- DZS Clinical Services, Inc.
- Monmouth Junction, NJ
DZS Clinical Services provides full-service clinical development capabilities and data analytics solutions to execute global clinical trials. Our organization focuses on utilizing technology solutions with an emphasis on data integrity.
We are a growing, global CRO looking for dynamic individuals with an interest in bringing their unique skills to support the development of new treatments for patients.
This role will be responsible for all aspects of the clinical data management and programming department. Responsibilities will include resourcing for projects, tracking budgets, participating in business development activities, and developing proposals. Other activities may consist of mentoring junior staff and overseeing or co-performing (when necessary) database set-up, data cleaning, and statistical programming, including quality review processes for assigned projects. The position will have direct reports.
Duties & Responsibilities:
- Ensure Data Analytics projects are resourced appropriately;
- Participate in new business development opportunities;
- Develop and oversee project budgets;
- Support the growth of the business by suggesting process improvement ideas and improving services;
- Work with QA to ensure functional areas are producing high-quality deliverables consistently;
- Be responsible for coordinating, facilitating, and (at times) participating in data management and statistical programming activities from initiation of protocol, study startup through database lock;
- Support CRF design, review, and validation of clinical databases;
- Contribute towards process improvement, data standards, and initiatives within data management as needed;
- Have the ability to support several moderate/complex trials with minimal supervision;
- Be responsible for the creation of data management plans and other data management documentation as needed with minimal oversight;
- Monitor progress and conduct of DM projects, including all data cleaning, data programming and QC activities to ensure all remain on target to project timelines;
- Have the ability to supervise direct reports.
Functional and Technical Competencies
- Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc.);
- Knowledge of GCP/GCDMP and other regulatory requirements regarding clinical data management documentation and software;
- Experience with Electronic Data Capture (EDC);
- Experience with CDISC standards;
- Knowledge of other eClinical Technology including eTMF, CTMS, etc.;
- Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).
Education and Experience Requirements:
- A Bachelor's degree (or equivalent) in the biological sciences, computer science, or related discipline is preferred;
- At least seven years of clinical data management or programming experience preferred.
Job Type: Full-time. This position can be remote, hybrid, or in-office (2-3 days/week preferred).
- Dental insurance
- Employee assistance program
- Flexible schedule
- Health insurance
- Health savings account
- Paid time off
- Vision insurance
- Bonus available based on company and individual performance
Please contact email@example.com for more information.
Applicants can send a cover letter and CV to Greg Ambra at firstname.lastname@example.org.