Clinical Operations Manager
NTT DATA Services strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.
We are currently seeking a Clinical Operations Manager to join our team in Rockville, MD, USA..
NETE is seeking a highly motivated, flexible, organized, and detail oriented Clinical Operations Manager to join our team. If you want to learn, grow, and help then this is the job for you. We support a project/customer that "seeks fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability." What you do matters and has significant impact on the medical and scientific communities we serve.
The Clinical Operations Manager will be part of the data management and programming team. He/she will work with international clinical research study teams and will be engaged in a variety of tasks that will involve the programming, delivery and support of clinical databases intended for clinical research programs.
- Lead clinical studies with moderate guidance as well as monitor the progress of data management activities. Additionally responsible for providing regular status reporting on data management progress.
- Review protocols for appropriate data capture tools including Case Report Form (CRF) design.
- Interact with data entry/review team members, programmers, study managers and statisticians in designing CRFs (and eCRFs) and creating the annotated CRF and CRF completion guidelines.
- Develop data edit check specifications and run data listings as required.
- Develop the Data Management Plan for a clinical study.
- Enter data queries into the CDMS to be resolved at investigational sites and manage the resolution of those queries.
- Perform database lock and freeze activities per SOPs.
- Participate in regular team meetings and provide input when appropriate.
- Work with study teams to define requirements to create database schema and to implement quality control programming and edit checks.
- Provide programming support for clinical data management and reporting for clinical studies.
- Generate and maintain all required documentation, including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding setup, edit check procedures, import/export setup and processing under the general direction of the international IT program manager.
- Will also promote staff training and development; and is responsible for general system administration and service quality management.
Location: Rockville, MD
- Bachelor's degree in computer science, statistics or related field, and nominal experience particularly in clinical programming and relational database development, or equivalent education and experience, required.
- At least 3 to 5 years of experience with Clinical Data Management experience, programming proficiency in Electronic Data Capture (EDC) and data reporting, and/or transformation languages, e.g., SAS, C#, R, or comparable.
- Experience with regard to the application of CDISC standards to clinical research databases.
- At least 3 to 5 years of experience with advanced database programming. (Setup and programming skills specifically for the CDMS DataFax would be highly advantageous).
- At least 3 to 5 years of experience working as part of an interdisciplinary team on biomedical research projects, specifically with clinical trials.
- SAS and/or R programming skills would be highly advantageous.
- Must have great customer service skills to support clinical research.
- Excellent oral and written communication skills.
- Proficiency in Word, Excel, and PowerPoint.
- Must know and understand the application of HIPAA regulations within clinical research.
- Must know and understand the application of Good Clinical Practice.
- Setup and programming skills specifically for CDMS DataFax, advantageous.
- Proficiency with French and/or Chinese, desired.
- Experience with data visualizations using tools such as Tableau or Qlikview, desired.
- Applicants selected will be subject to a Public Trust background security investigation and may need to meet eligibility requirements for access to sensitive information. US Citizens or Permanent Residents preferred.
In compliance with theColoradoEqual Pay Transparency Rules, NTT DATA provides a reasonable range of compensation for roles that may be hired inColorado. For a candidate in the state of Colorado only, the starting pay range for this role is $125k to $170k. Actual compensation will depend on a number offactors, including actual work location, relevant experience (internal or external), technical skills, and other qualifications.
About NTT DATA Services
NTT DATA Services is a global business and IT services provider specializing in digital, cloud and automation across a comprehensive portfolio of consulting, applications, infrastructure and business process services. We are part of the NTT family of companies, a partner to 85 % of the Fortune 100.
NTT DATA Services is an equal opportunity employer and considers all applicants without regarding to race, color, religion, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other characteristic protected by law. We are committed to creating a diverse and inclusive environment for all employees. If you need assistance or an accommodation due to a disability, please inform your recruiter so that we may connect you with the appropriate team.
Your application has been successfully submitted.