Manager, Clinical Programming (EDC)

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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 effectivelystudy 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

Basic Qualifications:

• 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 OR

Preferred Qualifications:

• 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

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

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