Join Our Team

Our team brings value to the research industry through experience, expertise, and passion. If you thrive when facing challenges and tight timelines and want to apply your skills in the clinical research field to a rewarding career, join the Trial Runners team.

Risk-Based Manager

Clinical Operations

Working within the Clinical Operations Department, the Risk-Based Manager (RBM) applies professional knowledge and skills in implementing clinical trials in accordance with ICH/GCP guidelines and Trial Runners Standard Operating Procedures (SOPs); with particular emphasis on risk-based management and monitoring techniques. This role serves as the primary liaison between Clinical Project Teams and the investigative sites, focusing on site engagement to achieve patient safety and data integrity.

RESPONSIBILITIES:

  • Produce risk-based assessment plan, training, and analytics
  • Devise continuous improvement trainings to decrease risk and increase operational efficiency using data analytics supplied from remote data review, data management, and risk-based analytics supplied by a statistical programmer
  • Assess training needs and organize/recommend appropriate training at the investigational site. Recommend appropriate follow-up responses to issues at clinical sites including potential deficiencies in documentation, communication, and the need for additional training when warranted
  • Conduct Pre-Study, Study Initiation, Interim Monitoring, and Close-Out visits
  • Complete monitoring trip reports, confirmation and follow up letters for all monitoring visits
  • Review TMF required documents and conduct risk assessments to verify quality and ensure compliance with the protocol and critical processes
  • Actively support site staff to take greater ownership of process compliance and accurate data reporting
  • Identify, quantify, and visualize study risks, based on a continuous process of structured risk assessment
  • Efficiently review high-value data at individual study sites and effectively manage issues, evaluate risks, and perform on-site visits when for-cause is determined
  • Ensure safety at investigative sites by verifying proper recording and reporting of Serious Adverse Events through risk-based analysis
  • Creates e-binder, regulatory binders, and procedure binders
  • May participate in database user acceptance testing (UAT) to ensure parameters and edit checks are performing as expected.

Requirements

  • Verifiable experience in Ophthalmology highly preferred
  • Working knowledge of FDA and International Conference of Harmonization and Good Clinical Practices (ICH/GCP) Guidelines
  • Knowledge and experience on site operations and data management
  • Keen comprehension of the assessment and management of risks including the ability to analyze aggregated data and interpret risk indicators to evaluate site performance and data quality
  • Excellent written and communication skills
  • Strong attention to detail and accuracy
  • Strong operational, organizational, presentation, documentation and interpersonal skills
  • Ability to travel 25% or more when needed to support project requirements
  • Excellent computer skills – Excel, Word, PowerPoint, Microsoft Outlook

EDUCATION Requirements

  • Bachelor’s Degree in Life Sciences related field, or significant relevant work experience required
  • Minimum 2 years clinical research industry experience

NOTE: This job description is not intended to be all inclusive. Employee may perform other related duties as assigned to meet the ongoing needs as delegated by the company

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Clinical Project Manager

Clinical Operations

Working within the Clinical Operations Department and the Project Management functional unit, the Clinical Project Manager is responsible for planning and executing the operational aspects of clinical research, while working closely with various individuals and departments internally and externally. This position is the primary point-of-contact and liaison with the Sponsor. The Project Manager will oversee the conduct of clinical trials in compliance with applicable FDA and ICH/GCP guidelines, global regulations, and Trial Runners Standard Operating Procedures.

RESPONSIBILITIES:

Act as a liaison with sponsor to oversee clinical studies to include:

  • Ensure study remains within scope and out of scope activities are identified and handled as appropriate
  • Perform risk management and contingency planning activities to ensure that all potential study risks, such as delays in study milestones and increased study costs, are managed in a proactive and efficient manner
  • Facilitate team coordination and work flow for projects
  • Develop and Monitor project timelines and resources allocated
  • Communicate up-to-date information regarding project progress to all relevant interested parties
  • Provide strategic input on enrollment and contingency planning
  • Vendor management to include procurement and negotiation of contracts
  • Lead project team meetings to ensure on-time deliverables
  • Assist in protocol development and CRF design
  • Track departmental carbon footprint and implement policies, procedures, and practices to decrease negative impact on the environment
  • Ensure all departmental purchases and practices reflect the company’s corporate citizenship policy
  • May manage clinical study budget and contracts

Requirements

  • Knowledge of FDA and International Conference of Harmonization and Good Clinical Practices (ICH/GCP) Guidelines
  • Excellent written and verbal communication skills and detail-oriented skills
  • Various computer skills – Excel, Word, PowerPoint, Microsoft Outlook
  • Extensive understanding of principles, concepts, practices, and standards of clinical research
  • Excellent leadership skills
  • Excellent organizational skills, including the ability to handle multiple assignments
  • Possess full working knowledge of all required clinical study tasks and elements from study initiation through completion
  • Ability to ensure a good customer relationship is established and maintained

EDUCATION Requirements

  • Bachelors Degree in science/health related field required
  • 4-6 years of clinical experience in the pharmaceutical/CRO industry

NOTE: This job description is not intended to be all inclusive. Employee may perform other related duties as assigned to meet the ongoing needs as delegated by the company

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General Resume Submission

Please use this link to submit a CV/Resume for a position you don't see currently listed. We will keep your CV on file and contact you if an opening should occur.

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