Manager, Clinical Programming (EDC)

Kite Pharma • Santa Monica, CA

4d

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description Responsibilities (include but are not limited to): 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

Nice To Haves

• 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

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

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager