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Clinical Manager
3 months ago
Clinical Systems Manager - Fully Remote
Schedule: Monday - Friday, any time zone
Location: Anywhere in the US
Long Term Contract
CornerStone TTS is seeking a Clinical Systems Manager for a remote, full-time position. The Clinical Systems Manager (IRT) will collaborate with a cross-functional team of internal stakeholders (such as Clinical Study Management, Supply Chain, and Data Management) and technology suppliers to support the implementation and maintenance of IRT solutions for clinical trials. The Clinical Systems Manager will provide technical oversight to ensure that IRT solutions align with study protocols, industry regulations, best practices, and company policies and guidelines.
**Successful Candidate:**
* Must have experience with systems integration related to IRT systems.
* IRT stands for Interactive Response Technologies.
* Experience in Pharma, Biotech, or as a supplier is required.
* Must have experience in designing or maintaining IRT systems for clinical trials.
* Experience in negotiating with external vendors, project and personnel management, and documentation in regulated environments.
* Clear communicator with a positive attitude.
* Familiar with providing premium support to IRT users internally and externally.
* Highly knowledgeable and able to demonstrate expertise through experience.
* Capable of leading projects within tight deadlines.
**Basic Qualifications:**
* Doctorate Degree
OR
* Master’s Degree with 2 years of IRT experience
OR
* Bachelor’s Degree with 4-5 years of IRT or clinical experience
OR
* Associate’s Degree with 10 years of IRT experience
OR
* High School Diploma/GED with 12 years of IRT experience
**Preferred Qualifications:**
* Over 5 years of focused IRT experience
* Bachelor’s Degree in life science, computer science, engineering, business, or a related field
* More than 4 years of experience in clinical operations, clinical supply chain, or clinical systems management
* Experience in implementing clinical systems such as IRT and eCOA
* Knowledge of Good Clinical Practices and FDA regulations for clinical trial execution
* Detail-oriented with the ability to manage multiple projects simultaneously
* Strong documentation and communication skills
* Proficient in meeting management and facilitation
* Experience in vendor management
* Excellent time management and organizational skills in a deadline-driven environment
* Strong problem-solving, judgment, and decision-making abilities
* Ability to work well in a team-based environment with minimal supervision