Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com
Job Responsibilities

• Assume ownership for assigned studies and project deliverables.
• Coordinate and manage Data Management activities, timelines and deliverables from study start to study close out with internal and external stakeholders.
• Oversee CRO and vendors, and participate in study start-up activities, including development, review, and approval of eCRF requirements, EDC database specifications, Data Transfer Specifications, eCRF completion guidelines, Data Management Plans, Data Validation specifications and User Acceptance Testing.
• Accountable for ensuring all data quality and timelines for Data Management are met and aligned with study milestones and business goals.
• Strong cross-function understanding on the impact of Data Management processes to other stakeholders.
• Responsible for ensuring data collected meets the requirements of the study objective and quality standards for proper analysis.
• Request and/or create and review project specific reports (data review listings, metrics, KRIs etc).
• Manage data query process for inconsistencies, omissions or errors.

Requirements

• Bachelor’s degree or higher
• Experience in Data Management for Pharmaceutical/ Biotech/ CRO
• Oncology experience highly desirable
• Proven track record of on-time and high-quality Data Management deliverables
• Practical knowledge of ICH, FDA, GCP and GDPR regulations and guidelines
• Demonstration of excellent communication skills in writing and in interactions with colleagues
• Highly organized, outcome oriented, self-motivated performance
• Ability to adapt to change in a growth environment
• Ability to effectively manage a variety of Data Management tasks for multiple clinical studies at different stages of activity
• Experience with Medidata RAVE is desired
• Familiarity with handling lab, images, biomarker data from external data sources
• General knowledge of industry standards and best practices such as CDISC, CDASH, SDTM
• Knowledge of and experience with MedDRA and WHO Drug data dictionaries
• Skill and knowledge in ad hoc data reporting, data review listings and metrics reporting