Marcela Cook

Experience

• 

  Wargrave Surgery

  Apr 2004 - Dec 2004

  Dispenser

  My experience included dispensing of medications and supplies including medications for branch clinics, endorsing private & NHS scripts, dealing with orders and assisting patients face to face and on the phone

• 

  Twyford Surgery

  Jan 2005 - Jul 2005

  Dispenser

  I was responsible for general duties such as dispensing of medications, assisting patients on day to day basis, dealing with orders and inventories, communicating with medical representatives, processing of repeat prescriptions and working closely with local pharmacies and nursing homes

• 

  Vantage Chemist

  Jul 2005 - Mar 2006

  Pharmacy Technician / Dispenser

  I have expanded my knowledge since I was responsible for administration, filling and keeping patient’s records up to date, I have assisted customers face to face and on the phone, worked on own initiative, dealt with day to day problems and complications, processed end of month paperwork, dealt closely with local GP’s and nursing homes and handled register and CD medications

• 

  Pharmanet

  Apr 2006 - Mar 2008

  Performed data review and query generationAssisted in defining edit checks to be programmed for each studyReviewed programmed edit checksTracked study progress and issued periodic status reportsUpdated the database to correct errorsCoded Case Report Form (CRF) verbatim terms using company or sponsor supplied dictionariesReviewed electronic data received from external vendors or suppliers (e.g. central laboratories)Participated in the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor Show less Entered data from Case Report Forms (CRFs) into databaseVerified data by performing second entry and resolving discrepanciesPrimary role for one or more projects Tracked the progress of CRF receipt and entryCoordinated CRF workflowIdentified issues which the quality and timeliness of project completion and implemented solutionsPrepared, maintained and communicated data entry conventions and other study specific issuesTrained data entry staff on data entry procedures and systemsCompleted all quality control measures necessary for the finalization and transfer of the database Show less

  • Data Analyst

    Oct 2007 - Mar 2008

  • Associate Data Analyst

    Dec 2006 - Sept 2007

  • Data Technician

    Apr 2006 - Nov 2006
• 

  Pharmanet

  Mar 2008 - Aug 2010

  Safety Associate I

  Review and processing of serious adverse events Prepare safety data reports for submissions to clients in ARISg 5.0 and ARGUSAssist with expedited Safety Reports for submission to Regulatory AuthoritiesAssist in representation of Global Safety and Pharmacovigilance group at project team and client meetingsLiaison with Clinical team and clients to ensure compliance with safety & pharmacovigilance SOPsAssist with Regulatory submissions, i.e. Development Safety Update Report, Periodic Safety Update ReportsAssist with set up and other safety lead activitiesSAE reconciliation responsibilitiesMaintain current knowledge of all applicable guidelines and regulations relating to safety reporting Show less

• 

  InVentiv Health Clinical

  Aug 2010 - Jan 2018

  - Collaborate with Sponsors and internal colleagues for multiple projects- Participate as the GSPV project lead in project launch meetings - Develop detailed project specific Safety Monitoring Plans - Attend/present at Investigator meetings where applicable- Develop and maintain a working knowledge of assigned projects- Act as back-up Safety Project Manager- Strive to meet financial objectives- Lead audits and resolve CAPAs- Implement standards for productivity, quality and customer service- Identify areas of improvement and escalates as appropriate- Delegate tasks and responsibilities - Prepare documents for submission to regulatory authorities- Ensure submission of regulatory documents are completed on time- Work closely with project team to coordinate project close-out- Participate in the process of developing and/or reviewing SOP’s- Train and mentor key GSPV project team members on project tasks- Mentor less experienced staff in project management tasks Show less - Process adverse events reports received from sites/reporters- Perform QC review of completed individual and periodic safety reports- Complete data entry including writing of adverse event narrative - Generate adverse event queries, liaise with the medical reviewers/client - Engage with the Site Monitors to ensure follow up information is obtained from site - Foster professional working relationships with all project team members- File documents according to project specific requirements- Ensure case files are compliant with Standard Operating Procedures- Distribute safety data reports to other Senior Safety Associate peer and Medical Monitor for review- Distribute safety data reports to clients and other relevant parties- Responsible for ensuring project deliverables are completed on time and with high quality- Ensure compliance with company policies, procedures and standards- Participate in the development of safety Standard Operating Procedures and Operating Guides- Participate in project meetings- Participate in audit as required - Assist with preparation/compilation and review of safety aggregated reports- Mentor and train other associates on processes regarding case processing Show less Most of my responsibilities are similar to the previous position but I have gained valuable experience by taking the lead responsibilities for various projects, being closely involved in regular e-mail and telephone contact with clients and representation of Global Safety and Pharmacovigilance group at investigator’s meetings. I have set up several projects together with safety plans, guidelines and I’m leading complex SAE reconciliation activities. I’m heavily involved in expediting process of regulatory submissions, DSURs, periodic listings including several years of experience with EudraVigilance. My current role also involves training and mentoring of employees. Show less

  • GSPV Project Lead

    Jan 2017 - Jan 2018

  • Senior Safety Associate

    Apr 2014 - Dec 2016

  • Safety Associate II

    Sept 2013 - Apr 2014

  • Safety Associate II

    Aug 2010 - Aug 2013
• 

  Syneos Health Clinical Solutions

  Jan 2018 - Feb 2020

  - Collaborate with Sponsors and major functional area leads - Ensure all project deliverables meet the internal and external customers’ expectations - Develop and maintain relationships with Sponsors in alignment with their assigned projects- Ensure that individual project targets and client needs are met with the highest quality standards- Provide oversight of all project SPVG deliverables - Assume accountability on SPVG deliverables including Start-up safety activities such as Kick-Off Meeting and Quick Start Camp- Day to day operational management and execution of all project deliverables- Responsible for ensuring that SPVG services are within scope of work and escalating/raising Change Orders when necessary- Develop plans in accordance with Standard Operating Procedures and/or client-scoped process- Review the project SPVG budget with the functional leads to ensure project profitability and take corrective measures where necessary to keep project in line with budget - Participate in audits/inspections and corrective/preventative actions- Ensure all relevant documents are submitted to the Trial Master File - Train/mentor key project team members on project/program specific tasks Show less - Collaborate with Sponsors and internal colleagues for multiple projects- Participate as the GSPV project lead in project launch through attendance of meetings - Develop detailed project specific Safety Monitoring Plans - Attend/present at Investigator meetings where applicable- Develop and maintain a working knowledge of assigned projects- Act as back-up Safety Project Manager- Strive to meet financial objectives- Lead audits and resolve CAPAs- Implements standards for production, productivity, quality and customer service- Identify areas of improvement and escalates as appropriate- Delegate tasks and responsibilities - Participate in the preparation of documents for submission to regulatory authorities- Ensure submission of regulatory documents are completed on time- Work closely with project team to coordinate project close-out- Participate in the process of developing and/or reviewing SOP’s- Liaise with GSPV Management providing project status updates, needs or obstacles- Drive projects with innovative ideas and recommendations and drives other to innovate- Train/mentor key GSPV project team members on project specific tasks- Mentor less experienced staff in project management tasks Show less Syneos Health™ is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together approximately 24,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customer's delivery of important therapies to patients. in short, we are shortening the distance from lab to life™. Show less

  • Safety & Pharmacovigilance Program Delivery Lead

    Jun 2019 - Feb 2020

  • Senior GSPV Project Lead

    Apr 2019 - May 2019

  • GSPV Project Lead

    Jan 2018 - Mar 2019
• 

  Arriello

  Jun 2021 - now

  - Oversee Global Drug Safety Managers and internal Global Drug Safety staff - Responsible for projects to ensure technical delivery, high quality deliverables and unit efficiency- Ensure appropriate resource management and task allocation- Development and implementation of Key Unit KPIs- Support team members with technical knowledge, management support and business discussions - Support operational team by ensuring staff development - Participate in scoping calls with new and existing clients - Design solutions to meet client’s expectation, developments and future prospects- Present the organization and its services at conferences and online events- Act as a partner for clients supporting their needs for current and future work- Involvement in development of Global Drug Safety quality management system - Ensure timely reporting of departmental data to support planning and forecasting- Involvement in company marketing activities Show less - Line management including team development and resource allocation- Mentor, coach and conduct regular performance appraisals - Oversight, management and support with clinical trials activities- Delivery of projects and tasks in line with client needs and agreements - Maintain project and capacity trackers, utilization and monthly summaries - Input and revision of clinical safety documentation- Reconciliation of SAEs and SUSARs- Preparation and oversight of aggregate reports- Evaluate and maintain local country reporting requirements - Support with proposals and incoming Clinical Safety opportunities - Participate in kick-off meetings and other project-initiation meetings- provide trainings on technical areas in scope- Consideration of client and internal feedback to improve quality of work - Properly escalate all unresolved issues or identified improvements - Manage and build working relationships with all stakeholders- Ensure full compliance with the processes and project deliverables - Involvement in inspections, audits and management of CAPAs - Participate in company marketing and promotional activities Show less - Manage Clinical Safety projects, in cooperation with the Project Manager- Act as the project primary contact point for project and technical matters - Perform risk management to identify and mitigate any potential risks- Create and review Safety Management Plans and associated forms - Ensure the delivery of projects/tasks per the client needs and agreements - Act as Responsible Person or deputy for EudraVigilance - Input and revision of other Clinical Safety documentation- Improvement of Clinical Safety processes- Oversight of the project specific safety database set-up and maintenance - Technical deliverables performed per the contractual agreements - Organize documentation per the company’s QMS- Cross-functional coordination across internal and external stakeholders - Trainings for Clients and external local partners - Trainings for project team members, departments and junior colleagues - Metrics and status reports - Participation in audits and inspections including preparation - Oversight of open Corrective Action Preventive Action (CAPA)- Sharing best practices and identify gaps Show less

  • Senior Global Drug Safety Manager

    Apr 2024 - now

  • Global Drug Safety Manager / Project Manager

    Dec 2023 - Mar 2024

  • Clinical Safety Team Lead

    Oct 2022 - Dec 2023

  • Clinical Safety Lead

    Jun 2021 - Sept 2022