About the Role:Leads, performs, and oversees data management activities for assigned clinical studies for both in-house and outsourced clinical trial data; evaluates, develops, and implements data management processes, procedures, and tools to ensure business requirements are met; collaborates within Biometrics and with Medical, DSPV, Regulatory, QC, and other internal customers to ensure high quality data in support of regulatory submissions, safety reporting, and publications.
Your Contributions (include, but are not limited to):- Leads, performs, and oversees data management activities for clinical studies and/or clinical programs
- Experience leading and supporting First-In-Human (FIH) clinical studies, including early protocol review, eCRF and database design, and alignment with dose-escalation and safety objectives
- Hands-on management of data management activities for FIH studies, with emphasis on rapid data cleaning, near real-time safety data review, and support for frequent interim analyses
- Close collaboration with Clinical Operations, Safety, and Biostatistics teams to support timely decision-making and governance in FIH studies
- 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 in-house/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 OR
- 3+ years of experience serving in a supervisory or lead capacity
- Qualified candidate must have a thorough understanding of the drug development process
- Experience working with GCP and CDISC/CDASH/SDTM standards
- Developing SOPs/Work Instructions, and following required FDA guidance documents
- Must have hands-on clinical database programming skills, including SAS, SQL, and Medidata Rave Architect
- Experience with Business Objects, Rave Targeted SDV and Batch Uploader preferred.
- Experience with C# programming (custom functions) is a plus
- Ability to communicate effectively both verbally and in writing
- 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
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The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
