reports to the VP of Clinical Operations (or above). The right candidate will
possess an understanding of Clinical Operations for successful execution of
multiple clinical trials primarily in pediatric and adult rare diseases in various
phases of development. Experience in
Neurology (adult and pediatric) is preferred.
Responsibilities of this position involve the day to day management and oversight of clinical trials in collaboration with a dynamic Clinical Development team and our various partners.
· Independent management of the operational aspects of Passage Bio’s clinical trials, including vendors such as CROs, biomarker and specialty laboratories, and clinical trial sites
· Identification and qualification of clinical trial sites and investigators in partnership with the CRO including management of key relationships
· Participation in the day to day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and vendor labs
· Management of clinical trial budgets and execution timelines.
· Leads internal team meetings for trial management.
· Facilitation/participation in investigator meetings, kick-off meetings, monitoring training, clinical trial training, and other as needed meetings.
· Participation in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.
· Attendance at site visits to ensure oversight of CRO monitors and effective collaboration with Investigators and site staff.
· Review trial reports and metrics to ensure timely collection of clinical data, samples, and lab results.
· Collaboration on SOP development and promotion of standardized clinical business tools.
· Development and review of specific trial documents e.g. informed consent forms, trial guidelines, operations manuals, training materials.
· Development of action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
Participation in the preparation of
presentations of trial data for internal and external parties (management
review, scientific meetings, and advisory boards).
· Minimum Education Required: Bachelor's degree in a scientific discipline required. Advanced scientific degree is preferred.
· The candidate should ideally have 4-6+ years in trial management with a sponsor company managing various phase clinical trials.
· Experience in various phases of clinical trials and various therapeutic areas, including neurology, would be helpful.
· Experience in CRO, vendor and laboratory oversight is required.
· Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
· Creative problem solver with excellent communication and public speaking skills.
· Ability to adapt to a changing, fast-paced environment
· Strong interpersonal and organizational skills are needed, with a high degree of attention to detail. Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, etc.).
· Ability to travel for up to 30% of time, both domestic and international, may be needed.
Detailed knowledge of GCP and
current US FDA regulations, and knowledge of other relevant global regulatory
requirements a plus.