Kristopher Watson Email & Phone Number

Washington, Dc, Us

- Support the day-to-day operations of assigned trials and responsibilities to ensure completionper established project team goals and objectives in compliance with applicable GCP/ICHguidelines and other regulatory requirements- Responsible for maintaining accurate and up-to-date trial information within relevant trackingsystems and provide regular updates as requested to trial team and other defined stakeholders- Participate in the development of core trial documents and trial level plans, as requested- Participate in or lead trial related systems set-up including implementation and maintenance ofappropriate systems, standards and processes to ensure quality across investigative sites,vendors and data- Participate in feasibility assessment and selection of countries and sites for trial conduct- Participate in CRO and vendor set-up and management during clinical trial execution- Participate in or facilitates site engagement and communications with investigators and/or staffto support trial milestones and deliverables- Participate in CRO and vendor set-up and management during clinical trial execution, asrequested by clinical trial lead and/or clinical team- Ensure quality and completeness of TMF for assigned clinical trials- Participate in trial team meetings and manage associated documentation- Participate in data cleaning and data review activities- Participate in or lead set-up and implementation of effective investigator and site monitortraining- Participate in the coordination and implementation of patient-focused strategies for assignedtrials

Washington, District Of Columbia, United States

•Supported lead Clinical Trial Managers with start-up, maintenance, and closeout activities for Phase I trials on Inflammation, Virology, HIV, and COVID therapeutic areas resulting in successfully closing out six studies.•Developed extensive trial documentation for 11 studies, such as: study plans, protocols, and ICFs resulting in a 100% compliance rate with FDA Regulations, ICH-GCP Guidelines, and SOPs.•Performed clinical site oversight for up to 26 sites per study, including management of site visits and monitoring, review of trip reports, and resolving EDC queries while consistently meeting database milestones.•Executed all eTMF activities for up to 11 studies concurrently in Veeva Vault from startup to closeout ensuring regulatory compliance and data transparency.•Created the eTMF Functional QC Completeness Check Form optimizing the eTMF reconciliation process in Early Phase Trials •Managed lab data, sample storage, shipment, and end of study sample reconciliation for 10,000+ collected samples per study resulting in high-quality data for analysis.•Collaborated cross functionally with BioMarker/Analytical Operations, Patient Safety, Quality & Medical Governance, and external vendors resulting in the effective resolution of all site performance, safety, quality, and compliance issues.•Reviewed and reconciled protocol deviations resulting in the prevention of IPDs and maintaining data integrity and validity.•Mentor and principal trainer to six incoming Early Phase Clinical Project Assistants on Veeva Vault eTMF allowing seamless onboarding into Clinical Operations.

Washington, District Of Columbia, United States

•Supported lead Clinical Trial Managers with start-up, maintenance, and closeout activities for Phase I trials on Inflammation, Virology, HIV, and COVID therapeutic areas resulting in successfully closing out six studies.•Developed extensive trial documentation for 11 studies, such as: study plans, protocols, and ICFs resulting in a 100% compliance rate with FDA Regulations, ICH-GCP Guidelines, and SOPs.•Performed clinical site oversight for up to 26 sites per study, including management of site visits and monitoring, review of trip reports, and resolving EDC queries while consistently meeting database milestones.•Executed all eTMF activities for up to 11 studies concurrently in Veeva Vault from startup to closeout ensuring regulatory compliance and data transparency.•Created the eTMF Functional QC Completeness Check Form optimizing the eTMF reconciliation process in Early Phase Trials •Managed lab data, sample storage, shipment, and end of study sample reconciliation for 10,000+ collected samples per study resulting in high-quality data for analysis.•Collaborated cross functionally with BioMarker/Analytical Operations, Patient Safety, Quality & Medical Governance, and external vendors resulting in the effective resolution of all site performance, safety, quality, and compliance issues.•Reviewed and reconciled protocol deviations resulting in the prevention of IPDs and maintaining data integrity and validity.•Mentor and principal trainer to six incoming Early Phase Clinical Project Assistants on Veeva Vault eTMF allowing seamless onboarding into Clinical Operations.

Raleigh-Durham-Chapel Hill Area

• Collaborated with all relevant project stakeholders to identify project scope objectives ensuring technical feasibility for theexecution of clinical translation/transcription projects in Phase 1-3 studies.• Facilitated the translation, transcription, and adaptation of clinical trial documents (Protocol Amendments, Medical Reports,Clinical Contracts, ICFs, Imaging Manuals) resulting in successful and timely study conduct.• Developed the company’s SOP template for Clinical Transcription significantly reducing project inconsistencies, operationalchallenges, and ISO17100 non-compliance.• Successfully lead and trained the Clinical Project Analyst Transcription Team for all US/EU/Asian-Pacific Studies enhancingfunctional efficiency across multiple time zones and reducing turnaround times for all non-US clinical projects.• Created early budget estimates to assess costs for transcription and translation work for global clinical trials increasing revenue bynearly $200,000 monthly and over $2M annually respectively.• Collaborated with internal and external clients to identify any budget or scope issues subsequently lessening risks and impact toprotocol amendments, study timeline changes and study design changes.• Exemplified meticulous organizational skills by maintaining over 3,000 independent projects annually, distinguishing myself asthe department’s most prolific project manager.

Raleigh-Durham, North Carolina Area

• Collaborated with all relevant project stakeholders to identify project scope objectives ensuring technical feasibility for theexecution of clinical translation/transcription projects in Phase 1-3 studies.• Facilitated the translation, transcription, and adaptation of clinical trial documents (Protocol Amendments, Medical Reports,Clinical Contracts, ICFs, Imaging Manuals) resulting in successful and timely study conduct.• Developed the company’s SOP template for Clinical Transcription significantly reducing project inconsistencies, operationalchallenges, and ISO17100 non-compliance.• Successfully lead and trained the Clinical Project Analyst Transcription Team for all US/EU/Asian-Pacific Studies enhancingfunctional efficiency across multiple time zones and reducing turnaround times for all non-US clinical projects.• Created early budget estimates to assess costs for transcription and translation work for global clinical trials increasing revenue bynearly $200,000 monthly and over $2M annually respectively.• Collaborated with internal and external clients to identify any budget or scope issues subsequently lessening risks and impact toprotocol amendments, study timeline changes and study design changes.• Exemplified meticulous organizational skills by maintaining over 3,000 independent projects annually, distinguishing myself asthe department’s most prolific project manager.

Chapel Hill, Nc