William Tesch

Experience

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  Biomet

  Nov 2014 - Feb 2015

  Clinical Research Associate

  Clinical Research Associate I on a Class III Orthopedic Device study for adults needing a partial knee replacement with an intact ACL. Performed site selection, initiation, interim, and close-out visits. Created site CRFs. Used Biomet CTMS/eTMF/eCRF, electronic patient diary and questionnaires. Worked according to the Biomet 100% SDV Monitoring model.

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  ICON plc

  Nov 2015 - Oct 2016

  Clinical Research Associate I

  Clinical Research Associate I on a Phase II Oncology study for treatment of children with Acute Lymphoblastic Leukemia (ALL). Performed identification, selection, initiation, interim, and close-out visits. Used ICON CTMS, ICON eTMF, Covance labs, eCRF, IWRS, electronic patient diary and questionnaires. Worked according to the ICON Risk-Based Monitoring model. Also worked as Clinical Research Associate I on a Phase II Endocrine/Metabolic study for treatment of adults with Type II Diabetes. Performed initiation, interim, and close-out visits. Used ICON CTMS, ICON eTMF, Covance labs, eCRF, IWRS, electronic patient diary and questionnaires. Worked according to the ICON Risk-Based Monitoring model. Show less

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  PPD

  Oct 2016 - Jan 2022

  Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Delivers training on Working PRactice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate.Supports allocation activities per the local resourcing process. Supports activities of study managers to optimize the operational running of projects. Escalates appropriately any issues which may impact project deliverables.Manages and reviews systems (e.g. CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.Alerts management to quality issues, requests QA audits as appropriate, and supports direct reports and project team in providing audit responses as required.Participates in process improvement/development initiatives.Ensures understanding and facilitation of the risk based monitoring approach. Show less

  • Assoc Clinical Manager - CRA

    Sept 2020 - Jan 2022

  • Senior Clinical Research Associate II

    Sept 2019 - Sept 2020

  • Senior Clinical Research Associate II

    Oct 2016 - Sept 2019
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  IQVIA

  Feb 2022 - Dec 2022

  Senior Clinical Research Associate III

  • Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate•Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support project/site start-up phase.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Act as a mentor for new clinical staff including conducting co-monitoring and training visits.• May provide assistance with design of study tools, documents and processes.• Convey features and opportunities of study to site.• Collaborate and liaise with study team members for project execution support as appropriate. Show less

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  Parexel FSP on assignment to Pfizer

  Dec 2022 - now

  Site Relationship and Excellence Partner