The Secrets to Implementing a Successful Metrics Program...• Ensure all trial deliverables are met according to timeline, budget, and resource requirements • Partner closely with
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Secrets to Implementing Successful Metrics Programs
Mike Fitzpatrick04 Sep 2019
Agenda
Poll Question
My Analytics Journey – Challenges and Recommendations
Case Study - Treehouse Brewing
Key Takeaways
Clinical trial teams excel at
leveraging data in my company.
“The ability to take data – to be able to understand it, to process it, to extract value from it, to visualize it, to communicate it’s going to be a hugely important skill in the next decades”
Google’s Chief Economist Hal Varian – 2009 Interview
Poll Question:
Strongly Agree
5
Agree 4
Neither 3
Disagree 2
Strongly Disagree
1
Traditional Clinical Trial Manager Skills &
Qualifications
do not optimize
Clinical Trial Execution
My Hypothesis….
Responsibilities (Trial Execution)
• Day to day management of assigned clinical trial to ensure deliverables are met in all phases of trial
• Communication to internal team members on deliverables and ensuring timelines are met
• Manage trial feasibility process
• Work closely with Rare Disease or Infectious Disease Clinical Operations Strategy Leader to implement Operations plan for Clinical Study Teams.
• Drafting site materials including training, manuals and support documentation
• Monitoring of clinical data to ensure timely entry and readiness for data review meetings
• Periodic review of clinical data
• Review of clinical monitoring reports to ensure timely completion and identification of issues
• Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
• Maintain trial metrics
• Ensure trial is conducted in accordance to company and ICH/GCP standards including multiple regions in global trials
• Support the CRO in testing clinical trial systems/databases (i.e. UAT)
• Develop and maintain strong, collaborative relationships with key stakeholders within company
• Lead strategic planning and management of all study and team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
• Lead development of overall clinical strategic operations plan for assigned projects including timelines, internal and external costs, CRO/Vendor Oversight Plans, key deliverables and risk/mitigation strategy.
• Provide oversight of study timelines and trial execution.
• Ensure all trial deliverables are met according to timeline, budget, and resource requirements
• Partner closely with Clinical Research Organization (CRO) interactions, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, and project master files).
• Monitor oversight of study progress including: CRO and third party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable.
• Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensures that performance expectations are met.
• Collaborate with internal medical director in development and authorship of study protocol
• Participate in Case Report Form design, user acceptance testing in partnership with Data Management.
• Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc.
• Contribute to and/or author clinical sections of regulatory documents including Investigators’ Brochures, safety updates, and responses to Health Authority / Ethics Committee questions
• Identify potential study issues, proactively recommending and implementing solutions or corrective actions, as needed.
• Develop and actively manage Site/Investigator relationships; serve as a liaison and resource.
• Organize, schedule and attend internal & external team trial-specific meetings.
• Perform occasional travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
• Assist Senior Clinical Trial Manager in management of clinical programs, preparation and execution of sound clinical development strategies, and Clinical Operations Department Initiatives.
• Participate in the development, review and implementation of departmental SOPs and processes.
Two randomly selected CTM job postings from Linkedin, Aug 2019
• Day to day management of assigned clinical trial to ensure deliverables are met in all phases of trial
• Communication to internal team members on deliverables and ensuring timelines are met
• Manage trial feasibility process
• Work closely with Rare Disease or Infectious Disease Clinical Operations Strategy Leader to implement Operations plan for Clinical Study Teams.
• Drafting site materials including training, manuals and support documentation
• Monitoring of clinical data to ensure timely entry and readiness for data review meetings
• Periodic review of clinical data
• Review of clinical monitoring reports to ensure timely completion and identification of issues
• Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
• Maintain trial metrics
• Ensure trial is conducted in accordance to company and ICH/GCP standards including multiple regions in global trials
• Support the CRO in testing clinical trial systems/databases (i.e. UAT)
• Develop and maintain strong, collaborative relationships with key stakeholders within company
• Lead strategic planning and management of all study and team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
• Lead development of overall clinical strategic operations plan for assigned projects including timelines, internal and external costs, CRO/Vendor Oversight Plans, key deliverables and risk/mitigation strategy.
• Provide oversight of study timelines and trial execution.
• Ensure all trial deliverables are met according to timeline, budget, and resource requirements
• Partner closely with Clinical Research Organization (CRO) interactions, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, and project master files).
• Monitor oversight of study progress including: CRO and third party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable.
• Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensures that performance expectations are met.
• Collaborate with internal medical director in development and authorship of study protocol
• Participate in Case Report Form design, user acceptance testing in partnership with Data Management.
• Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc.
• Contribute to and/or author clinical sections of regulatory documents including Investigators’ Brochures, safety updates, and responses to Health Authority / Ethics Committee questions
• Identify potential study issues, proactively recommending and implementing solutions or corrective actions, as needed.
• Develop and actively manage Site/Investigator relationships; serve as a liaison and resource.
• Organize, schedule and attend internal & external team trial-specific meetings.
• Perform occasional travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
• Assist Senior Clinical Trial Manager in management of clinical programs, preparation and execution of sound clinical development strategies, and Clinical Operations Department Initiatives.
• Participate in the development, review and implementation of departmental SOPs and processes.
• At least 5 five years of trial coordination experience in a clinical research environment, some should be in industry
• Advanced degree preferred or Bachelor’s in a science-based subject
• Relevant therapeutic experience in global setting
• Solid understanding of drug development
• Good project management skills
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
• Excellent verbal and written communication skills
• Good organizational skills and attention to detail
• BS/BA degree in science or similar area.
• 2-5 years’ experience as integral Team support for clinical trials for or within the biotech or pharmaceutical industry, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, protocol, ICF, CRF, CSR development and review and knowledge of basic data management/biostatistics processes including Electronic Data Collection (EDC) and Pharmacovigilance.
• Knowledge of global clinical trial management in fast paced CRO outsourced environment, including interpretation and implementation of FDA regulations/ICH guidelines, is required.
• Excellent oral and written communications.
• Ability to establish study operational plans and strategy. Requires a balance of scientific and operational/project management and team leadership expertise.
• Strong computer skills including knowledge of Microsoft Excel, Word, PowerPoint and Outlook.
• Ability to work within established timelines, in a fast paced environment.
• Excellent organizational and priority management skills.
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.