For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Essential Functions:
- Design, develop, implement, maintain, and support clinical database systems.
- Offer technical expertise for internal and external clients.
- Code, test, and document databases as per programming standards and clinical validation policies.
- Program database manipulation and conduct data transfers for clients.
- Review Data Validation Plans and Case Report Forms as per area of expertise.
- Add all external data sources such as PK and central lab within the clinical database if integration is requested or required.
- Serve as programming contact to handle database issues within area of expertise.
- Support development and implementation of new technologies.
- Support Information Technology to evaluate new technology upgrades by participating in software change controls.
- Support development, revision and maintenance of core operating procedures and working instructions pertaining to database development, user acceptance testing and change controls.
- Interface with project team to organize responsibilities and deliverables.
- Establish effective communication and professional relationships with teams and external vendors.
- Interface with Clinical Data Management and corporate team to negotiate timelines.
- Perform administrative tasks within the EDC system, such as site and user management, URL level reviews and/or approvals, and dictionary updates.
- Follow and influence the development of data standards and strategies pertaining to the standards library.
Qualifications:
- Understanding of the principles of ICH GCP and regulatory requirements is essential.
- Excellent organizational and analytical skills, strong oral and written communication skills, and able to work in a high paced, timeline driven setting.
- Minimum BS in a scientific or health related field or equivalent in years of experience.
- Minimum 3 years of experience as a clinical database developer.
- Experience with EDC system Medidata Rave.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
What We Do
ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies.
With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science
