At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
We are seeking a dynamic Senior Manager, Clinical Systems, to join our Clinical Informatics & Analytics team. This individual will be responsible for partnering with cross functional stakeholders and decision makers to enhance DICE’s capabilities and utilization of clinical systems like eTMF, CTMS and EDC. Including support for collection of business requirements for new clinical systems and enhancements to existing systems, planning release and execution, and risk and issue management. Serve as Business System Administrator for Clinical Systems.
This position will represent the Clinical Informatics & Analytics team in internal and external meetings involving management and operation of the Clinical Systems. Interfaces with CROs, Clinical Operations, IT, QA, and other functional groups throughout DICE to optimize system delivery and resolve any issues. And ensures management and operation of the clinical systems are in compliance with DICE’s SOPs and policies.
- Develops, maintains, and oversees applicable SOPs, WIs and templates to ensure that clinical systems operations are performed in adherence with ICH/GCP/regulatory guidelines and established best practices
- Serves as the DICE representative in matters related to deployment of clinical systems in relation to DICE clinical studies. Including oversight of project timelines and quality.
- Partners with IT and QA to support implementation and testing of new systems or upgrades of existing systems.
- Leads and/or participates in departmental initiatives to help streamline and standardize processes and systems.
- Performs business system administration responsibilities of DICE’s Clinical Systems. This includes but not limited to:
- Developing and managing timelines for the project / study level system administration
- Managing clinical systems support resources as required
- Manages data import and export activities to and from clinical systems
- Ensures compliance with ICH6 R2/R3 risk management and data integrity requirements for all Clinical Systems when serving as the business system administrator
- Oversee user access request activities (user additions/changes/deactivation), including periodic reviews.
- Identifies, develops, and executes the business process improvement opportunities and identifies new clinical systems for the organization
- Provide training and support to end users on business process and system use.
- Liaise with internal stakeholders and system vendor in troubleshooting and resolving system issues.
- Participate in system change controls, including user acceptance testing
Preferred Experience and Education:
- Bachelor’s degree in Computer Science/Information Technology/Bioinformatics
- Knowledge of regulatory guidelines, including GCP/ICH, FDA/EMA, 21 CFR Part 11, validation requirements
- Comprehension of the Product Life Cycle of software products
- Understanding of technical requirements and setup of SaaS solution
- Ability to transform business needs into technical requirements
- Excellent problem solving, negotiation, resource allocation and organizational skills
- 8+ years working in the pharmaceutical, biotech industry
- At least 3 years of experience working in a business system administrator role in SaaS clinical system like eTMF, CTMS, EDC etc.
- Experience leading technical projects
- Demonstrated experience collaboration with cross-functional teams
- Experience with and understanding of clinical trials and clinical data.
Preferred Additional Skills:
- Thorough scientific record keeping
- Strong organizational and time-management skills
- Excellent written and oral communication skills
- Team player; comfortable and effective in a collaborative research environment
Salary range 165k – 180k (Bay Area)
The pay range for this position that we reasonably expect to pay. Individual compensation is based on various factors including, experience, education, skillset, and geographic location. This range is for the Bay Area, California location and may be adjusted to the labor market in other geographic areas.
DISCLAIMER The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.