Karen Hernandez Email and Phone Number
Experienced and award-winning Senior Clinical Project Manager with a demonstrated history of managing Phase I-IV clinical trials in pharmaceutical, consumer health, and biotech industries. Skilled in clinical operations, vendor, and project management of clinical studies. Strong research professional with a Masters of Science (M.S.) and Bachelor of Science (B.S.) focused in Neuroscience from The University of Texas at Dallas and multiple professional ceritifications with active participation in industry organizations.
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Senior Clinical Project ManagerCentessa Pharmaceuticals Jan 2024 - Present● Prompted to oversee and manage the operational aspects of two global clinical trials within Centessa’s SerpinPC Program alongside a US Phase 1 study in the Orexin Program. ● Provided project management clinical operational support for two Senior Project Directors across 4 global clinical trials across in the SerpinPC program.● Reviewed and approved study-related plans generated by CROs, vendors and ensures the documentation are in accordance with GCP, regulatory requirements and consistent with the protocol● Oversaw performance of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern and escalating when appropriate● Assisted study team with preparation for audits/inspections● Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight● Drove critical clinical trial activities including trial site activations, recruitment, and database lock to agreed upon timelines● Drove efficient decision making by acting as a key liaison between the project team and stakeholders while effectively communicating project status and progress to management, partners, and governance teams● Managed interdependencies and connections between study-level functions and ensured visibility and alignment between study program teams across SerpinPC studies. ● Provided support for the planning and preparation of documents to a quality standard required for Regulatory/Health Authority submissions● Provided oversight for the setup, maintenance, and close out of the Trial Master File and ensures it was completed and inspection-ready● 1 of 3 that was selected as a winner of Centessa's Value Centric Program award for Q1 2024 focusing on Innovation withing 3 months of joining the organization. -
Associate Director, Clinical Operations - North AmericaHaleon May 2023 - Jan 2024Weybridge, Gb● Study team leader and primary contact for assigned clinical, behavioral, decentralized and virtual trials for North and Latin America.● Responsible and accountable for the implementation of conduct and tracking of study trials in compliance with ICG/GCP, local regulations, and Haleon SOPs.● Provided operational and strategic leadership to ensure the successful delivery of trial specifications and budget requirements were met.● Led the coordination of cross-functional department activities to ensure the achievement of milestones and quality deliverables during all stages of the assigned clinical trials.● Led and participated in vendor and clinical site assessments as well as audit activities for assigned clinical trials.● Provided subject matter expertise on business initiatives and change management processes for the clinical operations department. ● Coordinate and manage indirectly up to 20 study team members and cross-functional experts involved in the set-up and delivery of the study(ies).● Completed Haleon Diploma in Digital Transformation for R&D (Certified by Haleon and endorsed by the University College of London School of Management Executive Education).● Completed Mini MBA Essentials in Deeper Human Understanding (Certified by Haleon and endorsed by the University College of London School of Management Executive Education). -
Principal Clinical Study ManagerHaleon Jul 2022 - May 2023Weybridge, Gb•Study Team Leader and primary contact for assigned clinical, behavioral, and decentralized/virtual trials for North and Latin America.•Responsible and accountable for implementation of conduct and tracking of study trials in compliance with ICG/GCP, local regulations and Haleon SOPs.•Provided operational and strategic leadership to ensure successful delivery of trial specifications and budget requirements were met.•Led the coordination of cross-functional department activities to ensure achievement of milestones and quality deliverables during all stages of the assign clinical trials.•Led and participated in vendor and clinical site assessments as well as audit activities for assigned clinical trials.•Provided subject matter expertise on business initiatives and change management processes for the clinical operations department.•Collaborated in clinical trial diversity initiates as the subject matter expert in clinical trial operations.•Nominated as a Subject Matter Expert (SME) in electronic Trial Master File (eTMF) activities and assigned as a “VeeVa Vault Clinical Champion” for the US region to help guide and educate peers in eTMF topics and system usage. -
Biomarker Program Manager Ii – Precision Medicine NeuroscienceAbbvie Apr 2021 - Jul 2022North Chicago, Illinois, Us•Responsible and accountable for 15+ concurrent global clinical studies across the AbbVie and Allergan neuroscience portfolios ranging from Phase I-IV.•Spearheaded process improvement initiatives and efficiency within the Precision Medicine Neuroscience team. •Managed the biomarker operations and logistics to align with clinical trial schedule•Key contributor of relevant clinical study documents and associated systems (including trial blueprint/protocol, ICFs, Lab manuals, eCRFs, CSRs, etc.) for biomarker endpoints.•Responsible for generating sample collection related training for the study team, sites, and vendors for each assigned trial.•Oversaw EC/IRB biomarker related inquiries, ensuring consistent responses across studies •Supported biomarker vendor selection and oversight for exploratory endpoints and/or assay development.•Responsible for forecasting, tracking, and managing study costs associated with biomarker sample and result management, bioanalytical assays, logistics and shipping. •Coordinated sample analysis by ensuring timely shipments to vendors and/or storage sites as well as supervised data transfers from both internal and external databases.•Accountable for sample management, storage, and/or destruction according to local and country regulations.•Collaborated with Data Management review eCRFs and implement edit checks in EDC and Sample management databases (i.e., StarLIMS, Labcorp’s Lablink, long term storage repositories) according to study protocol schedule.•Proactively identified and resolved operational issues related to biomarker sample collections. •Co-managed with lead biomarker scientist to support regular updates to cross-functional stakeholders for each assigned trial.•Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices and ethical guidelines in all assigned projects. •Part of interview panel on new hires for BPM positions. -
Clinical Project Manager - Prescription (Rx)Galderma Research & Development Jan 2019 - Apr 2021Zug, Ch• Responsible and accountable for several concurrent clinical studies.• Lead preparation of vendor requirements, project scope and selection of study vendors.• Managed all end-to-end study costs within the approved time and budget parameters ensuring a cost-effective result. Responsible for a combined study budget of 20 million USD.• Managed and collaborated with multi-disciplinary internal and external study teams. • Managed all components of clinical studies from study outline / protocol through CSR completion.• Accountable for delivery of all relevant study documents (e.g., Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Monitoring Plans).• Lead, planned, and executed clinical Investigator meetings, study meetings, and vendor meetings.• Partnered with CMC/clinical supplies unit to provide drug supply assumptions and contributed to design and packaging of supplies for clinical studies.• Oversaw the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participated in data and medical data reviews.• Anticipated and recognized problems in advance of potential study milestone delays and contributed to problem solving, risk mitigation and contingency planning at site and study team level to ensure successful completion of study according to timelines and budget in support of program objectives.• Ensured that all staff allocated to assigned projects were trained on the study protocol and all other study related processes, adhere to professional standards and to SOPs as well as current Good Clinical Practice (GCP) and applicable local regulations.• Managed external CRAs to completed Sponsor Oversight visits and ensured visits and reports were completed according to Galderma SOPs. • Supported Regulatory/Clinical strategies as assigned Module 5 lead for FDA IND 2021 submission for MAL 168 mg/g cream and CD14547 topical cream. -
Clinical Project Manager Associate - Prescription (Rx)Galderma Research & Development Jan 2018 - Dec 2018Zug, Ch• Served as the primary point of contact for assigned studies.• Participated in vendor selection, and established plans for data processing and data review with vendors.• Oversaw and tracked trial spending in alignment with approved budget.• Managed Clinical Research Organizations (CROs) study teams and consultants.• Developed, or assisted with development of study design, protocols, case report forms and other study-specific documents essential to appropriate implementation for clinical studies.• Worked with investigators and CRO to ensure optimal compliance and performance to the protocol, regulatory requirements, discrepancy reporting and ethical practices.• Identified and provided solutions to clinical trial concerns and/or risks.• Ensure International Conference on Harmonization (ICH), and Good Clinical Practice (GCP) procedures were followed in all study aspects.• Certified the accountability of Investigational Product and ancillary are manufactured to GMP and are used according to protocol specific instructions. • Reviewed serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks as well as ensure appreciate reporting to competent and IRB/IEC was completed in a timely manner.• Co-monitor for RD.06.SPR.108431 PK trial at all selected clinical sites as well as reviewed and approved clinical monitoring reports. -
Associate Clinical Project ManagerGalderma Research & Development Mar 2017 - Dec 2017Zug, Ch• Responsible for project management of US cosmetic and OTC claim substantiation clinical studies.• Managed all operational aspects for implementation and execution of clinical trial activities from study start-up through database lock.• Managed study-related vendors and the CROs.• Provided input onto and/or developed study related materials such as protocols, patient informed consent drafts, Statistical Analysis Plans, eCRF forms and completion guidelines, and clinical study reports.• Conduct Site Initiation, Monitoring and Close out visits at participating sites• Developed Top-Line Report and Presentation Deck Templates for upper management and commercial study result presentations. -
Cetaphil Marketing Intern (Ut Dallas Master Program Internship Requirement)Galderma Research & Development Jun 2017 - Aug 2017Zug, ChResponsibilities associated with Sensitive Skin literature Review Paper• Review scientific literature of sensitive skin• Ideate on methodologies for clinical testing of sensitive skin• Attend all team meetings.• Present project finding to key stakeholders.Responsibilities associated with Cetaphil Sensorial Testing• Set appointments for potential research subjects to come in for screening.• Interview and recruit subjects for sensorial product trials• Administer sensory product testing on human subjects• Maintained and created databases for data collection each trial• Develop data collection forms and questionnaires.• Conduct analysis on data collection and report findings by provide analysis in the form of PowerPoint presentations.• Other duties as assigned. -
Clinical Trial Administrator And Project Management (Self-Medication Bu)Galderma Research & Development Aug 2015 - Mar 2017Zug, ChAesthetics & Correctives, Prescription (Rx), and Self-Medication Business Units• Assisted Project Managers in the facilitation of study development and execution.• Managed Trial Master File and document tracking for all Clinical Development studies.• Coordinated delivery, collection, and review of clinical trial documents to and from Principle Investigator sites to facilitate IRB/IEC submission. • Coordinated financial aspects of studies including creation of purchase orders, reconciling invoices, and tracking study budget.• Managed tracking of payments for Sunshine Act reporting.• Assist in Clinical Development Department Budget.• Created Potential Principal Investigator & CRO database for Clinical Development.Self-Medication Business Unit: Project Management• Managed all operational aspects for implementation and execution of clinical trial activities from study start-up through database lock.• Managed study-related vendors and the CROs.• Provided input onto and/or developed study related materials such as protocols, patient informed consent drafts, Statistical Analysis Plans, eCRF forms and completion guidelines, and clinical study reports.• Conduct Site Initiation, Monitoring and Close out visits at participating sites• Developed Top-Line Report and Presentation Deck Templates for upper management and commercial study result presentations. -
Clinical Trial Document Management SpecialistAlcon, A Novartis Company Dec 2014 - Jun 2015Geneva, Switzerland, Ch• Performed clinical site documentation in accordance with Alcon SOPs, Good Clinical Practice, and other applicable regulatory requirements. • Coordinated delivery, collection, and review of clinical trial documents to and from Principal Investigator sites to facilitate IRB/IEC submission. • Ensured accuracy and quality of regulatory documents submitted by sites for site initiation packets. • Maintained site document tracking and information in clinical trials database. -
Clinical Research Assistant Ii/Study CoordinatorRetina Foundation Of The Southwest Sep 2014 - Dec 2014Dallas, Texas, Us• Assisted Principal Investigators in conducting clinical trials using FDA approved practices and maintained the protection of human subjects while advancing trial goals. • Submitted invoices for applicable charges covered by funded research studies. • Served as site lead for all assigned clinical studies ensuring that studies are delivered according to Sponsor requirements on time and with high quality. • Prepared Institutional Review Board (IRB) materials related to initial review and approval of assigned studies. • Assisted with regulatory compliance including preparing IRB materials for approval of protocol amendments, as well as completing IRB continuing review reports. • Continued responsibilities as Clinical Research Assistant for assigned trails in the Macular Function and Rose-Silverthorne Laboratory. -
Clinical Research Assistant/ Back-Up CoordinatorRetina Foundation Of The Southwest Feb 2014 - Aug 2014Dallas, Texas, Us• Assisted Principal Investigator in conducting clinical trials using FDA approved practices and maintained the protection of human subjects while advancing trial goals. • Interviewed and recruited patients for clinical trials and ensured inclusion and exclusion criteria was met upon enrollment. • Performed basic to advance visual testing which included visual acuity, measuring fixation stability using mircopremitry, and Optical coherence scans. • Electroretinography (ERG) technician for the Rose-Silverthorne Laboratory. • Maintained and created databases for each clinical trial in the Macular Function Laboratory. • Managed all administrative duties associated with each assigned trail and submitted Case Report Forms to specific sponsors and associate clinical. -
Patient Access ServicesTexas Health Resources Aug 2012 - Feb 2014Arlington, Texas, UsProvided registration to outpatients/inpatients having hospital-based testing or procedures inmultiple departments.Maintained confidentiality of patients’ medical, economic, and demographic record.Attained authorization and verified insurance eligibility in addition to collect required payment.Provided information regarding billing, complaint process, patient rights, and HIPAA.Coordinated weekend Bed-Status Control Department. -
Patient Access Registrar (Emergency Department)Medical City Healthcare May 2011 - Sep 2011Dallas, Texas, UsUpheld high confidentiality of patients’ biographical, medical, and financial information.Interviewed patients to obtain all necessary account information while maintaining exceptional customer service skills.Ensured that all necessary signatures were obtained for treatments. -
File ClerkFletcher, Farley, Shipman & Salinas Llp Jan 2011 - May 2011Dallas, Tx, UsHighly involved in organization of all filing documents.Maintained confidentiality of legal, public, and company records.Answered phones and performed general office duties. -
Office Assistant/ Assistant Coordinator For ContractsThe University Of Texas At San Antonio Feb 2010 - Aug 2010San Antonio, Tx, UsRe-established business partnerships with recruiting agencies around the world.Processed applications for the Intensive English Program.Maintained confidentiality of agency, faculty, and student records. -
On-Campus Recruiting Student AssistantThe University Of Texas At San Antonio Mar 2009 - Nov 2009San Antonio, Tx, UsAssisted students and employers during on-campus interview sessions.Maintained confidentiality of student and employer records.Demonstrated ability to verbally communicate with people on a corporate and personal level.Answered phones and performed general office duties.
Karen Hernandez Education Details
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The University Of Texas At DallasApplied Cognition And Neuroscience -
The University Of Texas At DallasNeuroscience -
The University Of Texas At San AntonioGeneral
Frequently Asked Questions about Karen Hernandez
What company does Karen Hernandez work for?
Karen Hernandez works for Centessa Pharmaceuticals
What is Karen Hernandez's role at the current company?
Karen Hernandez's current role is Senior Clinical Project Manager.
What schools did Karen Hernandez attend?
Karen Hernandez attended The University Of Texas At Dallas, The University Of Texas At Dallas, The University Of Texas At San Antonio.
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