Clinical Project Manager (Animal Health)

Clinglobal Group•Fort Collins, CO

18h•Remote

About The Position

Clinaxel is part of a group of Animal Health Contract Research Organizations servicing the global animal health industry. We're actively seeking a North American based Clinical Project Manager to join our expanding field clinical trials team. This role provides the flexibility to work remotely, with occasional office visits required. This position presents an exciting opportunity for professional growth and development in the Animal Health industry.

Requirements

DVM or related Life Sciences degree
Minimum of five years of experience in Field Clinical Trials (FCT) and Project Management.
Industry awareness, including expertise in the pharmaceutical sector
Familiarity with FDA/CVM, USDA/CVB, EMA, VICH Guidelines, Clinical Field Trials, and data quality requirements.

Nice To Haves

Animal Health clinical experience highly preferred

Responsibilities

Coordinate Field Clinical Trials (FCT) processes and resources, including data management, Monitors, QA support, legal, finance teams, study Investigators, laboratories, and couriers.
Manage communication with the Sponsor and ensure FCT's quality and timely completion per company SOPs, policies, practices, and Sponsor's expectations.
Coordinate FCT across all their phases (e.g., feasibility assessment, quotation, set up, live phase, close-out, reporting, and study master file compilation), liaise with the responsible team members for the services performed within the group, and manage the relationship with external partners and vendors.
Ensure projects complete their life cycle and deliverables meet the agreed timelines, quality, and cost.
Report to management and Sponsors on the status of projects, including budgets and timelines, through the implementation and coordination of regular project review meetings.
Proactively identify risks that might jeopardize projects, e.g., technical feasibility, availability of resources, timely execution, budget constraints, etc.
Develop and maintain project management tools, including but not limited to Gantt charts, project budgets, forecasts, etc.
Liaise and coordinate with different departments, partner companies, and external partners to ensure that necessary resources are available to perform the required function at the planned time to achieve the project outcomes.
Serve as primary project contact with Sponsors to ensure that communication and reporting schedules are followed.
Develop site training materials including study specific materials and GCP materials.
Mentor and train fellow team members on FCT management.
Promote the organization's capabilities and values internally and externally.
Fulfil Monitor responsibilities within GCP and non-GCP studies, where applicable.
Contributing to study-level risk assessments.
Identifying and resolving issues at a global level.
Leading global study-level documentation and required tool and systems set-up.