Clinical Trial Manager Job at Apogee Therapeutics

Job Description

We are seeking a Clinical Trial Manger (CTM) to join our growing Clinical Operations team! In this newly created role, you will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). You will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus is partnership with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines, and that the quality of data is suitable for regulatory submission/inspections. You will have visibility and regular interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries.

Job Responsibility

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

What we offer

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

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Clinical Trial Manager

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