Principal Clinical Data Manager

Katalyst Healthcares and Life Sciences

Santa Clara, CA

Responsibilities:

Leads, performs, and oversees data management activities for clinical studies and/or clinical programs
Performs hands-on clinical data management tasks to support clinical studies, including, but not limited to reviewing study protocols, designing eCRFs, performing and coordinating user acceptance testing (UAT), documenting edit check specifications, QC'ing external data transfers, performing data quality checks/discrepancy review, and ensuring database lock activities are completed
Participate in, review, and lead development of policies, Standard Operating Procedures (SOPs), processes, and associated documents for data management; provide input on SOPs and processes in which data management is involved
Promote/advocate data management at inter- and intradepartmental meetings
Provide technical expertise to staff within Data Management, Biometrics, and other NBI departments; develop and execute training, including project-specific training, as necessary
ssist with responding to questions and findings from QA audits; ensure responses to Corrective Action Forms (CAFs) are closed out appropriately
ctively research current industry trends and share information with appropriate individuals at NBI
Recommend improvements to existing data management practices and procedures, including identifying, recommending, and implementing solutions for technology issues
ssist in the development of standardized documents within data management (both within and across projects/programs), including electronic case report forms and edit checks
Oversee screening, selection, validation, and implementation of data management software purchases and upgrades
Participate in selecting outsourcing vendors and review data management sections of proposals, including scope of work; monitor budgets as appropriate
Coordinate data management timelines for individual projects and well as clinical programs, including database lock, DSMB meetings, data review meetings, and monitoring CRO performance of data management tasks to ensure that timelines are met and that any resource issues are identified and resolved
Monitor in-house resources of assigned projects and identify potential deficiencies; work with supervisor to develop and implement a plan to overcome any obstacles
Ensure that appropriate quality control checks and audit procedures are implemented according to department SOPs
Run data review listings, issue queries, code Medical History and AE data using MedDRA dictionary and code Concomitant Medications using WHO Drug dictionary
Collaborate with database programmer to ensure NBI database standards, including CDISC/SDTM, are followed for both in-house and, if appropriate, outsourced projects
Identify areas of risk and proactively communicate issues and solutions to supervisor and/or appropriate colleagues and team members
ctively participate in data management-related NDA submission activities, as appropriate
Provide feedback, as requested, for performance evaluations. Identify strengths and areas for improvement for DM team members and work with supervisor to create a plan to develop team members
Perform other duties as assigned

Requirements:

BS/BA degree in computer science or a related discipline and 8+ years of experience in the Pharmaceutical Industry, (either inhouse/sponsor or CRO) OR
Master's degree in computer science or a related discipline and 6+ years of similar experience.
Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
Works to improve tools and processes within functional area
bility to work as part of and lead multiple teams
Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
Excellent computer skills
Excellent communication, problem-solving, analytical thinking skills
Sees broader picture, impact on multiple departments/divisions
bility to meet multiple deadlines across a variety of projects/programs, with a high degree of
accuracy and efficiency
Excellent project management skills
Proficiency with Word, Excel, and PowerPoint is required
Thorough understanding of the drug development process
Proficiency with Medidata Rave is required
Knowledge of other programming languages is a plus
Familiarity with Business Objects and SAS is helpful
Strong knowledge of Good Clinical Data Management Practices, CDISC/CDASH/SDTM and other FDA and industry-standard guidelines is required
Demonstrated proficiency in effectively overseeing/managing people (indirectly or directly) and
organizing tasks is necessary

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Vacancy posted 2 days ago

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