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Senior Clinical Data Manager

Job Description

COMPANY SUMMARY:

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. OCA, marketed under the brand name \"Ocaliva ® ,\" is approved in the U.S., EU and Canada for certain patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first product to be approved for PBC in over twenty years and our team is proud to have been pioneers in providing the first second-line treatment option to patients with such critical need. The Ocaliva ® launch in 2016 also marked Intercept's successful transition from a development-stage company to a fully integrated commercial organization with continued growth.

In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (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. 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 submitted the first new drug application for a NASH treatment to the U.S. FDA in September 2019. 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 Clinical Data Management will play a pivotal role in preparing the company for the successful anticipated launch of OCA's second indication.

POSITION SUMMARY:

The Senior Clinical Data Manager coordinates and completes data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting.

CORE ACCOUNTABILITIES:

The successful candidate must be able to perform each of the following satisfactorily:

  • Coordinate and complete data management activities to meet project timelines and communicate status to respective team members.
  • 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.
  • 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.
  • 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.
  • Oversee interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data.
  • Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
  • 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

QUALIFICATIONS:

  • Requires a Bachelor's degree in a related field with a minimum of 3 years' experience working 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 vendor management experience using Medidata Rave and RTSM is preferred.
  • 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.
  • 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.
  • 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
  • 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
  • Understanding the legal and compliance environment
  • Ability to have fun!



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Senior Clinical Data Manager

San Diego, CA
Full Time

Published on 07/01/2020