Experience

Miltenyi Biomedicine
• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Associate Director Clinical Operations

  • Sep 2022 - Present

H3 Biomedicine
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Senior Manager Clinical Operations

  • Apr 2019 - Sep 2022


BeiGene

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Study Manager

  • May 2017 - Apr 2019

  Phase III trial in oncology. Phase III trial in oncology.



Tesaro (Contracted by KPS Life)

• Clinical Consultant

  • Jun 2016 - Apr 2017

  Phase II & III trials in oncology. Phase II & III trials in oncology.



Biogen

• South Africa
• Wellness and Fitness Services
• 1 - 100 Employee

• Clinical Trial Coordinator

  • May 2015 - Jun 2016

  Therapeutic Areas • ALS – Phase 1 - Program and Study level • SMA – Phase II - Study level • Stroke – Phase II - Study level • Haemophilia – Phase I - Study level Vendor management • Review and approve patient recruitment materials • Oversee patient travel and ensure costs are within tolerance • Study specific questionnaires • Investigator Meeting preparation related to travel and accommodation as well as meeting agendas and supply management • Drug shipment and returns approval and issues management CRO Oversight • Coordinate CDA preparation, collection and execution; legal review form completion • Review and collection of financial disclosures • Study level milestone review • TMF audit preparedness Sponsor related responsibilities • Creation of study specific source documentation for site distribution • Creating, reviewing, approving, distributing and tracking Site Reference Materials • Budget review • Management of the clinical trial management system e.g. IMPACT • Transparency subject matter expert for the Sunshine Act and VCTR • Creating and maintaining VCTR, Biogen Idec’s CT.gov registry platform • Preparing and maintaining Insurance certificates • Participate in study design and execution by contributing operational experience and expertise; Provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications • Tracking protocol deviations • Populating, distributing, reviewing and tracking all essential documents throughout the study • Supporting audit/inspection readiness • Ad hoc tasks as assigned by management Show less



Shire Pharmaceuticals

• Clinical Transparency Development Coordinator

  • Oct 2014 - Apr 2015

  • Responsible for the Clinical Trial Transparency Planning and Activity Tracking function. • Serve as liaison to multiple functional areas, including key study personnel and system owners. • Utilize study attributes and study/product information to assess which transparency/disclosure requirements apply to each study/product. • Work with study teams to identify due dates, assign ownership of task, and track all activities. • Monitor source systems for data changes that impact plans, update plans/actuals accordingly, and communicate status changes. • Follow-up to confirm that activities are completed as required. • Develop and distribute reports to track compliance. • Point of contact for Aggregate Spend across all applicable studies. • 2014 Aggregate Spend reconciliation. • Created an in-depth User Guide detailing the Clinical Trial Transparency information/data requirements regarding where to locate, who to contact and where to input the information Show less



Premier Research

• United States
• Biotechnology Research
• 700 & Above Employee

• Lead Clinical Trial Associate

  • Aug 2013 - Oct 2014

  • Manage administrative support and tasks for the Clinical Project Team. • Maintains active study files and prepares key documents for files. • Attend project team meetings, prepare meeting agendas and minutes, and maintain action item lists from meetings. • Ensure TMFs comply with SOPs, GCPs and other regulations. • Collect and track regulatory documents for submission to Central and Local IRB and verify IRB approvals. • Maintain study enrollment logs and study status spreadsheets. • Distribute study materials to investigator sites. • Prepare documents and distribute various investigator, regulatory, operations, guidelines and training manuals. • Assist in preparation for investigator and project launch meetings. • Assist in preparation for and attend client meetings. • Support clinical monitoring staff for visit preparation regarding regulatory document tracking and other study file correspondences. • Act as contact for investigators and study site staff communicating project specific information to/from sites. • Support Project Manager/Clinical Manager by assessing project feasibility, undertaking site selection and recruitment. • Perform additional duties and assignments as requested. Boehringer and Ingelheim Project • Manage the eTMF for 24 trials consisting of national documentation and local documentation across hundreds of clinical sites. • Run reports for each clinical trial team on a bi-weekly or monthly basis. • Responsible for the training of two new Clinical Trial Associates. Show less



PriorIT

• IT Services and IT Consulting

• Website Consultant

  • Apr 2012 - Oct 2014

  • Help small and medium sized businesses create websites. • Set up client domain names. • Identify the needs of the client i.e. increase business revenue, advertising services, create web based portfolio for potential investors to review. • Identify competitor websites and use them as a tool for clients to pick and choose items that will bring the most value. • Create a detailed outline regarding the look and content of the client’s website and send off to the development team. • Present the pre-finalized website to the client and make any necessary changes. • Review the content language to ensure that are no grammatical errors. • Work with clients to establish web based advertising so their website will be represented in search results. • Provide clients with in-depth performance analysis using Google Analytics. • Generate new business through referrals. Show less



DePuy Spine

• Clinical Research Associate (Contract)

  • May 2011 - Mar 2012

  • Responsible for six study sites for the DISCOVER Trial. • Participated in the re-monitoring of all study sites monitored prior to 2008 for the DISCOVER Trial. • Successfully monitored device accountability records for all sites. • Performed site visits and ensured study sites were compliant with study protocol and all federal, state and local regulations. • Ensured the collection of high quality substantiated data. • Regularly contacted sites and responded to issues/problems and assisted in implementing corrective and preventative actions. • Worked with sites to remotely resolve any queries. • Completed the IMVR, AI list and FUL for all study visits. • Responsible for peer reviews of IMVRs, AI lists and FULs. • Served as liaison between clinical operations and study site personnel for the DISCOVER project. • Functioned as the reliable contact for up-to-date study information for my study sites. Show less



Thoratec

• Computer and Network Security
• 1 - 100 Employee

• CRAA

  • Jul 2010 - May 2011

  • Co-monitored at Brigham and Women's Hospital in April 2011. • Responsible for the in-house entry and maintenance of the in-house TMF for 13 study sites. • Completed a detailed QC of the in-house TMF’s. • Lead author in the creation of a workflow that detailed the QC process of Thoratec’s in-house TMF. • Co-author in the creation of a workflow that detailed the reimbursement of destination therapy study sites. • Created a workflow detailing the contract process between Thoratec and its study sites and vendors. • Successfully completed a source doc verification training exercise using a real patient’s de-identified chart and CRFs. • Regular email and occasional phone contact with study site personnel. • Training coordinator for Thoratec’s January 2011 new contractor training session. • Scribe for CRA and clinical department meeting minutes. Show less



Massachusetts General Hospital

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Operations Manager

  • Aug 2009 - Mar 2011

  • Managed roughly 200 administrative and environmental personnel throughout the hospital. • Mediated conflicts between staff. Responsible for creating verbal and written warnings or recommendations for termination.• Responsible for properly resourcing administrative and environmental personnel for each unit to ensure smooth daily operations.• Assisted in the organization and implementation of emergency planning

• Operations Associate

  • Feb 2008 - Aug 2009

  • Transcribed all medication, treatment and activity orders for the general medical care unit.• Maintenance of patient charts from admission to discharge.• Acted as a point of contact for the patients, nurses and doctors regarding all general information, new admission status, open bed status and potential problems.• Determined the best person to attend to a patient request (doctor, nurse, nursing assistant, etc) to ensure no particular group is unnecessarily over worked.d• Created a priority schedule to help manage my daily tasks which has resulted in better patient, family, nurse and doctor care from my end. Show less