Data Manager

RESPONSIBILITIES:
• Provide leadership, training, and support to Clinical Data Managers
• Responsible for data management and back-end activities supporting KPTI clinical programs from
DM strategy, database start-up through database lock and CSR/submission.
• Oversee data management vendors with respect to key performance indicators, metrics, and
program level deliverables and timelines
• Oversee building, validation, and maintenance of clinical trial databases in accordance with
ICH/GCP guidelines and current regulatory requirements
• Oversee adherence to eCRF standards (CDASH) and data capture conventions and CDISC compliant
output for statistical analysis
• Oversee key documents such as data validation specifications and programs, manual data review
guidelines, computerized edit check programs, Data Management Plans (DMP), etc.
• Work closely with other functional areas to ensure high quality data output including data
cleaning/validation, SAS listings review, TLF dry runs, etc.
• Develop, track, analyze, and report on internal data management performance metrics
• Oversee and Develop data transfer agreements and specifications with various vendors
• Liaise with external vendors (Central Labs) in support of timelines and data related deliverables;
will also liaise with clinical monitoring in the data management function
• Perform all aspects of Data Management as related to processing and QC of the data, monitor
study status, (e.g. Enrollment, eCRFs, Query Aging, etc.) and provide status reports to the team and
department throughout the study
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based
on metrics data, audit reports and input from project team members.
• Review and approve study timelines
• Monitor timelines and ensure that clinical data management timeline are met with quality
• Use industry standard conventions, tools, references and process in support of the coding of
Medical History, Adverse Events and Concomitant Medications/Concomitant Procedures
• Ensures all DM procedures are executed with a high attention to detail, accuracy and timelines
• Review and provide feedback on Protocols, Statistical Analysis Plans and CSRs
• Represent the company DM on project teams, at Face-to-Face Meetings, Conferences, etc.
• Co-create and review DM SOPs and Work Instructions in accordance with current GCP and ICH
guidelines
• Ability to perform all duties of Lead Data Manager at KPTI.
• Ability to travel (~travel time 25%)
• Other duties as assigned
QUALIFICATIONS:
• B.S./B.A. in Science related field
• 7 to 10 years of data management experience in the pharmaceutical or biotechnology industry or
Minimum 5 years data management with 3 years in a supervisory/leadership role.
• Highly organized and detail-oriented with effective planning and strong verbal and written
communication skills
• Strong leadership skills and ability to work within cross-functional teams
• Flexibility and agility to adapt to changing scope of work, able to propose thoughtful solutions to
challenges and issues, proactively implement solutions, and communicate effectively with
colleagues
• Experience/knowledge of GCP and ICH guidelines