Job Description

Clinical Trial Project Manager - United States of America

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 Trial 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.

Primary Job Purpose

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.

Job Specific Duties and Responsibilities

• 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.

Qualification, Training and Experience Requirements

• DVM or related Life Sciences degree, accompanied by a minimum of five years of experience in Field Clinical Trials (FCT) and Project Management.
• Ideal candidates should demonstrate industry awareness, including expertise in the pharmaceutical sector, familiarity with FDA/CVM, USDA/CVB, EMA, VICH Guidelines, Clinical Field Trials, and data quality requirements.

Important Note to Applicants

This is a remote position with potential for regular travel.

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The Company complies with local and international data protection and privacy legislation. This includes transparency in the processing of personal information processed about job applicants during the recruitment process. By applying for this position, applicants agree to the processing of their personal data in accordance with our recruitment procedure and Privacy Notice available from our website.

As part of the hiring process, candidates need to willingly take part in personality and behaviour assessments to determine a good fit for the job role. These assessments assist with evaluation of candidates in a fair and thorough manner. All information gathered are kept private and only used to assess suitability for the job role. The Company may perform criminal and/or other relevant checks (as is relevant to the position) on all applicants applying for this position.

Job Tags

Full time, Contract work, Work at office, Local area,

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