Position Summary:
The Senior/Principal Clinical Database Manager is responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications. Position will interface directly with the internal team (i.e. Data Management, Project Management, etc.), EDC vendor, clients and third-party vendors to gather requirements and provide status updates. Provides operational and technical training to end users and junior staff. Additionally, the Senior/Principal Clinical Database Manager may play a lead role in internal software projects that require specialized programming and/or scripting.
Qualifications:
Minimum Required:
- Must have experience in developing and customizing clinical data management databases in a clinical, scientific or health care discipline
- Bachelor’s and/or a combination of related experience
- Medidata Rave EDC Certified Study Builder
- Rave API integration experience using external vendor modules
- Rave Advanced Custom Function programming experience
Other Required:
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
- Able to handle a variety of clinical research tasks.
- Excellent organizational and communication skills
- Professional use of the English language; both written and oral.
- Experience in Object Oriented Programming (C#, C++, VBS, etc.…), scripting language (PERL, etc.), SAS, R, SQL
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
- Experience in clinical database management system development.
- Experience in a clinical, scientific or healthcare discipline.
- Experience in utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Strong leadership and interpersonal skills
- Must be able to communicate effectively in the English language.
Preferred:
- Oncology and/or Orphan Drug therapeutic experience
- Base SAS®, SAS/STAT and SAS/ACCESS software
- SAS Macro programming language
- Advanced experience in Database Management, object-oriented programming
- Veeva set up experience
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
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What We Do
Precision is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. This maximizes our clients’ insight into patient biology, delivering more predictable trial outcomes and accelerating clinical development. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.
