Danielle Booth, Mba Email & Phone Number

New Jersey, United States

Bagsværd, Dk

· Management of clinical trial budget/contract negotiations in accordance with local regulations (US and Canada), full process of budget development, negotiation and execution· Lead on multiple process improvement initiatives with key internal and external stakeholders· Ability to manage individually or in conjunction with legal the execution of Appendices, Master Agreements, trial specific Clinical Trial Agreements, SOWs, Exhibits, and Contract Amendments· Contribution to risk management and feasibility in study start up through discussions with trial and feasibility teams· Ability to assess financial risks and provide mitigation/escalations to the appropriate stakeholders, as necessary· Project management from study start up to DBL· Interaction with site personnel - PI, study coordinators, contract administrators, budget teams, and site legal· Interaction with key stakeholders including NNI legal department, Finance managers, Trial Managers, and Senior leadership in execution of contracts and budgets· Ability to demonstrate analytical and critical thinking skills to resolve issues, streamline processes and increase workflow efficiencies· Review of clinical protocols to develop cost per patient budgets for North American Clinical Operations based on current Fair Market Value (FMV), US and Canada· Understanding of Investigator-initiated studies, and Real-world evidence/Pragmatic trials· Compilation of key study information for tracking and trending, including financial savings metrics and contract milestones· Utilization of the Medidata system, and other internal systems to track site information and key financial data points· Provide project direction to Senior Associates for assistance with contract and budgeting, as well as ancillary supplies· Participation in study team meetings· Compilation of statistical data and visuals as support for budget escalations and negotiations, and trial budget trends· Training and mentoring of new team members

Bagsværd, Dk

· Management of electronic Trial Master File (eTMF) for assigned trials, archive of required paper documents throughout the duration of the trial, including start up and closeout, and applying documents uploaded to eTOC· Update clinical trial management systems of relevant internal trial personnel, study site personnel, central and local IRB locations, and trial milestone dates· Tracking of clinical documents including deviations, trial product shipping documentation, and safety reports· Distribution and collection of protocol deviations at site and country level· Distribution of various study related materials to trial sites, including country level trial updates, manuals, protocols, protocol-related documents, and safety reports, as necessary· Compilation of Clinical Trial Report (CTR) documents including List of Investigators, Log of Financial Disclosures, and Log of Institutional Review Boards· Quality review of site level documents including 1572s, IRB documentation approvals/submissions, temperature logs, financial disclosures, licenses, CVs, etc., as well as follow up on outstanding documentation from sites· Experience in global clinical trials, managing both US and Canadian sites· Subject Matter Expert for Document Management and “Super User” for eTMF system

Raleigh, North Carolina, Us

· Data tracking and entry in study spreadsheets, and clinical data reconciliation for multiple trials· Assists Clinical Study Managers (CSMs) with drug reconciliation management· Assists Clinical Study managers (CSMs) as point person for patient transfers and clinical endpoint activities· Assists in resolving queries issued by data management· Assists with site close out activities· Provides support with trial budget and accounting, including invoice approval and financial contract amendments· Provides support to investigators and investigative site staff, acting as a liaison between study site and field monitors, in-house Novartis team members and the Global team for numerous study related issues· Tracks Monitoring Visit Reports and upkeep of reporting systems (TMF, STARS, CREDI, etc.)· Tracks trial enrollment and basic statistical analysis for currently enrolling trials· Attends and participates in local and global study team meetings

Basel, Baselstadt, Ch

Basel, Baselstadt, Ch

Data tracking and entry in study spreadsheets, and clinical data reconciliation for multiple trialsAssistance to Clinical Study Managers (CSMs) with ordering/tracking/mailing of trial supplies, coordination with vendors, and drug reconciliation managementProvide support with trial budget and accounting, including invoice approvalTracking and organizing regulatory documents for central and local IRBsTracking of Investigator Meeting attendance and upkeep of reporting systems

Annandale, New Jersey, Us

Responsible for spa operations and customer experience driving an increase in sales of spa products and services.

New York, New York, Us

Team member supporting a major pharmaceutical company program in national and global maternal health, focused on gathering research and reducing maternal mortality.

Edison, New Jersey, Us

Responsible for pharmacy counter management including sales and patron experience

Master Of Business Administration - Mba, Pharmaceutical And Healthcare Business

Bachelor Of Science (B.S.), Public Health

Education record