Sr. CTM Associate - Oncology, Hematology or Cell Therapy

Sr. CTM Associate – Oncology, Hematology or Cell Therapy

Location:

United States – California – Santa Monica

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.

The Senior Clinical Trials Management Associate is a primarily an in‑house sponsor position (though some travel is required) who will oversee multiple aspects of clinical trial conduct including study start‑up, document generation and review, tracking of sample enrollment of study participants, and management of vendors. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.

The position will report to a Senior Clinical Trials Manager of Clinical Operations.

• 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 manager (e.g., Clinical protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures 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 and data review for interim analysis, primary analysis and final database locks.
• Prepares site newsletters and other correspondence related to clinical trial conduct (e.g., 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.
• May lead less complex studies and/or manage components of more complex studies as a member of the study team.
• May participate in department initiatives or special projects, such as developing new tools or processes.
• Ability to coach less experienced colleagues in solving problems.
• Understands how decisions have an impact to the broader study goals.
• Other duties as assigned.

• BS/BA and 4+ years of related experience – OR –
• MS/MA and 2+ years of related experience

• At least three years of clinical trial experience with oncology, hematology, cell therapy or related therapeutic area experience considered a plus.
• Multiple years of experience managing the work of external candidates.
• Must be willing to travel at least 25% (possibly more).
• Ability to manage time demands, incomplete information or unexpected events.
• Must display…