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Alisa Dungy Rahilly

Associate Clinical Trial Manager

Sr. Mgr., Clinical Operations at Fulcrum Therapeutics

Greater Boston Area

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Alisa Dungy Rahilly's Email Addresses & Phone Numbers

Alisa Dungy Rahilly's Work Experience

Biogen Idec

Associate Clinical Trial Manager

August 2008 to August 2011

Cambridge MA

Biogen Idec

Sr. Clinical Trial Coordinator

June 2007 to August 2008

Cambridge MA

Fulcrum Therapeutics

Sr. Mgr., Clinical Operations

Cambridge, MA

Alisa Dungy Rahilly's Education

Central Missouri State University

Bachelor of Science

1997 to 2001

University of Hawaii at Manoa

2000 to 2000

Alisa Dungy Rahilly's Professional Skills Radar Chart

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Verbal
Impulsive
Innovative

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Alisa Dungy Rahilly's Estimated Salary Range

About Alisa Dungy Rahilly's Current Company

Biogen Idec

Frequently Asked Questions about Alisa Dungy Rahilly

What company does Alisa Dungy Rahilly work for?

Alisa Dungy Rahilly works for Biogen Idec


What is Alisa Dungy Rahilly's role at Biogen Idec?

Alisa Dungy Rahilly is Associate Clinical Trial Manager


What is Alisa Dungy Rahilly's personal email address?

Alisa Dungy Rahilly's personal email addresses are and a****[email protected] and a****[email protected]


What is Alisa Dungy Rahilly's business email address?

Alisa Dungy Rahilly's business email addresses are not available


What is Alisa Dungy Rahilly's Phone Number?

Alisa Dungy Rahilly's phone (**) *** *** 229


What industry does Alisa Dungy Rahilly work in?

Alisa Dungy Rahilly works in the Biotechnology industry.


Who are Alisa Dungy Rahilly's colleagues?

Alisa Dungy Rahilly's colleagues are Bryan Morris, John Harmon, PMP, Denise Saban, Michelle Madden, Andrea Calenne, Katharina Gasser, Steve Van Nuffel, Kit Rohde Laursen, John Keane, and Caroline M. Puetz


About Alisa Dungy Rahilly

📖 Summary

Associate Clinical Trial Manager @ Biogen Idec From August 2008 to August 2011 (3 years 1 month) Cambridge MASr. Clinical Trial Coordinator @ Biogen Idec From June 2007 to August 2008 (1 year 3 months) Cambridge MASr. Mgr., Clinical Operations @ Fulcrum Therapeutics Responsible for clinical operations strategy and execution. Cambridge, MAClinical Operations Lead @ Biogen Idec • Accountable for overall study success• Manage multi-national clinical studies as the Global Lead within neurology and immunology therapeutic areas• Execute clinical studies by strategic oversight of the CRO and all additional vendors from start-up, maintenance, and Lock with rigorous regard for ICH/GCP, timelines and budget• Direct site feasibility activities utilizing both internal country affiliates and external vendor partners • Develop and oversee the assessment of country-level operational feasibility culminating in a recommendation to the Clinical Development Team (CDT)• Plan and present at Investigator Meetings• Track and present study progress metrics to Senior Management as well as manage overall study budget• Lead the Study Management Team (SMT), a cross-functional group with representatives from all key internal departments, to execute a study from protocol concept to final clinical study report• Lead protocol development from concept to finalization within the scope of the Clinical Development Plan (CDP), program budget, and both corporate and regulatory timelines• Design internal study-specific Operations Plans which describes deliverables, risk mitigation strategies, escalation pathways, communication plans, quality metrics, and timelines• Serve on multiple process improvement initiatives across the department and act as a Subject Matter Expert (SME) for key clinical activities (such as study start-up) From April 2013 to March 2015 (2 years) Cambridge, MAClinical Trial Manager @ Biogen Idec •Manages all aspects of study including: assesses operation feasibility and recommends study execution plan, develops and manages comprehensive study timelines and metrics, participates in mgmt and selection of external vendors. •Provides study specific training and leadership to clinical staff, CRO’s, CRA’s, sites and other contract personnel, prepares and presents project debriefings, plans executes, and leads study specific meetings, participates in site monitoring visits as required.•Works with business analyst to develop and manage study budget and maintain within financial goals; reviews and approves clinical invoices against approved budget.•Works with study mgmt. team to design clinical trial protocol consistent with the clinical development plan; develop an ODMP to ensure proper patient recruitment, detection of data trends and to ensure study objectives are met, provides input for the design of the ICF, CRF’s, monitoring conventions, and edit checks etc.•Coaches and provides guidance to clinical trial coordinator’s. From August 2011 to April 2013 (1 year 9 months) Cambridge, MAClinical Research Associate II @ Point Therapeutics Monitored for biopharmaceutical company’s lead product candidate in two phase III oncology studies. •Responsible for the completion of site visits including, but not limited to, qualification/pre-study, interim, and close-out monitoring visits•Monitored source documents and Case Report Forms (CRFs) for each subject in accordance with ICH-GCP guidelines and Point Therapeutics' SOPs to assure timely, accurate, and quality data retrieval•Responsible for verifying sites' drug accountability and logs, ensuring sites had adequate drug supply, assisted in ordering additional drug for sites as necessary and completing drug destruction procedures at the sites• Assured that regulatory and all required documents were filed, completed and accurate and were in accordance with all ICH-GCP requirements at sites•Completed visit reports and follow up letters in the required timeframe, communicated expectations for the monitoring visits as well as the results with site personnel and the in-house project team•Site management; served as the primary contact for assigned clinical sites regarding study implementation, issues throughout the conduct of the study, enrollment questions, re-order of study supplies, etc.•Ensured that serious adverse events (SAEs) were reported accurately and in the required timeframe•Facilitated the resolution of queries From January 2006 to May 2007 (1 year 5 months) Boston, MAClinical Research Coordinator II @ Tufts-New England Medical Center •Knowledge of GCP’s/CFR/ICH guidelines•Responsible for submission of initial protocols, continuing reviews, and amendments for studies to IRB•Completion of serious adverse event reports to IRB•Collected study data/source documentation and complete paper and electronic CRFs•Maintained study specific regulatory documentation binders (financial disclosure’s, 1572’s, CTA’s, CV’s, correspondence, IRB approvals, etc)•Liaison between Principle Investigator, IRB, and sponsor companies•Responsible for composing/revising informed consent forms, research authorization forms, tissue banking consent forms•Assist in creation of study budgets with research administrator and sponsor companies•Creation/preparation of screening materials and assist in screening patients•Organized and conducted site initiation visits, monitoring visits, and close-out visits•Assisted in creation of CRFs for principle investigator-initiated study•Point of contact for principle investigator-initiated protocol for multi-site study•Patient point of contact for questions/problems concerning studies•Responsible for lab processing/shipments involved in studies•Participated in internal study audit with major pharmaceutical company From January 2004 to January 2006 (2 years 1 month) Boston, MAQC Analyst @ Therion Biologics •Knowledge/use of cGMP’s, GLP’s, and QC practices•Sample submission of in-process/final vial samples to contract test facilities and clinical sites•Liaison for contract test facilities/clinical sites regarding sample submissions and shipments•Development and revision of Standard Operating Procedures•Trained analysts on SOP’s and operating systems•Equipment validation including IQ/OQ reports•Total Protein/Purity’s, BSA ELISA, Western Blot, Titration assays•Microbiology assays including LAL, pH, Conductivity, Bioburden, Environmental/personnel monitoring of aseptic areas using RODACS, Sterility testing and qualification of materials•Implemented new system under supervision of V.P. OF QC/QA for systemizing all QC interim in-process/final vial testing data•Maintained and updated databases regarding stability program, testing schedule, assay results•Designated Liaison between Safety/Facilities Dept. and Quality Control for safety issues in QC lab From October 2001 to January 2004 (2 years 4 months) Cambridge, MA


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In a nutshell

Alisa Dungy Rahilly's Personality Type

Extraversion (E), Sensing (S), Thinking (T), Judging (J)

Average Tenure

1 year(s), 11 month(s)

Alisa Dungy Rahilly's Willingness to Change Jobs

Unlikely

Likely

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