Clinical Trial Project Manager
DxTerity is a patient-centric genomics company bringing the power of “from home” genomic monitoring to the management of immune-mediated disease. We believe that understanding underlying disease progression and immunological response are critical to the effective management of many diseases. We are developing in vitro diagnostic tests for immune response, autoimmune, and cancer applications. DxTerity is actively working with academic and pharma collaborators to longitudinally monitor disease activity and therapy response in patients with Rheumatoid Arthritis, Lupus, Multiple Sclerosis and Cancer.
DxTerity Diagnostics is seeking a Clinical Trial Project Manager to join their team based in Los Angeles, CA. This position will be responsible for leading and managing the operational activities for clinical studies to support planning, initiation, conduct and close out of clinical trials. This position will ensure clinical study activities are conducted in compliance with FDA regulations, ICH guidelines, and are in adherence with corporate and departmental Standard Operating Procedures. The Clinical Trial Project Manager will be an active member and team player of DxTerity’s clinical development initiatives. This individual will have multiple responsibilities for managing and monitoring the day-to-day logistics of clinical trials (i.e. tasks, timelines, budgets, and internal and external resources), including partnering with clinical research organizations and clinical sites to achieve program objectives in a timely fashion.
- Assists in the process of protocol finalization and manages all aspects of study execution. Uses operational and therapeutics expertise to optimize trial design and execution.
- Manages operational plans and timelines to achieve on-time enrollment and study completion. Identifies barriers to timely and successful study execution and proposes solutions to same, with regular reporting of study performance metrics.
- Manages Contract Research Organization (CRO) and Pharmaceutical Company relationships and contracts for study execution where applicable.
- Identify, evaluate and qualify clinical study sites, assist with site contracting, vendor/CRO management, training and initiation of clinical lab sites, ensure monitoring, responsibility for study files, guiding projects in conforming to requirements, and acting as point-of-contact (internal and external) for study related issues. You will also be responsible for assisting in the distribution of trial related information to relevant persons/bodies, coordinating EC/IRB approvals, and identifying and resolving problems at study sites.
- Assists with management and/or execution of site training, and ongoing educational interventions to assure compliance with study protocols.
- Assures compliance with all regulatory requirements. Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.
- Contribute to design and management of data management processes and documentation, such as data management plans, data validation specifications, data management central files, and database quality control procedures.
- Ensure development and implementation of quality processes and models. Ensure compliance of regulatory, legal, and commercial regulations in conducting research.
- Represent clinical projects to internal and external customers.
- Effectively communicate and build positive relationships with internal and external stakeholders, and facilitate timely delivery of project milestones and resolution of issues.
- Perform other duties, as assigned.
- Bachelor’s Degree (or higher) in science or health-related discipline
- 5+ years of relevant clinical trial experience in Pharmaceutical, Biotech, or CRO company
- 5+ years of clinical trial management experience
- Practical experience with Companion Diagnostic (CDx) studies is highly preferred
- Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
- Practical experience with clinical studies involving in vitro devices (IVD) a plus
- 5+ years of clinical trial experience as a CRA/Senior CRA in Pharmaceutical, Biotech or CRO company is highly preferred
- Solid organizational and business assessment skills are required
- Demonstrated ability to develop positive working relationships with individuals and teams internally and externally
- Excellent problem-solving ability
- Excellent written and verbal communication skills
- Flexible and solution seeking attitude
- Must have excellent knowledge of MS Office as well as project management and clinical trials software
- Detailed oriented with an appetite to drive tasks to completion
- Ability to work well in a rapid-pace startup environment
- Ability to work well in a group
- Ability to work independently, with minimal supervision
- Proficiency using clinical eTools (e.g. EDC, CTMS, EMR)