Intercept Pharmaceuticals Manager, Clinical Data Management in San Diego, California
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 potent first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name “Ocaliva,” is approved in the U.S., EU and Canada for use in primary biliary cholangitis (PBC), a rare autoimmune liver disease. OCA is also being investigated as a treatment for nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to NASH. REGENERATE is the first and largest Phase 3 study in NASH – a chronic disease that threatens the lives of millions of people in the U.S. alone. By 2020, NASH is expected to overtake hepatitis C as the leading cause of liver transplants in the U.S. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.
Based on the positive results from REGENERATE, Intercept intends to file for regulatory approval in the U.S. and EU in the second half of this year. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH. As part of this effort, Intercept is beginning to build a new commercial organization, and this opportunity in Talent Acquisition will play a pivotal role in preparing the company for the successful launch of OCA’s second indication.
The Manager, Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This position has a leadership role to proactively develop plans for the utilization of EDC system processes and other clinical data applications that allow for internal control of clinical databases. This position may have direct supervisory responsibilities for internal staff or external consultants. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC Documentation.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
Assist in the development and implementation of strategic vision for data management (DM) group
Work closely with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to develop CRF's to ensure the required information is captured for statistical analysis. Work with biostatistician and SAS programmers to compile and maintain SAS data dictionary.
Perform coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding with the clinical study manager
Responsible for data management activities, database cleaning and lock activities including developing data management plans, supervising database development and reviewing and processing clinical trial data to ensure completeness, accuracy and consistency of clinical trials databases.
Prepare and distribute or facilitate distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.
Participate in cross functional team meetings as requested and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.
Lead interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data.
Develop and update SOP's associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.
Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
Mentor clinical team members by resolving problem and providing DM guidance.
Manage multiple and varied tasks, prioritize workload with attention to detail.
Other duties as assigned.
Lead the completion of data management activities to meet project timelines and communicate status to respective team members.
Contribute to development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.
Requires a Bachelor’s degree in a related field.
Minimum of 7 years’ experience in a clinical research data handling environment with relevant practical pharmaceutical/biotechnology experience in protocol review/CRF design, EDC clinical study databases and data management.
Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (PRO) and other database technologies.
Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages.
Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.
MedDRA and WHO Drug coding proficiency is preferred.
Knowledge of SAS is desired.
Excellent time management, flexibility, ability to coordinate workload and meet established deadlines.
REQUIRED KNOWLEDGE AND ABILITIES:
Strong verbal and written communication skills are essential.
Excellent organization and multi-tasking skills.
Exceptional interpersonal skills and problem solving capabilities.
Proven meeting planning skills.
Ability to work effectively across a matrix organization.
Ability to work independently and prioritize with minimal daily instruction.
Ability to think strategically in order to improve current processes.
Keyword: Manager, Data Management
From: Intercept Pharmaceuticals