Intercept Pharmaceuticals Director, Clinical Data Management in San Diego, California

Job Descriptions:

POSITION SUMMARY:

The Director, Clinical Data Management, is responsible for leading the data management functions and coordinating functions related to the planning, execution, collection, and cleaning of clinical data. This position has oversight of activities leading to the final delivery of clean clinical data for the purpose of clinical study reports, publications, and regulatory submissions. In addition, this position has leadership role responsibilities to proactively develop plans for the utilization of EDC system 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 take a leadership role in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC documentation.

ESSENTIAL FUNCTIONS:

To perform this job successfully an individual must be able to perform each essential function satisfactorily.

  • Develop and implement strategic vision for data management (DM) group

  • Responsible for managing, planning and coordinating the activities of the Data Management group

  • Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.

  • Ensure that the Data Management group is aligned with business objectives and complies with FDA requirements.

  • Contribute to development of outsourcing strategies and relationships with outsourcing partner and play a key role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.

  • Manage the clinical data managers within the organization.

  • Work closely with CROs to prepare and ensure proper execution of data management plans; manage data management projects from beginning to end.

  • Work closely with Medical Directors, Medical Monitors, CTAs, and CRAs in planning and execution of DM activities regarding clinical studies.

  • Coordinate with biostatisticians, data managers, CRAs, programmers, etc., to expedite and assure the flow of data between study sites, the data management group.

  • 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.

  • Coordinate with SAS programmers to create and validate database design and edit check specifications.

  • Communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.

  • Ensure coding of safety data is accurate using industry standard coding conventions.

  • Coordinate the transfer of clinical data between all vendors participating in a clinical study.

  • Oversee interactions with central 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.

  • Assist with the validation of the statistical output for final reports.

  • Audit potential data management vendors, as appropriate.

  • Assist in design of case report forms (CRFs), DMPs, and CCGs for clinical studies.

  • Provide oversight on quality database design, validation, and deployment to ensure quality and efficiencies through data and process standardization.

  • Take a leadership role in the review and query of clinical data. This includes the critical review of data-populated tables, figures, and listings as part of the database clean-up and prior to database lock.

  • 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.

  • 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.

Required Experience:

QUALIFICATIONS:

  • Requires a Bachelor’s degree.

  • Minimum of 8 years’ experience in a clinical research data handling environment with relevant practical experience in protocol review/CRF design, clinical study databases and data management and at least 2 years’ experience managing others.

  • Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.

  • Experience with SAS.

  • Excellent time management, 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: Director, Clinical Data Management

From: Intercept Pharmaceuticals