Clinical Trial Manager

Role Overview

• Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project objectives are met
• Initiate and build strong relationships with key opinion leaders and clinical site staff
• Partner with the CRO to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget for assigned regions
• Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data
• Proactively identify and manage study related risks
• Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs), and consents
• Review and manage study related plans and processes including Investigator agreements (CTA), site budget review, CRFs, CRF guidelines, Statistical Analysis Plans, Pharmacokinetic Analysis Plans, Monitoring plan, Data Management Plan, and Safety Monitoring Plan
• Collaborate with Regulatory/CRO team members to assist with completion/review of regulatory submissions
• Review CRO and vendor contracts/work orders and specifications to align with study objectives
• Review specifications for systems build and participate in User Acceptance Testing (UAT) (eg, IRT, eCOA, EDC)
• Participate in data cleaning and manage database lock activities with cross functional team
• Oversee review and approve essential document packages to enable timely site activations
• Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Participate in TMF review and ensure quality and completeness throughout end of the study
• Ensure the study is always “inspection ready”
• Oversee and coach the functional activities of Clinical Trial Associates allocated to the project

Requirements

• Bachelor’s degree in life science or equivalent
• Minimum of 5 years of clinical trial management experience in conducting international clinical trials in a Sponsor Pharma/Biotech organization. Biotech experience strongly preferred.
• Prior phase II and III experience required
• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Proven proficiency in overseeing complex studies being managed in house and by a CRO
• Demonstrated ability to lead teams and work in a fast-paced, cross functional environment, and able to think critically and creatively
• Experience selecting and managing clinical vendors to support study activities
• Enjoys building relationships with KOLs and site personnel
• Demonstrated ability to build and deliver on patient enrolment strategies
• Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
• Demonstrated ability to review and comprehend complex scientific concepts and clinical data
• Strong planning, time management, and coordination skills
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• Excellent written and oral communication skills
• Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.

Tech Stack

• Google Cloud Platform

Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve