Clinical Trial Manager

Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass' scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit www.compasstherapeutics.com.

Our Clinical Operations team is seeking a highly motivated and hands-on Clinical Trial Manager. This position will report to our Director of Clinical Operations. The ideal candidate will have relevant oncology experience, can work independently, and desires to be in an energetic and fast paced environment. This position requires a full-time in office presence as well as up to 15% travel (as appropriate).

Responsibilities:

• Ensure that Compass clinical trials are on track to reach related objectives and milestones while delivering within established timelines, budget and quality standards, including adherence to ICH, GCP, and all applicable guidelines and regulations
• Lead study oversight or CRO and vendors by tracking deliverables, metrics, and clinical milestones
• Manage and delegate daily clinical study activities for trial execution
• Lead study management, including drafting and review of study documentation, study plans, informed consent forms, system documentation, and other study related materials
• Coordinate and track of investigational drug supply shipments, site materials, and patient samples
• Oversee collection, tracking, and maintenance of clinical trial documentation and regulatory documents for the Trial Master File (TMF)
• Review vendor TMF documents for completeness, accuracy, and compliance with protocol, study plans, and applicable regulations; act as primary liaison with the CRO to ensure inspection readiness; identify issues and collaborate on resolution tasks
• Lead project meeting logistics such as: calendar management, room & equipment set up, collation of materials, and attendance tracking
• Build and maintain effective relationships with Investigators, KOLs, patient advocacy groups, regulatory agencies in implementation of study protocols, collaboration on feedback, etc.
• Partner effectively with essential subject matter experts in data management, safety/ pharmacovigilance, clinical supply and CMC, biostatistics, medical writing, quality assurance, regulatory and medical affairs
• Responsible for ad-hoc projects supporting department initiatives, as agreed with Director of Clinical Operations
• Mentor new members of the Compass Clinical Operations team, as appropriate

Qualifications:

• 5+ years of industry experience, with at least 3 years' domestic study execution experience in phase 2 and/or phase 3 oncology studies
• Experience supporting global/international studies or oncology indications is advantageous
• Bachelor's degree or equivalent, in life/health sciences or healthcare related field preferred
• Experience in CRO/vendor selection and oversight, budget projection and management, establishing clear study milestones, ensuring high-quality data delivery and report generation
• Working knowledge of all relevant guidelines, including ICH, GCP, FDA, as well as those defined by specific international regulatory bodies
• Demonstrated proficiency implementing and utilizing clinical database software, and other relevant programs such as Microsoft Office Suite
• Excellent task management, collaboration, written and verbal communication skills
• Able to maintain positive business relationships with vendors and colleagues at all levels of the organization
• Ability to drive a team-oriented environment, motivate and influence others, lead strategic discussions and interact with critical internal and external stakeholders

At Compass Therapeutics, we provide employees with an inclusive offering of benefits and a competitive compensation package. We offer our employees competitive salaries, discretionary bonuses and meaningful equity participation. Our benefits support the health and wellness of our employees; from medical, dental and vision benefits to health reimbursement arrangement, flexible spending accounts, sponsored gym membership, and an employee assistance program. We also provide company matched 401(k) and Roth 401(k) programs and other tools for financial wellness. Additional benefits include commuter reimbursement, subsidized parking, and substantial paid time off including a winter shut-down week.

We believe in growing and developing our team, and therefore, we invest in the development of strong values and culture. We are invested in employee success and provide tuition reimbursement, employee recognition programs and referral programs, training opportunities and maintain a comprehensive Performance Management cycle. While building a strong foundation, Compass culture can be seen every day in the form of curiosity, teamwork, passion, and cross functional collaboration.