Principal Clinical Data Manager

Principal Clinical Data Manager

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• 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
• Participates in, reviews, and leads development of policies, Standard Operating Procedures (SOPs), processes, and associated documents for data management; provides input on SOPs and processes in which data management is involved
• Promotes/advocates data management at inter‑ and intradepartmental meetings
• Provides technical expertise to staff within Data Management, Biometrics, and other NBI departments; develops and executes training, including project‑specific training, as necessary
• Assists with responding to questions and findings from QA audits; ensures responses to Corrective Action Forms (CAFs) are closed out appropriately
• Actively researches current industry trends and shares information with appropriate individuals at NBI
• Recommends improvements to existing data management practices and procedures, including identifying, recommending, and implementing solutions for technology issues
• Assists in the development of standardized documents within data management (both within and across projects/programs), including electronic case report forms and edit checks
• Oversees screening, selection, validation, and implementation of data management software purchases and upgrades
• Participates in selecting outsourcing vendors and reviews data management sections of proposals, including scope of work; monitors budgets as appropriate
• Coordinates data management timelines for individual projects and for clinical programs, including database lock, DSMB meetings, data review meetings, and monitors CRO performance of data management tasks to ensure that timelines are met and that any resource issues are identified and resolved
• Monitors in‑house resources of assigned projects and identifies potential deficiencies; works with supervisor to develop and implement a plan to overcome any obstacles
• Ensures that appropriate quality control checks and audit procedures are implemented according to department SOPs
• Runs data review listings, issues queries, codes Medical History and AE data using MedDRA dictionary and codes concomitant medications using WHO Drug dictionary
• Collaborates with database programmer to ensure NBI database standards, including CDISC/SDTM, are followed for both in‑house and, if appropriate, outsourced projects
• Identifies areas of risk and proactively communicates issues and solutions to supervisor and/or appropriate colleagues and team members
• Actively participates in data management‑related NDA submission activities, as appropriate
• Provides feedback, as requested, for performance evaluations. Identifies strengths and areas for improvement for DM team members and works with supervisor to create a plan to develop team members
• Performs other duties as assigned

• 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
• Ability 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
• Ability 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

Seniority level:
Mid-Senior level

Employment type:

Contract

Job function:
Information Technology

Industries:
Pharmaceutical Manufacturing