Clinical Trial Manager

The Role

Reporting to the Vice President of Clinical Operations, Lakefront Biotherapeutics is hiring a Clinical Trial Manager to manage the operational aspects of specific clinical studies from study start-up through clinical study report. This includes evaluation of clinical trial timelines, budgets, quality of deliverables, clinical vendor selection and oversight of activities, site selection and site management and provision of input into clinical processes, procedures, and guidelines. The CTM drives completion of all study deliverables, ensuring the highest quality standards and regulatory guidance; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required.

What You'll Do

• Responsible for clinical study execution and oversight of all operational aspects.
• Organize and run study team meetings regularly to ensure clear and current communication, escalation of potential issues to the appropriate functional leads, and team-based problem solving and risk mitigation of any arising roadblocks.
• Contribute to the identification and selection of appropriate CROs and third-party study vendors.
• Oversee the performance of CROs and vendors to ensure the execution of the study.
• Ensure the study team members' vendor training on the study documents.
• Manage the development of clinical protocols, amendments, informed consent forms, study plans, and any other clinical research related documents, in collaboration with cross-functional team members or CRO partners.
• Establish and maintain excellent working relationships with investigators and study staff.
• Ensure studies are carried out according to the study protocol, SOPs, ICH/GCP guidelines, and study-specific manuals and procedures.
• Participate in the feasibility process for finding and selecting new study sites.
• Review and comment on CRFs and database build to ensure integration of all critical aspects of the clinical study being reflected in the clinical database.
• Review key study quality metrics (e.g., eligibility primary endpoint data,), and determine appropriate action in conjunction with the study team.
• Collaborate with Data Management to oversee data quality issues and timely execution of data cleaning efforts to ensure timely data entry and continuous data quality improvements.
• Manage study budget; review and approve clinical invoices against approved scope of work and budget, evaluate and approve vendor change orders, coordinating review and updates or revisions with cross-functional partners as necessary.
• Provide study-related guidance and leadership to internal and external partners, as appropriate.
• Other duties as assigned.

What You Bring

• BS/BA in the life sciences or a related field.
• 5-7 years of experience in clinical operations in the biotechnology or pharmaceutical industry; experience in autoimmune or rare disease experience highly desirable.
• Direct study management experience at the global level preferred.
• Demonstrated proficiency in Excel, creating metrics and dashboards for internal stakeholders.
• Experience with clinical systems including various EDC, IRT, TMF, CTMS, etc.
• Strong organizational, written and verbal communication skills.
• Willingness to travel up to 10% of the time.
• A self-starter who can take on building the operational backbone for early phase clinical studies.
• Experienced in leading Phase I-III clinical trials.
• Participation in large multi-center and/or global trials, investigational site and CRO management, data collection, study protocol compliance.
• Solid understanding of US and global regulations and guidelines (FDA, EMA, ICH).
• Experience in working in a highly matrix environment and ability to execute in the context of internal and external (vendor) cross-functional teams.
• Desire to learn and grow in scientific knowledge, managerial capabilities, and personal development.
• Willingness to take a hands-on approach.

Base compensation for this position ranges from $150,000 -165,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time. In addition, this position is eligible for participation in Lakefront Biotherapeutics' performance bonus plan. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.