VP of Clinical Information Technology
United States, Remote
Sanguine Biosciences is accelerating personalized medicine research by empowering patients with their healthcare data and making it as easy as possible for them to participate in the medical research process. We partner with patients and pharmaceutical companies to accelerate precision medicine R&D by securely and efficiently collecting and providing patient samples and relevant health data. We are helping thousands of researchers at 20 of the top 40 global pharmaceutical and biotechnology companies increase the speed and quality at which they are conducting their research. For the past three years, Sanguine received the prestigious designation as a “Great Places to Work” company plus additional awards for leadership and diversity. It is an exciting time; our biotech company is growing quickly and needs the best team members to join us.
About the Role
The VP of Clinical IT will be a key member of the senior management team and provide leadership, vision, and oversight of information systems and technology as it relates to clinical, molecular/lab data, and research operations. A successful executive will maximize the value of Sanguine's patient community and related datasets, through technology and operations. An essential part of this role will support mission-critical applications and technology to support the company's long-term goals which include creating efficiencies in our patient operations, increasing the value of our patient community, and refining our data assets.
A successful candidate will have prior successful experiences implementing new data management technologies and software in regulated pharmaceutical environments, including but not limited to patient data capture, eCOA, e-Consent while driving compliance with associated regulations for E-Consent, CFR Part 11, GDPR, Data Privacy Laws, GCP requirements. They will also have demonstrated abilities to move quickly and establish efficient and effective plans with tight timelines.
1. Create Efficiencies in Patient Recruitment/Operations, Field Operations, Lab Operations
- Implement fit for purpose technology solutions to maximize operational efficiency across Patient Recruitment/Operations, Field Operations, Lab Operations through a partnership with each functional unit leader
- Drive adoption of newly implemented technologies (e.g. CTMS platform, EDC, LIMS)
- Standardize Data and Data Collection
- Implement clinical data repository; standardize existing dataset and transfer from current system (Salesforce.com)
- Establish integration operations with EDCs, EMRs, etc. to reduce manual data entry, data errors and reconciliation, maintain data integrity and compliance.
- Develop plan to manage Medical Data Record coordination function.
- Identify areas to maximize value of Sanguine's Patient Community (e.g. PRO data)
- Maximize value of patient community and database by adopting and integrating new clinical technology capabilities
- Responsible for orchestrating the review and company practices associated with clinical systems validation (CSV) requirements
- Ensure Regulatory Compliance & Quality
2. Responsible for orchestrating the review and company practices associated with clinical systems validation (CSV) requirements
- Develop team structure, supervise current team and/or contractors for CSV/IT contractor, hire and manage additional resources.
- Stay abreast of the latest developments, advances and trends in healthcare and information technology, and federal and state legislation to ensure optimal professional effectiveness and competence.
- Responsible budgets, systems and resources in excess of 1M
- Advanced Degree in Computer Science, Business Information Systems
- 15 years experience with pharmaceutical drug development processes and clinical systems, including CTMS, IRT, EDC, Clinical Data Repositories (CDR) and/or other related technology in pharmaceutical/biotechnology industry
- 3 or more years of experience in Quality Assurance or IT Systems Validation testing
- 5+ years managing or leading IT Teams; Personal accountability when it comes to both decision-making and supervising teams
- Expertise in Project Management processes, strategies and methods
- Abilities to document process, workflow and source for appropriate technologies to support
- Must be able to maintain a professional working environment, free from background distractions and noise.
- PMP Certification
- Experience with GDPR, e-Privacy Directives, e-Consent, eCOA and ePRO, BAA, HIPAA & Privacy Rules
- Certified Clinical Data Manager - Society for Clinical Data Management (SCDM)
- Excellent communication skills both oral and written
- Ability to simplify the complex into actionable steps and establish logical timelines
- Critical thinking skills to connect all the associated systems and people actions
- Training to aid in system adoption and successful implementation with all user level
- Technology Experiences
- CTMS, CDR, eTMF, Advanced Data and Analytics tech, Clinical Data Repository
- GDPR, e-Privacy Directives, e-Consent, eCOA and ePRO, BAA, HIPAA & Privacy Rules
- Google Suite/MSFT Suite
Sanguine is an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.