The Manager, Clinical Trial Monitoring manages and provides direct supervision of all staff assigned to perform Clinical Monitoring functions, working closely with Clinical Operations to ensure all program milestones and goals are obtained.
ESSENTIAL JOB FUNCTIONS:
Monitors studies and ensures they are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.
Monitors clinical study site activities and visit sites as needed. Ensures field and in-house monitoring practices are aligned and in compliance.
Tracks, collects, and reviews clinical documentation for clinical trials, or ensures this is being completed by CRO or internal staff.
Supports the PMs in ensuring CRA team is staffed to meet the monitoring demands of the project or program in compliance with approved budget and CMP. May provide back-up coverage during CRA outages / PTO.
Supports the PM in design and development of additional study related documents including (but not limited to) Informed Consent Form (ICF) templates, Monitoring Plans, Pharmacy Manuals, Medical Monitoring Plans, etc.
Formulates monitoring strategy and the forecasting of site visits.
Participates in continuous improvement initiatives for function and/or department.
Participates in development of SOPs and template documents.
Has oversight of the training and management of CRA team on all clinical aspects of the study with support from Project Management and Medical Monitoring as needed.
In collaboration with the PM, develops and implements recruitment strategy in relevant countries and sites. Leads the tracking of recruitment and revision of site-specific recruitment plans to ensure enrollment stays on target.
In collaboration with the PM, reviews trip reports, identifies issues for re-training of CRAs or sites. Escalates issues and trends per study expectations.
Reviews/finalizes trip reports according to Xeris SOPs, and as outlined in the annotated report.
Follows up with external contract CRAs regarding visit schedules, outstanding trip reports and follow up letters.
Monitors sites to include preparation and follow up as required: SQV, SIV, IMV and COVs. This will include both primary and co-monitoring visits.
Directly manages and provides mentorship to Clinical Research Associates, including establishing and reviewing appropriate metrics to ensure compliance and alignment with corporate goals.
5-7 years of clinical trial experience, including on-site monitoring, within a pharmaceutical, biotechnology, CRO and/or healthcare setting.
Bachelor’s degree, preferably in Life sciences; Master’s degree preferred.
Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
Knowledge of GCP as it relates to clinical trial management.
Ability to lead and motivate a team and collaborate across locations and disciplines.
Analytical, negotiation, meeting management, cross-functional team and leadership skills as demonstrated at a management level.
Some travel required (up to 25%). Valid current passport required.
Internal Number: 2019-1090
About Xeris Pharmaceuticals
Xeris is a specialty pharmaceutical company leveraging its novel technology technology platforms to develop and commercialize ready-to-use, room-temperature stable injectable and infusible drug formulations. The company’s proprietary XeriSol™ and XeriJect™ formulation technologies are being evaluated for the subcutaneous (SC) and intramuscular (IM) delivery of highly-concentrated, non-aqueous, ready-to-use formulations of peptides, small molecules, proteins, and antibodies using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps. XeriSol™ and XeriJect™ have the potential to offer distinct advantages over existing formulations of marketed and development-stage products, including eliminating the need for reconstitution, enabling long-term room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. These attributes may lead to products that are easier to use by patients, caregivers, and health practitioners and reduce costs for payers and the healthcare system.