At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist marketed under the brand name \"Ocaliva ® \" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.
Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2021.
People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.
At Intercept, we foster an environment that celebrates creativity, collaboration and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.
As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking an Associate Director, Clinical Data Systems.
The Associate Director, Clinical Data Systems, is responsible for leading and managing the EDC platform within data management, and coordinating functions related to the planning, execution, and collection of clinical data as it relates to the software. This position serves as an interface between Clinical Data Management, IT, Clinical Programming, QA, and other functional groups as needed, and has oversight of activities leading to data analytics, EDC reports and workflows, cloud administration, safety data, and other aspects of providing tools for the study teams to process and consume clinical data. This position may have direct supervisory responsibilities for internal staff or external consultants. This position will take a leadership role in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC documentation.
The successful candidate must be able to perform each of the following satisfactorily:
- Primary point of contact with the EDC vendor(s) to manage the contract and services provided
- Assist in the development and implement technological solutions to support the strategic vision for the data management (DM) group and other departments within Clinical Research and Development.
- Liaise and provide oversight to the EDC vendor's Help Desk Support Management team by reviewing tickets and resolutions on an ongoing basis.
- Facilitate discussions among Clinical Data Management, IT, Clinical Operations, Clinical Programming, QA, and EDC Programming to ensure appropriate methods are used for reporting (i.e. SAS, BO4, J-Review, etc.), metrics and analytics.
- Manage the technical support for the core configuration of the company's Electronic Data Capture URL. Responsible for the company's URL study and user administration and security within Cloud Administration. Serve as a member on DM initiatives and other technical project teams.
- Manage system integration activities, application updates, and change control documentation.
- Contribute to development of outsourcing strategies and relationships for EDC system/technical activities with outsourcing partners and play a key role in the identification of quality DM partners including coordinating the review and approval of any Master Services Agreement.
- Provide CRO oversight for system related activities including such things as user access and account management and development of study reports and metrics. Serve as escalation point for these types of issues and provide guidance in issue resolutions.
- Manage clinical EDC Developers or others performing EDC system support activities within the organization.
- Coordinate with biostatisticians, data managers, CRAs, programmers, etc., to expedite and assure the flow of data between study sites and the data management group.
- Develop, prepare, and distribute or facilitate distribution of study metrics including such things as periodic reports of study status, CRF completion status, missing pages, query aging, etc.
- Participate in cross functional team meetings as requested with an emphasis on supporting EDC study build activities requiring review of scripts, custom functions, custom reports, and related activities.
- Communicate with all departments regarding project technical/system statuses/issues and provide ongoing feedback about data management and CRA workflows to increase efficiency.
- Assist the study data managers to establish data transfer processes for all clinical vendors participating in a clinical study.
- Develop and update SOP's associated with using Medidata's Rave modules (EDC, RTSM, Coder, Safety Gateway, CTMS) on Intercept's URL and change control documentation to fulfill GAMP5 requirements.
- Review Release Notes and discuss with Lead Data Managers to assess impact on Intercept's studies
- Work with QA (Computer System Validation QA) to develop appropriate processes for managing Rave studies including such things as UAT Plans, Test Migration activities, custom script review and testing and related documentation; assist with training data managers on these processes.
- Assist with developing guidance documents for custom reports generated using Rave or related tools; when appropriate, QC content of these custom reports.
- Assess potential data management vendors from a system administration perspective, as appropriate.
- Provide oversight on quality database design, validation, and deployment to ensure quality and efficiencies through data and process standardization.
- Provide technical direction to facilitate the adoption and use of technologies for DM and trial management.
- Assure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines related to technical systems used at Intercept.
- Mentor clinical team members by resolving problems and providing guidance on clinical applications supporting the clinical studies.
- Manage multiple and varied tasks, prioritize workload with attention to detail.
- Other duties as assigned.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
- Drive the spirit of \"ONE Team\" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
- Make Intercept a truly desired place to work
Experience and Skills
- Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, or related field (such as healthcare) required.
- Minimum of 8 years of experience in a clinical research data handling environment with relevant practical experience in protocol review/CRF design, clinical study databases and data management. 2 years of experience managing others preferred.
REQUIRED KNOWLEDGE AND ABILITIES:
- Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.)
- Strong understanding and application of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferred
- Strong decision-making, influencing, negotiation, and project management skills.
- Technical skills and experience using Medidata Rave and data visualization tools (e.g., Spotfire, J-Review)
- Experience with Rave Cloud Administration preferred
- Experience with BO4 preferred
- Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills preferred.
- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
- Strong verbal and written communications skills
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Ability to have fun and thrive in a growing, diverse and inclusive work environment