degree or equivalent experience.
- At least four years of experience with DF/Net’s proprietary software or another Clinical Data Management System.
- At least four years of experience with clinical trial data or research studies.
- Experience with Electronic Data Capture (EDC).
- Experience with international clinical trials.
- Knowledge of FrameMaker.
- Familiarity with CDISC standards.
Knowledge, Skills and Abilities
- Demonstrated ability to multi-task and appropriately prioritize work assignments.
- Ability to work independently.
- Ability to work collaboratively in a physical or virtual team environment.
- Flexibility to work in changing research environment.
- Exceptional attention to detail.
- Proficient computer skills.
- Management skills.
- Strong verbal and written communication skill.
- Sitting for prolonged periods of time.
- Repetitious computer usage.
- Regular office environment or regular remote office environment.
- Occasional travel, including international, based on projects assigned.
This job description is not a comprehensive listing of the duties or of this job. These may change at any time with or without notice.
Our work culture strives for an environment of collaboration, integrity, forward-thinking, creativity, and caring. Our benefits include medical, dental, vision, life insurance, long term disability, and 401k with company matching. We provide paid vacations, holidays, flexible work hours and a telecommute possibilities.
The company does not sponsor temporary visas (e.g. H1B, F1, EAD, OPT, etc.). Candidates are required to have unrestricted legal authorization to work in the United States without the need for sponsorship now or in the future. (e.g. US Citizen, US permanent resident, etc.).
If you are interested in this position and feel that you are qualified to perform indicated duties, please send your resume and cover letter to firstname.lastname@example.org.