Clinical Data Management Operations Advisor
Santa Cruz, CA
The Clinical Data Management Operations Advisor provides leadership and strategies to our clients by advising internal and external stakeholders on clinical data management technologies, processes, and standards.
The position requires significant skills in continuous improvement, project management, change management, and risk management. Additionally, the advisor will leverage interpersonal skills, and extensive clinical trials experience to mentor clients on clinical data management practices.
A successful advisor leverages interpersonal skills, and extensive clinical trials experience to mentor clients on clinical data management practices. Additionally, she possesses advanced knowledge of clinical operations and relevant regulatory requirements.
This position has solid verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures.
Role and Responsibilities
- Direct/Manage/Supervise the planning and execution of clinical data management activities, systems, and processes.
- Develop Standard Operating Procedures associated with data collection, handling, review, and transfer.
- Oversee the development and maintenance of data-related documentation, such as data management plans, case report forms, data flow, and integrity plans, and data review plans.
- Provide strategic guidance in the collection, cleaning, and auditing of clinical data. Ensure the highest levels of data quality and compliance are achieved.
- Provide technical direction in database design specifications and deployment. · Collaborate cross-functionally to align clinical data management operations with business plans and objectives.
- Oversight on data manager set-up and specific team member tasks
- Oversight on the internalization of data management tasks from external vendors.Education Requirements
- Bachelor’s degree from an accredited college or university; MS/BS in life sciences or related field (MS preferred).Experience
- Minimum of 10 years of clinical data management experience in a medical device or pharmaceutical company, or similar environment (e.g., CRO) · 5+ years of combined experience managing people or initiatives
- Experience running clinical trials outsourced to a CRO as well as managed in-house
- Expert business knowledge with a comprehensive understanding of the organization and functional area(s).
- Experience with handling data for Data Safety Monitoring Boards (DSMB), Independent Data Monitoring Committees (iDMC), Safety Review Committees (SRC), and Dose Limiting Toxicity committees (DLT).
- Extensive knowledge of Electronic Data Capture, related applications, and industry standards Preferred Skills
- Proficient in working with data received from CROs and other third-party vendors
- Knowledgeable in GCP, CDISC standards, clinical trial guidelines & Data Management Best Practices
- Ability to ‘wear many hats’, and self-motivated to take on new challenges
- Track record of success in a deadline-driven and multi-task environment
- Well organized and detailed oriented