Clinical Trial Manager
Posted on Wednesday, August 16, 2023
Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.
Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.
This role will assist with the day-to-day management of Orca Bio’s 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 assist with managing day-to-day activities of CROs, clinical vendors, and an in-house CRA team.
- Provide study-specific training and leadership to clinical research staff.
- Assist with monitoring overall CRO 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 at all 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.
- Participate/present at CRO, vendor and Investigator Site meetings as necessary
- Assist in onboarding and training clinical research associates.
- 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.
- BA/BS or equivalent with a minimum of 5 years of relevant clinical trial management experience
- Therapeutic experience in oncology/hematology and cell and gene therapy 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
- 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, are essential
- Ability to work independently and as part of a team
- Flexibility in responding to change or business needs
Who we are
We are scientists, engineers and business operators working with urgency to develop new therapies for patients faced with no or extremely limited options today.
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all patients who need them.
We strive to do things right. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not”, and encourage lively discourse around rethinking the status quo.
We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.
We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.
We invite you to join us and bring your unique perspective and experiences to our team.