Clinical Data Management Manager

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

At Gilead/Kite our pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to

confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

As a Manager Clinical Data Management (CDM) at Gilead you will ...

You will be a hands-on role working cross functionally with internal and external partners to support our efforts in this fast-growing and important area of cell therapy. The role will report to the Senior Manager CDM or higher.

The Manager CDM will be responsible for leading and overseeing all aspects of clinical data management for Kites clinical development programs with guidance from the Senior Manager CDM or Associate Director CDM. The Manager CDM will be the lead representative working with cross-functional teams such as Clinical Operations Safety Biometrics Clinical Development and Regulatory as necessary.

This position will be responsible for managing other data management roles overseeing CDM vendors (external and/or CRO) creating and maintaining project timelines and data management documents working with Clinical Programming to create clinical databases and data quality reports leading clinical data collection and data review activities and study closure.

Key Responsibilities :

• Lead the management of CDM deliverables in coordination with internal and external cross-functional teams

• Lead by providing CDM expertise for data coordination collection and cleaning to efficiently ensure high quality data

• Perform the execution of end-to-end Data Management activities (e.g. eCRF development Data Review study lock) for multiple studies across therapeutic areas and/or indications

• Develop and manage data management timelines to ensure study goals and activities are met

• Oversee External Data Management activities by providing project level support of External Data Management tasks (development of Data Transfer Plans coordination of file transfers to meet study deliverables etc.)

• Anticipate obstacles and difficulties of stakeholders and staff and acts upon them or escalates accordingly in order to meet team goals

• Manage the development and finalization of CDM documents to be filed in the eTMF

• Review and manage the eTMF for completeness and accuracy ensuring inspection readiness

• Serve as a primary point of contact for internal and external study team members in relation to all Data Management activities

• Ensure completeness accuracy and consistency of clinical data and data structure across all projects on an ongoing basis

• Responsible for data review query management and metric report delivery to study teams

• Coordinate study timelines and database snapshots for analysis and safety review meetings

• Participate in and/or represent CDM during internal audits as well as Health Authority audits and inspections

• Participate in the development review and implementation of processes policies SOPs and associated documents affecting CDM

• Participate in CDM and cross-functional initiatives

• Proactively provides input to continuous improvement activities within Clinical Data Management and provides the relevant support for implementation

• Flexible to changing priorities detail-oriented works well under pressure and able to take on unfamiliar tasks

• Demonstrates an ability to prioritize and delegate effectively

• Demonstrates ability to assume expanded scope of responsibility with respect to volume and complexity of clinical project work

• Works collaboratively with Clinical and Statistical Programming Clinical Operations Biostatistics and others study team members to meet project deliverables and timelines

• Demonstrates proficiency with web-based Electronic Data Capture (such as Medidata Rave and other clinical data management systems)

• Experienced with industry wide thesauri/dictionaries such as MedDRA and WHODD

• Demonstrates excellent verbal and written communication skills including the ability to clearly describe critical technical CDM aspects to non-CDM staff

• Training and mentoring of junior CDM staff

• Communication and escalation of project level issues including processes timelines resourcing performance etc.

• May have direct report responsibilities including oversight and development

Basic Qualifications

• MS/MA in life sciences or related discipline and 4 years of experience in Data Management
  OR

• BS/BA in life science or related discipline and 6 years of experience in Data Management

Preferred Qualifications

• Experience as independent lead in managing clinical data management deliverables for regulatory filings

• At least 6 years of relevant industry experience with clinical trials and a successful track record of leading through influence working across complex global organizational matrices

• Experience in Industry Standards Guidelines (e.g. CDISC) in either the collection (CDASH) tabulation (SDTM) or analysis (ADaM) models

• Strong knowledge of industry-leading EDC tools (e.g. Medidata Rave Veeva EDC Medrio EDC Oracle TrialGrid etc.) and well versed in industry trends and emerging technologies supporting data collection

People Leader Accountabilities:

Create Inclusion - knowing the business value of diverse teams modeling inclusion and embedding the value of diversity in the

way they manage their teams.

Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current

performance and future potential. They ensure employees are receiving the feedback and insight needed to grow develop and

realize their purpose.

Empower Teams - connect the team to the organization by aligning goals purpose and organizational objectives and holding

them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

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 theKnow 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.