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Apogee Therapeutics · 2 hours ago

Clinical Trial Manager

United States

Full-time

Remote

Senior Level

$145K/yr - $160K/yr

5+ years exp

Apogee Therapeutics is a biotechnology company focused on developing biologics for inflammatory and immunology conditions. They are seeking a Clinical Trial Manager to oversee global clinical trial programs, ensuring adherence to regulatory guidelines and managing relationships with CROs and vendors to meet project objectives.

BiotechnologyLife ScienceMedicalTherapeutics

Responsibilities

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

Qualification

Clinical trial managementGCP complianceVendor managementPatient enrollment strategiesDrug development processICH guidelinesCross-functional collaborationCommunication skillsProblem-solving skillsTime management skills

Required

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

Benefits

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