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

The salary range for this position is : $133195.00 - $172370.00. 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

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 :

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections please view the Know Your Rights poster.

NOTICE : EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors :

Please apply via the Internal Career Opportunities portal in Workday.

Required Experience :

Manager

Key Skills

Aviation Safety,Arabic Speaking,Information Technology Sales,JQuery,Db2

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 133195 - 172370