Lead Study Monitor USA - Boston, United States - Clinglobal Group

Description

Job Description

Lead Study Monitor - United States of America

Clinglobal is part of a group of Animal Health Contract Research Organisations servicing the global animal health industry.

We're actively seeking a North American based senior Study Monitor to join our expanding Field Clinical Trials team This role provides the flexibility to work remotely, with occasional office visits required to Waverley, New York.

Primary Job Purpose

Lead the Monitor team across all participating countries in a specific study and actively engage in Monitoring activities. Collaborate with Study Monitors and support the Clinical Trial Project Manager to ensure studies adhere to scientific design and timelines outlined in the study Protocol, Standard Operating Procedures (SOPs), Policies, regulatory guidelines, and quality standards (e.g., VICH GL9 GCP).

Serve as the primary contact for Study Monitors and their designated clinical study sites/Investigators, providing consistent updates to the Clinical Project Manager.

Job Specific Duties and Responsibilities

• Coordinate and lead a team of study Monitors working on a particular study.
• Monitor study sites, including activities associated with study initiation, execution, close-out, and submission, and verify the data collected.
• Train sites on study protocols and GCP.
• Compile Monitor reports to report on the progress of the study and obtain corrective actions as necessary.
• Assist with site selection and evaluation.
• Serve as point of contact between the Clinglobal group and study sites/Investigators.
• Mentor and train fellow team members on study Monitor management.
• Assist the Clinical Trial Project Manager with study activities, including but not limited to reviewing draft protocols, overseeing sites' budgets and invoices, and maintenance of monitoring tools.
• Serve as point of contact for new clinical study sites/Investigators.
• Provide oversight of study master files (electronic and paper) and prepare the study files for archiving/submission.
• Liaise and coordinate with different departments, partner companies, and external partners to support the Clinical Trial Project Manager in ensuring that necessary resources are available to perform the required function at the planned time to achieve the project outcomes.
• Ensure study sites/Investigators fulfil their responsibilities to meet the agreed timelines, quality, and cost.
• Proactively identify risks that might jeopardize projects, e.g., technical feasibility, sites' suitability, timely execution, budget constraints, etc.
• Develop and maintain project management tools, including but not limited to Gantt charts, project budgets, forecasts, etc.
• Promote the organization's capabilities and values internally and externally.
• Leading global study-level documentation and required tool and systems set-up.
• Author and review monitoring-related controlled documents, where applicable.
  

Qualification, Training and Experience Requirements

• Bachelor's degree in a relevant Life Sciences field.
• Minimum of five years' experience in Study Monitoring within Animal Health or Human Pharma sectors.
• Industry knowledge, including familiarity with FDA/CVM, USDA/CVB, EMA, VICH Guidelines, Clinical Field Trials, and Data quality requirements.
• Strong technical writing and oral presentation skills in English.
• Competence in Electronic Data Capture Systems.

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.