Sr. Clinical Trials Management Associate

Kite Pharma, Inc. California , MD 20619

Posted 3 months ago

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

The Senior Clinical Trials Management Associate is a primarily an in-house sponsor position (although some travel is required) who will oversee multiple aspects of clinical trial conduct including study start-up, document generation and review, tracking of samples, enrollment of study participants, as well as scheduling of treatment with investigational product. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to the Clinical Trials Manager or Senior Clinical Trials Manager of Clinical Operations.

NOTE: This position can be located onsite in Santa Monica, CA, Foster City, CA, or Seattle, WA.

Responsibilities include but, are not limited to:

  • Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manger (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).

  • Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met. Provides corrective instruction, as necessary, when performance expectations are not being met.

  • Attends internal team and other meetings as required.

  • Provides training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences.

  • Creates and reviews site feasibility assessments required for study participation.

  • Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations.

  • Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager.

  • Prepares metrics and updates to key deliverables for management.

  • Assists in the resolution of clinical trial queries for interim analysis, primary analysis and final database locks.

  • Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team

  • Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.

  • Participates in the development, review and implementation of departmental SOPs and processes.

  • Other duties as assigned.

Requirements:

  • Bachelor's degree in nursing, science or health related field required with at least five years of related experience. At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus

  • Must be willing to travel at least 25% (possibly more)

  • Ability to manage time demands, incomplete information or unexpected events

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:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.

Gilead 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 log onto your Internal Career Site to apply for this job.


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