May have direct responsibility for supervising and training clinical programmers in the performance of their duties
Management of programming deliverables in coordination with internal and external cross functional teams
Perform the execution of programming activities (eCRF and EDC database, integrations, and module connections) for multiple studies of increased complexity and across indications/therapeutic areas
Provide input into the SOW activities for vendors
Perform the development and maintenance (migration) of eCRF and EDC database, integrations (e.g., IxRS) and module connections (e.g., Safety Gateway Configuration) based on the protocol and Kite standards
Oversee creation of operational metadata (including CRF and external) ensuring compliant to Kite standards
Provide oversight for programming activities which are outsourced to a CRO/Vendor
Ensure across studies consistency and adherence to standards and governance
Support Data Review activities (e.g., Review Data Review Plan, develop reporting tool reports, validate reports)
Perform support of snapshot, database lock activities and deliverables restriction
Develop, assess, and monitor project priorities/timelines for programming deliverables
Participate in study team meetings and provide technical expertise with database and reporting applications (e.g., EDC, Tableau, J-Review, Business Objects) and support as needed
Routinely interface with cross-functional team members
Ensure that SOPs are properly followed, and documentation is available
Align with EDC vendor regarding system updates, EDC platform integrations, and issue resolution
Ensure following programming best practices
Resolve problems as they arise within defined procedures and escalate, if necessary, at appropriate time
Represent as internal team leader who decides best course of action
Participate in CDM, Programming and cross-functional initiatives
Participate for programming activities during internal audits as well as Health Authority audits
Align with the department and company strategy and model
Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
Prioritize and delegate, if applicable, effectively study and initiative responsibilities
Prepare for expanded scope of responsibility with respect to volume and complexity of clinical project work as well as direct report responsibility
Work collaboratively with Programming (Clinical and Statistical) Clinical Operations, Biostatistics and others study team members to meet project deliverables and timelines.
Build networks to achieve influence with other functions and represent as Programming technical expert
Participate in department and/or cross-functional process improvement initiatives as well as special projects and create efficiencies within programming processes
Participate in review, approve and train on department procedures including SOPs and Working Practices
Actively Participate in programming team meetings when appropriate.

Requirements

MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Programming OR BS/BA in life science or related discipline and 6+ years of experience in Clinical Programming
Technical experience in clinical development
Good understanding of regulatory, industry, and technology standards and requirements
Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management
Experience with Medidata RAVE including database build, edit check programming, data extraction, migrations
Understanding of data standards (CDISC, CDASH) in the clinical trial environment
Experience with SAS programming (recommended)
Experience with Spotfire and/or J-Review programming (recommended)
Excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
Demonstrate ability to work in a team environment with clinical team members
Good planning and project management skills as well as vendor management
Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks.

Benefits

Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical programmingeCRFEDC databasedata integrationdatabase migrationSAS programmingMedidata RAVECDISCCDASHdata management

Soft Skills

communication skillsteam collaborationproject managementflexibilitydetail-orientedproblem-solvingleadershipplanningvendor managementability to work under pressure