Manager, Clinical Trial Agreements - Replimune - Woburn, MA
(2022-03 - 2026-06)
- Performed overall management associated with planning, negotiation, execution, tracking, and close out of all clinical trial agreements
- Oversaw US and International clinical trial agreements (CTAs) including development, negotiation, and approval of site budgets. Ex-US countries include Canada, Australia, UK, France, Germany, Poland
- Lead clinical site outreach for negotiation and execution of non-disclosure / confidentiality agreements (CDAs) to support CTA deadlines
- Developed, updated, and managed protocol driven CTA templates and country specific budgets
- Partnered with clinical sites and contract research organization (CRO) partners to negotiate and finalize CTA terms and budgets
- Reviewed CTA budgets to support fair market value (FMV) analysis plus development and reporting of CTA budget metrics.
- Prepared monthly report for upper management which includes pivot table of all fully executed CTA's and amendments for all studies and countries, Per Patient Budget and Site costs per site, and summary of number of patients enrolled and active per site across studies and countries
- Provided Clinical Operations study leads and team members with routine updates regarding the CDA / CTA status
- Collaborated in the review of study-related documents, including study protocols, informed consent documents
- Participated in meetings with clinical team in collaboration with investigative sites, key opinion leaders and consultants as needed
- Partnered with Replimune's Finance team for various CTA budget reporting activities on a monthly basis
Clinical Operations Finance Business Partner - Replimune - Woburn, MA
(2019-08 - 2022-03)
- Managed all clinical site contracts/budgets for monthly accrual and site invoice payment review. Prepared monthly journal entries for Investigator cost accrual for all US and EUR trials and sites. Prepared and updated monthly Investigator Accrual report which tracked site patient visit costs, site payments and enrollment numbers
- Reviewed and managed expenses for payment with all clinical sites, for all studies. Reviewed, reconciled and approved site invoices for patient visits and invoiceables and site costs
- Prepared/updated monthly finance report: Clinical Trial Detail Expense Analysis which tracked CRO/vendor payments by trial and by GL account number
- Prepared monthly Balance Sheet reconciliation for GL account 3200: Investigator accruals and payments
- Participated in audits
- Prepared monthly site patient visit statements to email to sites for invoice initiation
- For FP&A support, developed and tracked all trial timelines to budget and patient metrics from beginning to end. Maintained financial model for clinical trial budgeting and forecast for CRO and vendor related costs. Maintained financial model for site/Investigator Costs based on enrollment projections and site budgets. Tracked all payments for vendors and sites on financial model. Participated in preparation of new redesigned financial model for clinical trials
- Reviewed new site budgets and budget amendments for US and EUR. Prepared budget cost analyses for submission for approval.
- Prepared and updated budget cost tracker for all trials and sites
- Prepared, updated and reviewed site budgets and budget templates for Protocol updates
- Assisted in setting up requisitions for purchase orders on Prendio ensuring accurate GL accounts and project designation
Financial Analyst - Boston Medical Center - Clinical Trials Office - Boston, MA
(2018-10 - 2019-08)
- Performed financial management associated with pre-award and post-award: planning, negotiating, setting up, managing, and closing out clinical research studies
- Evaluated study protocols and developed accurate budgets
- Met with research study team and Principal Investigator to identify and quantify pertinent information impacting clinical trial finances, distinguish between billable (standard of care or SOC) and non-billable costs and ensured overall adherence to Federal compliance in the budgeting process
- Served as primary resource on the business and finance aspects of clinical research and maintained appropriate records and database.
- Worked with study teams to develop coverage analyses, clinical trials budget, and report to track and monitor receivable
- Created and analyzed clinical trial financial reports and ensured financial information had been recorded accurately. Communicated findings and made recommendations to Director and members of each study team as appropriate
- Performed financial forecasting and reconciliation of internal clinical trial accounts
CTO Trial Manager / Accountant - (Started as Consultant through Robert Half) - Dartmouth-Hitchcock Medical Center - Clinical Trials Office - Lebanon, NH
(2016-12 - 2018-09)
- Conducted and prepared financial summaries, budgets, and analyses for the Dartmouth Clinical Trials Office (CTO) to include all necessary tasks associated with post-award function of clinical trials including overall study management, patient bill review, study closeout, and the Institution's clinical trial implementation and continued support of PeopleSoft accounting modules
- Performed financial management and accounting activities for the Institution's clinical trials. In addition to financial tracking, assisted in the preparation of financial projections and retrospective analyses of the studies
- Assisted in the implementation and on-going management of PeopleSoft Project Costing and Contracts modules. This included automated expense approval & milestone allocation, account set-up, processing revenue transactions, tracking accrued expenses, and monitoring budget-to-actual comparisons. Worked with Corporate Accounting to ensure that these transactions are posted to the general ledger
- Upon IRB termination, ensured that all study revenue had been recognized and collected. Verified that all patient care invoices had been collected and paid. Performed a post-study revenue and expense analysis
Salaried Professional/Consultant - Members First Credit Union (Corporate Accounting/Finance Consultant) - Robert Half International - Manchester, NH
(2015-12 - 2017-11)
- Performed daily general ledger accounts settlement, reconciliations, and closing
- Prepared and submitted FR2900 report
- Prepared Month end reporting including budget accrual analyses, GL true up and reclass entries
- Researched and analyzed complex balancing routines
- Ensured complete accurate and timely delivery of all accounting department reporting requirements
- Performed month end reconciliation and analysis report, tied out all Balance Sheet accounts and recommended adjustments
- Prepared upper management reports: new deposit and new loan accounts, reconciliation of bank portfolio/investments
- Performed Monthly analysis, review and GL entry preparation for Participation loans
Salaried Professional/Consultant - St. Mary's Bank (System Implementation Accounting Consultant) - Robert Half International - Manchester, NH
(2015-12 - 2017-11)
- Reviewed Data integrity for system implementation
- Worked with banking technology, accounting team, and loan servicing on post- integration/implementation of new system Symatar /Episys
- Analyzed, reconciled, and created procedures for reconciling FICS Clearing account, FICS Disbursement, trial balance and BIGS balances, escrow account, loans held for sale, unapplied account, interest and accrual; streamlined processes and standardized procedures
- Acted as Back up for current staff during leave of absence, training of system during re-organization maintaining efficiency and ensuring accuracy
- Cleaned up work from system implementation, analyzing, reconciliations, updating of policy and procedures
Fund Treasury Supervisor (started as Fund Administrator- promoted to Supervisor in Feb 2010) - MFS Investments - Boston, MA
(2008-04 - 2013-12)
- Managed a Senior Fund Administrator and a Fund Administrator; prioritized and allocated work; provided guidance and technical assistance; made recommendations regarding performance measurement, training, development and other related personnel activities
- Maintained expertise in all matters with respect to assigned mutual funds within Fund Treasury. Using technical expertise and up-to-date knowledge of accounts, assisted others as required. Acted as a role model for the administrators
- Under the direction of Assistant Treasurer and Manager, helped to assure the goals and objectives of the unit were attained
- Reviewed reports and ensured the integrity of information prepared and issued by the team. Assisted in developing control and management reports for the unit
- Reviewed complex calculations of asset-based fees, expense caps, fund expense ratios, and expense budgets prepared by staff.
- Assisted in preparing procedures and job aids, reviewed quarterly to ensure that all procedures were documented and updated
