Clinical Trial Manager

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Exciting opportunity to join Orca Bio's newly created early stage clinical team! You will assist with the day-to-day management of our early stage (pre-phase 3) clinical studies and ensure that the studies are delivered on time, within budget, with high quality data, and in compliance with the protocol, standard operating procedures, good clinical practice guidelines, and other applicable laws and regulatory requirements. You will also assist with managing day-to-day activities of our clinical vendors and in-house CRA team.

Responsibilities:

• Provide study-specific training and leadership to clinical research staff.
• Assist with monitoring overall CRA, site and vendor performance and study progress as it relates to timelines, budgets, quality, and compliance with relevant regulations and guidelines.
• Identify potential study issues, and ensure optimization of delivery of scoped services and internal resources.
• Leverage operational and therapeutic expertise to optimize trial design and execution.
• Determine, develop, and implement tracking and reporting specifications.
• Work with the study team to design clinical protocol; provide input for the design of the ICF template, source documents and CRFs.
• Prepare and/or review study-related documents to include clinical logs, forms, manuals, and guidelines.
• Track and manage subject recruitment across study sites.
• Oversee the management of study monitoring visits, and the review and approval of monitoring reports.
• Mentor and develop in-house CRA team.
• Monitor site performance on an ongoing basis and escalate any infringements, breaches, and misconduct, fraud, and negative trends. 
• Oversee ongoing protocol deviation tracking, reporting, and trending.
• Oversee the collection, review and filing of site essential documents, and maintenance of the TMF.
• Follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies.
• Participate in the planning of quality assurance activities, internal and external audits/inspections and assist with resolution of audit/inspection findings.
• Provide support for site initiation, interim monitoring, and close out visits as needed. 
• Assist with development and management of clinical budgets and contracts.
• Collaborate with cross functional teams to create and implement study-specific tools (metrics reports, patient profiles) to ensure clean data.

Requirements:

• BA/BS or equivalent with 5+ years of relevant clinical trial management experience.
• Therapeutic experience in oncology/hematology and cell and gene therapy preferred.
• Prior experience with early stage clinical trials at a small biotech/life science company preferred.
• Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures.
• Experience with Trial Master File management according to the DIA reference model.
• Experience operating within various site EMR/EHR systems.
• Experience using eTMF, EDC (IBM experience ideal) , CTMS, and other vendors systems/portals.

Preferred Qualities:

• Entrepreneurial and passionate; enjoys working in a fast-paced, collaborative environment.
• Highly detail oriented with special attention to quality and quality control.
• Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize. 
• Excellent problem resolution and organizational skills; desire to improve upon established processes.
• Strong interpersonal skills, including verbal and written communication, and a sense of humor.
• Ability to work independently and as part of a team.
• Flexibility in responding to change or business needs.

The anticipated annual salary range for this job will be based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. You will also be eligible to receive