Hybrid Manager, Clinical Programming – EDC

at Gilead Sciences

• Job title: Manager, Clinical Programming – EDC
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $133,195 - $172,370 per year
• Degree requirement: No Education Requirement
• Tech skills: Tableau
• Location requirements: Hybrid, Santa Monica, United States

About the role

• Manager of Clinical Programming at Kite overseeing complex programming deliverables and supervising clinical programmers. Working on pivotal cancer therapies and ensuring adherence to best practices and standards.

Responsibilities

• 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