Manager, Clinical Programming (EDC)

Join Kite : Advancing Cancer Therapies

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) :

• Supervising and training clinical programmers in the performance of their duties
• Management of programming deliverables in coordination with internal and external cross functional teams
• Execution of programming activities for multiple studies of increased complexity and across indications / therapeutic areas
• Input into the SOW activities for vendors
• Development and maintenance of eCRF and EDC database, integrations and module connections based on the protocol and Kite standards
• Oversee creation of operational metadata ensuring compliant to Kite standards
• 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
• 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
• 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

The salary range for this position is : $133,195.00 - $172,370.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.

Basic Qualifications

Preferred Qualifications