Principal Clinical Data Manager

Company : Katalyst Healthcares & Life Sciences

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.
• Assist with responding to questions and findings from QA audits; ensure responses to Corrective Action Forms (CAFs) are closed out appropriately.
• Actively 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.
• Assist 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.
• Actively 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 noted above. OR
• PhD in computer science or a related discipline and 4+ years of similar experience noted above 3+ years of experience serving in a supervisory or lead capacity.
• 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.

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