Senior Clinical Trials Management Associate

Role Overview

• Oversees multiple aspects of clinical trial conduct including study start-up, document generation and review, tracking of samples enrollment of study participants, and management of vendors
• 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
• 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 (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
• 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

Requirements

• BS/BA in nursing, science or health related field and 4 years of related experience – OR
• MS/MA in nursing, science or health related field and 2 years of related experience
• 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
• Multiple years of experience managing the work of external candidates
• Must be willing to travel at least 25%
• Ability to manage time demands, incomplete information or unexpected events
• Must display strong analytical and problem solving skills
• Attention to detail required
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Working knowledge of transplant patient care and apheresis collection a plus.

Tech Stack

• Google Cloud Platform

Benefits

• Discretionary annual bonus
• Discretionary stock-based long-term incentives (eligibility may vary based on role)
• Paid time off
• Company-sponsored medical, dental, vision, and life insurance plans