Medidata Rave Programmer Jobs (NOW HIRING)

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

The Senior Associate, Clinical Programming (EDC) will be responsible for overseeing all aspects of database build support for Kite's clinical development programs with guidance from the Data Management Staff. This position will be responsible for building clinical databases, performing migrations, and assisting with the technical aspects of clinical databases necessary for clinical data collection, and data review. This role will be the representative to provide guidance and technical solutions for studies as well as participate in technical initiatives.

Responsibilities (including but are not limited to):

• 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

• 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 compliance to Kite standards

• Ensure consistency and adherence to standards and governance across studies

• Support Data Review activities (e.g., Review Data Review Plan)

• Develop, assess, and monitor project priorities/timelines for programming deliverables

• Participate in study team meetings and provide technical expertise with database applications 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 in 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 can 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 3+ years of experience in Clinical Programming OR

• BS/BA in life science or related discipline and 5+ years of experience in Clinical Programming OR

• Associate's degree and 7+ years of experience in Clinical Programming OR

• High School degree and 9+ years of experience in Clinical Programming

Preferred Qualifications

• 3+ years of experience with Medidata RAVE including database build, edit check programming, data extraction, migrations

• 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

• Understanding of data standards (CDISC, CDASH) in the clinical trial environment

• 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: $123,930.00 - $160,380.00. 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:

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.

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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

For 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 disability,genetic 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 laws. In 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 contactApplicantAccommodations@gilead.com for assistance.

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

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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.