Manager Assistant

SUMMARY

An experienced Sr. Site Start-Up Associate with considerable Local, US, and Global experience within the CRO, Pharmaceutical, Medical Devices, and Quality Assurance.

EXPERIENCE Date: From October, 2017 to Present Company Name: Premier Research Job title: Sr. Site Start-Up Associate

x Takes responsibility for quality deliverables at the country level for site start-up in one or more components

x Follows project requirements and applicable country rules

x Proactively forecasts submission/approval timelines and ensures they are adhered to. If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified

x Local Clinical Trial Applications Specialist - may serve as the primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects.

x Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules. May provide regular updates of country specific information on the clinical trial application database on SharePoint. Submits end of study notifications to Regulatory Authorities, Ethics Committees/Review Boards and other local authorities in the specified country according to national timelines.

x Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.

x Local Investigator Contract and budget negotiator - produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.

x Ensures accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF.

x Provides all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up

x Collects information on submission deadlines and timeline metrics for Regulatory Authority,

Ethics Committees, Investigational Review Boards and other local bodies as appropriate x Liaises with internal team members to review areas that impact study start-up and shares start- up information with the project team.

x Provides country-level intelligence on site start-up. Ensures that local country regulatory intelligence is maintained on the central repository, e.g. Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/ export license applications where these are obtained with RA applications.

x Sets up and maintains a country folder with country Ethics Committees/Review Board and local authority addresses and requirements.

x Pending country in use, the SSUA may set up and maintain details of existing site and institution contract requirements, as well as the necessary templates and fees, on the clinical trial application database on SharePoint.

x Provides quality review of the informed consent and adapts the template as appropriate.

x Works within the scope of Clinical Management Plan (CMP), study processes, ICH-GCP and/or requirements mandated by the study.

x Ensures documentation of QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client.

x May support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.

x Provides training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.

x Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.

x Mentors and trains junior level staff. x Leads larger programs through start-up x Excellent team player, collaborative and able to build an effective team x Ability to multitask and work effectively in a fast-paced environment with changing priorities x Strong verbal and written communication and negotiation skills x Excellent organizational and time-management skills, able to prioritize work to meet deadlines x Accountable, dependable and strong commitment x Is customer-service focused in approach to work, both internally and externally x Maintains a positive, results orientated work environment

Date: From April, 2014 to February 2017 Company Name: PPD, Inc.

Job title: Senior CAS (Country Approval Specialist)

x Prepare, review, and coordinate local regulatory submissions.

x Develops and implements local submission strategy and provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.

x Will be primary contact for investigators and for the local regulatory to ensure submissions are managed in a timely manner.

x Act as a key-contact at country level for all submission-related activities and participate as required in Submission Team Meetings, Review Meetings and Project Team meetings.

x Ensures alignment of submission process for sites and study are aligned to the critical path for site activation.

x Prepare the regulatory compliance review packages, as applicable, as well as liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.

x In addition, develop the country and sites specific Patient Information Sheet/Informed Consent form documents.

x Run Preclarus Reports weekly to determine the status of sites. Sites must be at 100% for SIP application. (Site Interest Plan). Must have 100% for SAP applications (Site Activation Plan) before Site Activation can occur.

x 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

x Achieves PPD's target cycle times for site. Per PPD SOP’s Target Activation Dates must be entered within 21 days.

x May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable

x Support the coordination of feasibility activities, as required, in accordance with agreed timelines

x Enter and maintain trial status information relating to Site Intelligence and Activation (SIA) activities onto PPD tracking databases in an accurate and timely manner

Date: From October, 2007 to February 2014 Company Name: Quintiles Job title: Regulatory Site Start-Up Specialist

x Prepare, review, and coordinate local regulatory submissions.

x Primary contact for investigators/site SC’s to ensure submissions are managed in a timely manner

x Maintain and manage SSU data tracking entries in database (CTMS/CI).

x Resolve site issues and report site status to SSU Team Lead.

x Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings x 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

x Maintain knowledge of and understand Client SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

x Work with regulatory team members and sponsor to secure authorization of regulatory documents

x Work with Clinical Operations, Project Management and Site Identification on SSU project specific status.

x Inform team members of completion of regulatory and contractual documents for individual sites.

x Knowledge and ability to apply GCP regulatory guidelines

x Strong knowledge of Microsoft Office/Outlook and E-mail application

Date: From August, 1994 to October 2007 Company Name: Catalent Pharma Job title: QA Auditor

x Conduct audits to ensure compliance with cGMP, DBA, FDA and Corporate SOP

x Audit executed batch records for compliance with cGMP. Perform laboratory audits announced and unannounced

x Review production and facility investigations and problem reports (Deviations, Corrective Active Plans).

x Participate in scheduling of internal audit program and issue results to manager and ensures issues are reviewed and corrective action plan is implemented

x Assistant in external audits

x Provide QA support to Manufacturing for clinical and commercial batches

x Assures standard operating procedures (SOPs) define the steps necessary to complete task, writes, and reviews and updates documents in Trackwise

x Analyze data trend

Job title: Analytical Chemist Inhalation x Designed data review team for Inhalation department

x Conduct analysis in support of QC Release, Stability and in-process Validation, Monitor and track projects for time line and quality assurance compliance

x Perform analysis for analytical samples in accordance with defined analytical methods and Standard Operating Procedures and within time lines as agreed with line management.

(HPLC/GC/Dissolution/Cascade Impaction) x Review and report data for QC Release, Stability and In-Process Validation

THERAPEUTIC EXPERIENCE

Skin disorders, Ovarian Cancer, Pancreatic Cancer, Nervous System/Sense Organs, Gastrointestinal,

FAOD (Fatty Acid Oxidation Disorder), Vitiligo, Pediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases and Congenital hyperinsulinism (CHI)

EDUCATION

Year: 1991 AAS, Industrial Pharmaceutical; Year: 1996, BA Psychology

Contact this candidate