Carli Sager

CARLI SAGER Date of Birth 15 May 1982 Address 009Northdowns 12 Mansion Str Glenhazel, 2192 Phone- E-mail- SUMMARY Efficient Clinical Trial Specialist with extensive experience with research ethics committees both in the UK and South Africa. Broad background in clinical trials phases II/III in various indications. Experience in Regulatory Authority (MCC) submissions. PUBLICATIONS Jonathan C Ipser, Don Wilson, Taiwo Akindipe, Carli Sager, Dan Stein. (2015). Pharmacotherapy for anxiety and comorbid alcohol use disorders. Cochrane Database of Systematic Reviews. EDUCATION & TRAINING 2011 MASTERS IN BIOETHICS & HEALTH LAW UNIVERSITY OF WITWATERSRAND incomplete 2005 PGCEUNIVERSITY OF CAPE TOWN - BACHELOR OF SOCIAL SCIENCEUNIVERSITY OF CAPE TOWN (Double Major) Psychology and Jewish Civilisation Dean’s List, 2004 2008 CLINICAL RESEARCH ETHICS TRAINING IMPERIAL COLLEGE LONDON 2009 ICH-GCP NRES LONDON, UNITED KINGDOM 2010 SA-GCP UNIVERSITY OF STELLENBOSCH 2013 ICH-GCP CLINTEC INTERNATIONAL 2013 SA-GCP WITS HEALTH CONSORTIUM, SOUTH AFRICA 2013 ICH-GCP NRES LONDON, UNITED KINGDOM 2014 ICH-GCP PAREXEL INTERNATIONAL, SOUTH AFRICA 2016 GCP PPD, SOUTH AFRICA -) Country Approval Specialist PPD International Prepare, review and coordinate, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy Provide, local regulatory strategy advice (MoH &/or EC) to internal clients, Provide project specific local SIA services and coordination of these projects Have contact with investigators for submission related activities Key-contact at country level for either Ethical or Regulatory submission-related activities Coordinates, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation Achieves target cycle times for site Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable Develop country specific Patient Information Sheet/Informed Consent form documents Assist with grant budgets(s) and payment schedules negotiations with sites. Support the coordination of feasibility activities, as required, in accordance with agreed timelines Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner Ensure the local country study files and filing processes are prepared, set up and maintained as per WPDs or applicable SOPs Maintain knowledge of and understand SOPs, directives, and current regulatory guidelines as applicable to services provided ICF Translation CTMS EMPLOYMENT (2014 – 2016) FREELANCER Locum Teacher : Business Studies Hirsch Lyons Boys Yeshivah Maharsha Boys (2013 – 2014) CLINICAL TRIAL SPECIALIST II (START-UP) PAREXEL INTERNATIONAL UK Assisted with Annual Progress Reports South Africa Conduct and facilitate specific start-up activities Prepare and submit MoH/RA documentation and follow-up until final approval received (Initial submission/Amendments), where applicable in countries fulfilling responsibilities of regulatory services. Prepare and submit IRB/EC application until final approval received (initial submission /Amendments). Preparation and negotiation of clinical site agreements (CSAs) at a site level ICF Customisation ICF Translation Site Regulatory Package or Green Light Package collation and Review Document tracking and loading in eTMF (2012 – 2013) CTC - REGULATORYCLINTEC CONTRACTED TO MSD Submissions to RA and Ethics Committees Updating and maintaining regulatory Files All in house activities and local process required for MCC and Ethics committees Responsible for in-house activities and local processes required to initiate, maintain and close out a study within a country. Spectrum LRA/steward Financial agreements steward eTMF Multiple Confidentiality Agreement Steward Steward for Informed consent translation process. (2012) FREELANCER Locum Teacher : Business Studies King David High School (2011 – 2012) INSTRUCTIONAL DESIGNERKALLEO PEOPLE GROUP Instructional Design Storyboarding Training (2010 – 2011) Research Ethics CoordinatorStellenbosch University Responsible for all student ethics submissions from pre-submission to ethics approval Responsible for student research ethics training and lecturing Training (2009 – 2010) TEMPORARY EMPLOYMENTVARIOUS Research administration IT administration (2007 – 2009) RESEARCH ETHICS COORDINATOR NATIONAL RESEARCH ETHICS SERVICE LONDON, UNITED KINGDOM Review of IRAS applications to ensure compliance to guidelines Responsible for all ethics submissions from pre-submission to ethics approval Responsible for administration of ethics committees Responsible for ensuring committee member adherence to all guidelines and changes to guidelines or processes (2006 – 2007) HEAD OF DEPARTMENTHERZLIA SCHOOLS Head of Travel and Tourism Business Studies Teacher Jewish Studies Teacher SKILLS WORK RA SUBMISSIONS ETHICS SUBMISSIONS CLINICAL RESEARCH TMF GCP  TRAINING PERSONAL COMMUNICATION ORGANIZATION PROBLEM SOLVING METHODICAL KNOWLEDGE TEAM PLAYER