Our mission at Progenity is simple: to help healthcare providers and patients prepare for life. We provide the most advanced molecular technology and the highest levels of service to guide patient care at critical life stages. We continually seek people with the motivation and skills to advance our mission.
The Associate Director, Clinical 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 and paper CRF 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 Progenity processes and procedures for maintaining clinical data and the associated QA/QC Documentation.
RESPONSIBILITIES
- Performs 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.
- Assists in the development and implementation of strategic vision for data management (DM) group.
- Works closely with CROs as needed, to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
- Works 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.
- Works with biostatistician and SAS programmers to compile and maintain SAS data dictionary.
- Performs 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 and Medical Monitor.
- 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.
- Prepares and distributes or facilitates distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.
- Participates 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.
- Leads interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data and data transfer specifications.
- Develops, updates, and implements SOP’s associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.
- Works closely with corporate Quality team.
- Participates in clinical review and validation of statistical outputs used in the preparation of final reports, protocols, and publications.
- Mentors team members by resolving problems and providing DM guidance.
- Manages multiple and varied tasks, prioritize workload with attention to detail.
- Leads the completion of data management activities to meet project timelines and communicate status to respective team members.
- Contributes 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 task orders, and DM components of Master Services Agreements.
This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.
REQUIREMENTS
- Experiences with paper CRF as well as EDC systems.
- Datatrak experience is a plus.
- Bachelor’s degree in a related field required.
- Minimum of 7 years’ experience in a clinical research data handling environment with relevant practical pharmaceutical/biotechnology experience in protocol review/CRF design, EDC (and paper) 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.
- SAS programmer would be a plus.
- Excellent time management, flexibility, ability to coordinate workload and meet established deadlines.