DeltaMed Solutions, Inc. (DMS), as a CRO company, specializes in data management, biostatistics, and SAS programming. Our clients and partners include pharmaceutical, biotechnology, medical device companies, and CROs.
Striving for high quality, we focus on reducing the time, cost, and risk of bringing new pharmaceutical products to market. Our knowledge, experience, passion for what we do, and commitment to excellence are our products and our business.
We are currently looking for a qualified Summer Data Manager/Coordinator Internto join the data management team using established guidelines and tools to perform data review and manage data quality for on-going clinical trials.
Please do not apply unless you are local to our Somerset, NJ office and can work onsite part of the week. This position is a 10 week program that will start in June and extend through the beginning of August. It is a paid position that can lead to permanent employment.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Learn the basic knowledge of the clinical trial process, including new drug development and how Data Management supports this.
2. Become familiar with:
a. Process and tools utilized by Data Management.
b. Data Management documents: such as, Data Management Plan, Data Validation Plan, and Data Entry Instructions.
c. Standard Operating Procedures (SOPs), Regulatory Requirements, and Good Clinical Practices (GCPs) with regard to data management.
d. Data collection forms and database design.
e. Handling External Data Transfers and Medical terms coding process.
3. Be guided to participate in the:
a. Validation of data entry screens in a clinical database, as well as, edit check programming.
b. Clinical data review of data collected in the clinical database – electronic Case Report Forms (eCRFs).
c. Collaboration with other study team members, and learn about their roles and responsibilities in supporting clinical studies along with Data Management.
ESSENTIAL KNOWLEDGE, SKILLS AND EXPERIENCE
1. B.S. or M.S. in Data Science, Nursing, Health Administration, Biostatistics, Computer Science, or other related fields.
2. Basic analytical skills with a desire to gain experience in data management of clinical research in pharmaceutical, biotech, or CRO environment.
3. Good communication and writing skills.
4. Ability to work in a team environment.
5. Attention to detail and quality driven.
6. Experience with Microsoft Office software (Word, Excel, PowerPoint)
Job Type: Internship
Schedule:
- 8 hour shift
Work Location: Hybrid remote in Somerset, NJ 08873