Clinical Trial Manager - Onsite

Overview

Who we are.

Dendreon is making the battle against cancer personal. Our flagship product PROVENGE® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.

If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Core Values:

• Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer
• Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
• Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
• Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win together when everyone performs.

Your Role: (Onsite 5 days a week)

The Clinical Trial Manager (CTM) will assist with overseeing operational aspects of clinical research trials, including vendor oversight, monitoring at select sites, and other logistical operations as required. 

The CTM will work closely with the Director of Clinical Operations and other cross-functional representatives within Dendreon, and designated CROs and vendors to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. This individual will report into the Director of Clinical Operations.

Responsibilities

Your Work:

• Responsible for with assigned aspects of clinical trials to ensure on time completion, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines and study specific manuals and procedures
• Assist with identification and hiring of appropriate CROs and third-party study vendors
• Responsible for overseeing performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Director or CRO as appropriate.
• Develop and maintain clinical trial timelines, identifying critical paths and potential risks.
• Oversee site selection, initiation, monitoring, and closeout activities
• Track and report on progress of study including site activation, patient enrollment, monitoring visits and site performance.
• Assist with CRA and third-party vendor with site interactions, protocol and site training and site monitoring as needed.
• Maintain Trial Master File (TMF) compliance and oversee quality control processes.
• Performs clinical data review of data listings and summary tables, including query generation as needed.
• Develops departmental SOPs, project-specific processes, and protocol-specific reference materials.
• Collaborate with cross-functional teams including Clinical Immunology, Data Management, Biostatistics, Medical Affairs, Patient Operations and Regulatory.
• Represent department in cross functional teams, projects and related problem resolution.
• Prepare and present study updates to senior management.
• Perform other responsibilities as assigned.

Scope:

• Uses professional concepts to contribute to development of company's concepts and principles and to achieve objectives in creative and effective ways.
• Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for    obtaining results.
• Acts independently to determine methods and procedures on new assignments.

Qualifications

Required Experience & Education :

• Bachelor’s degree or equivalent
• 5 years clinical operations experience in the pharmaceutical industry with knowledge of GCP/ICH guidelines and the clinical development process
• Proven track record of successfully managing multiple clinical trials
• Experience managing vendors, including performance assessments and finances (invoice review, change order management, budget reforecasting, etc.).
• Experience with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Strong interpersonal, communication (written and verbal), and organizational skills.
• Background in immuno-oncology or targeted therapy studies.
• Demonstrated understanding of oncology endpoints, RECIST criteria, and oncology-specific safety monitoring.
• Demonstrated ability to work independently as well as part of a multi-functional study team
• Ability to prioritize and handle multiple tasks and projects simultaneously in a fast-paced environment.
• Able to solve problems under pressure
• Must be willing to travel domestically as needed

Working Conditions and Physical Requirements:

• Office based position
• Ability to sit or stand for extended periods of time. 
• Finger dexterity sufficient to use a computer and to complete paperwork activities.
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
• Ability to work across multiple time zones when necessary
• Hearing sufficient to communicate with individuals by telephone and in person. Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.