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 identified by the company.

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Clinical Data Manager

Clinical Operations

Working within the Clinical Operations Department and the Data Management functional unit, the Clinical Data Manager is responsible for the clinical data management function of Trial Runners. This includes development of CRF/eCRF design, generation of the data clean-up specifications, overseeing database design and testing, review of clinical data, and the creation and maintenance of study documentation. Responsible for planning and implementing policies, procedures, practices and strategy for the data management function and managing the direction, planning, and execution of the data management activities, including vendor relationships, budgets and timelines, in order to meet corporate goals and objectives.

RESPONSIBILITIES:

  • Manage, coach, appraise, discipline, direct and resource Clinical Data Associate (CDA) to achieve results.
  • Interact with Clinical Operations, Safety Team, SAS Programmers, and Statistics to define the necessary listings needed for the support of data clean-up and database finalization.
  • Manage review of listings within Clinical Data Management (CDM) for quality, content, format and output
  • Allocate resources to the study team in support of the quality review of final summary tables and listings used in the preparation of the Clinical Study Report (CSR), Interim Reports of sponsor defined analysis
  • Manage interaction with sponsors to ensure compliance to standards, timelines, relevant guidelines and expectations of clinical data management activities
  • Identify and defines priorities and timeline issues
  • Provide data management function SOP review and development, employee training, and associated requirements
  • Procure and oversee outside vendors and consultants as required
  • Manage data management activities with regard to protocol review, study activation, data review, maintenance and quality for multi-institutional sites
  • Contribute to development and use of department performance metrics to monitor the data collection process and identify process improvement opportunities
  • Attend and participate in Study Project Kick Off meetings
  • Create and maintain Data Management Plans
  • Perform and/or Manage data entry, database design, verification and validation activities within data management group and among various sources of clinical data
    • CRF Design
    • EDC database build, eCRF screens
    • Edit Check Specifications and programming
    • Manual Check Specifications
    • User Acceptance Testing
    • 3rd Party Data Transfers
    • Annotated CRF
    • User Access and Training of EDC
    • Data Listings for review
    • Medical Coding and review
    • Query Management
    • Project Database Change Requests
  • Database Lock and End of Study Management
  • 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

Requirements

  • Minimum 4 years’ experience in Clinical Data Management in a biopharmaceutical setting (industry and/or CRO)
  • Minimum 1-year experience leading a data management team with direct reports
  • Demonstrated ability to effectively manage and prioritize multiple programs
  • Understanding of clinical data management applications and systems
  • Experience in developing data management procedures and processes
  • Excellent written and oral communication skills
  • Proficient knowledge of medical terminology and expertise with ICH/GCP and regulatory compliance guidelines for clinical trials
  • Solid understanding of clinical drug development process
  • Good computer skills (MS Office products, word processing, spreadsheets)
  • High attention to detail and accuracy and ability to manage multiple project teams
  • Excellent prioritization and organizational skills and demonstrated ability to delegate appropriately
  • Ability to work on extremely complex problems where analysis requires evaluating various factors
  • Ability to exercise independent judgment in developing methods, techniques and evaluation criteria for obtaining results
  • Advanced people management skills and positive flexible outlook
  • Excellent interpersonal communication skills and works effectively on cross-functional teams

EDUCATION REQUIREMENTS

  • Bachelor’s Degree in Life Sciences/Computer Sciences/Mathematics/Statistics or related field, or significant relevant work experience required

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

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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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