Hedy Bernstein, M.A

Bedminster, New Jersey. *****

Accomplishments:

●Managing Study Budgets: matched accruals within 2% of the actuals on a quarterly basis for several years- per company policy.

●Project milestones were met or exceeded including first patient in (FPI)

●Recouped thousands of dollars from vendor due to incorrect management of returned drug supplies.

Professional Experience:

Mar 2017- Jun 2017

Senior Study Manager - Phase IV - Observational Study; Virology

Pfizer (short-term contract)

CRO and Vendor Oversight

Assist in the evaluation and analysis of clinical trial data to facilitate completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions

Assist in tracking study specific payments

Provide operational or work flow support to assure that departmental and cross functional systems and procedures were efficiently and correctly completed

Collaborate on project teams, primarily with the Clinic, Research and Development, Advanced Development, Marketing, Regulatory and Quality/Compliance

Lead or collaborate on technical writing projects including white papers, abstracts, manuscripts, and literature reviews

Clinical Project Manager - Phase III; Alzheimer’s Disease, Immunology. Jan 2015- Feb 2017

QuintilesIMS (contract)

●Manage Study Budget, protocol and timelines

●Collaborate with internal team members (Clinical Trial Coordinators and Regional Monitors) and external trial staff (Principal Investigators and Study Coordinators) to ensure study deliverables (FPI, FPFV, LPFV, LPLV, Database Lock) were on-track to achieve agreed-upon protocol timelines:

●Prepare clinical trial documents by creating, revising, and ensure documents are translated as needed (eg. consent form, diary cards, dispensing instructions etc.) adhere to local guidelines ensuring approval from Health Canada and ethics committees.

●Develop clinical trial budgets, negotiate contract payment terms and analyze the remaining budget on a quarterly basis ensuring achievement of overall study budget.

●Manage and maintained key trial metrics in IMPACT (Clinical Trial Management System) on a monthly basis by entering data into the system to achieve monthly quality index.

●Review monitor reports: adhere to local guideline and provide feedback to CRA to ensure adequate and accurate documentation of activities and issues are identified during monitor visits.

Expert Clinical Manager - Phase III; Respiratory. May 2013 - Dec 2013

Novartis (contract)

●Responsible for all operational aspects of 1 or more clinical trial(s) (phase II through lifecycle management) under the leadership of Global Trial Leader (GTL).

●Support program level activities of clinical trial(s) under the direction of the Clinical Scientist (CS).

●Support GTL in ensuring all operational trial deliverables are met according to timelines, budget, procedures and quality standards, development of study tools, guidelines and training materials;

●Management of clinical study material, implementation of issue resolution plan.

●Prepare clinical outsourcing specifications and manage vendors in collaboration with GTL.

●Contribute to the development, management and tracking of trial budget working closely with the GTL.

●In collaboration with Clinical Scientist (CS)/ Medical Lead, prepare training materials and presentations related to the planning and conduct of the trial.

●Support GTL in the management of the trial master file.

●Support GTL in managing interactions with the clinical trial team and CPOs.

●Support GTL in management of trial allocation and coordination of activities leading to site initiation.

●Support Medical Lead/CS/GTL by generating data cleaning reports and reviewing non-medical data as assigned.

●Support the GTL in trial close out activities.

●Write clinical trial team meeting minutes. Could deputize for the GTL at Clinical Trial Team meetings.

●May organize and chair trial sub-teams within the scope of his/her delegated responsibilities.

●Support program level activities. (i.e., DSUR, PSUR, IND updates, coordination of advisory boards), and support the implementation and management of trial monitoring boards (i.e., adjudication committees and Data Monitor Committees) as assigned.

●Responsible for implementation of best practices within Global Clinical Operations.

Senior Clinical Study Manager- Phase III; GI (cystic fibrosis) Apr 2012 – Dec 2012

Aptalis (contract)

Responsible for the overall performance of all the aspects of Clinical Study Management. This includes process compliance, appropriate resourcing with respect to budget, timeline and scientific requirements.

Organize and lead study planning, conduct and report of assigned studies as per planned timelines and budget.

Initiate and supervise outsourcing of clinical study tasks in line with the company strategy.

Train the clinical study team on scientific and technical aspects of the study.

Ensure occurrence of regular clinical study team meetings and ensure appropriate documentation of such.

Participate in investigator site recruitment and perform final site selection.

Review and approve case report forms and other study-related documentation (including consent forms, translations, material intended for patients, medication labeling, monitor plan, data management plan).

Maintain contact with investigators, site research staff and CROs personnel.

Ensure availability of study medication(s) and other study supplies

Track and report study progress.

Communicate in effective and timely manner regarding identified issues to study team and functional heads.

Ensure subject safety oversight as per approved policies and procedures

Review laboratory results and other relevant safety data of subjects taking part of the study, in collaboration with medical monitor.

Review adverse events and serious adverse events reporting in collaboration with pharmacovigilance and medical monitor.

Review and capture all protocol deviations.

Ensure quality assurance conduct of assigned clinical study(ies)

Identify risks and success factors and escalate appropriately to Director Clinical Operations.

Review site inspection reports, respond to scientific observations and implement corrective actions as needed.

Perform co-monitor visits at sites presenting unresolved or persistent issues, as needed.

Ensure good data validation (data coding and listings), statistical analysis plan (SAP).

Ensure that all crucial stages of studies are conducted in compliance with Good Clinical Practices (GCPs), internal or external collaborators’ SOPs and all applicable regulatory requirements as appropriate.

Collect data required for study report.

Clinical Project Leader - Phase I, III; Cardiovascular, Metabolism Jun 2011 – Dec 2011

Sanofi- (contract)

●Provide clinical research expertise in the development and conduct of day-to-day activities through all phases of a clinical trial (start up, recruitment and enrollment, data management, close out and archiving). Liaison between Corporate Clinical Development and the US clinical operations group in support of a clinical trial.

●Assist in planning, managing, implementation and reporting of clinical trials. Oversee preparation and implementation of project specific training programs and training materials for internal staff.

●Oversee monitor of patient safety, study eligibility, enrollment and data consistency.

●Ensure all relevant studies follow standard operation procedures and good clinical practices.

●Interface with project team as needed.

Conduct clinical team meetings, vendor and CRO meetings as needed.

Review protocol, ICF and CRFs for corporate team, perform feasibilities for US studies.

Responsible for initial study specific team training, then oversee continuation by lead CRA.

Oversee and assist in the develop study specific site tools and instructional manuals for sites.

Oversee “startup team” to assure all regulatory documents are in house in accordance with Sanofi SOPs.

Oversee drug distribution to sites in accordance with Sanofi SOPs.

Oversee and assist in the development of the Investigator Meeting and lead the meeting, providing presentations as needed in accordance with Sanofi SOPs.

Responsible for developing the study budget (AED) and negotiating the study budgets with the sites.

Responsible for sign off of study contracts (and contract amendments) with the sites, involving Sanofi legal when indicated.

Responsible for choosing the central IRB, provide submission for initial IRB approval of protocol, ICF and review of Investigator Brochure.

Responsible for advertising budget and approval of advertising literature.

Responsible for decisions to add sites or drop sites to meet timelines or assure compliance of the protocol.

Responsible for formation of “study closeout” team for Sanofi US CRU (Clinical Research Unit) to standardize processes.

Oversee and/or review of monitor reports from regional CRAs and performance reviews every six months.

Responsible for meeting timelines or guiding the protocol committee to logistics of “amendment” to assure timelines arelines or guiding the protocol committee to logistics of “amendment” to assure timelines are met.

Clinical Study Manager - Phase II and III; Women’s Healthcare Aug 2008 - May 2011

Bayer Corporation

Manage Phase II-III global clinical trials conducted to ensure they are within GCP, Bayer global and local SOPs, Code of Federal Regulations and local and central IRBs including:

Trial set-up and execution, budget management, patient recruitment/retention, database closure oversight, clinical supplies management, etc.

Monitor patients at the global level.

Ensure timely and accurate documentation and communication of study progress and issues, as well as ensure reports are generated within organization guidelines.

Comply with US and global regulatory agency regulations and guidelines as well as internal operating procedures and processes.

Participate in preparation for and conduct FDA and internal QA inspections and audits.

Determine team requirements, timelines and therapeutic area knowledge necessary to execute protocol.

Conduct study team, CRA, vendor and CRO meetings.

Manage study team: study data manager, study data programmer, study statistician, study medical expert

Manage team of 7 CRAs assigned to the trial.

Manage clinical trial assistants, Managed CROs and vendors.

Manage country level budget for the US.

Author Monitor Guidelines and Clinical Trial Plan.

Fulfill responsibilities per global and local SOPs, and Code of Federal Regulations.

Oversee investigator feasibility for US participation.

Conduct feasibility assessments and identify investigators for participation in studies and as back-up sites.

Provide input into protocol design.

Develop country timelines.

Develop payment schedule template for US.

Organize and lead the Investigator Meeting.

Oversee kick-off meetings with vendors.

Oversee study budget and contracts to ensure trial execution is within country budget.

Coordinate distribution and collection of study start-up documentation.

Closely track recruitment and discontinuation rates.

Closely track data collection and query resolution.

Trial Manager- Phase III CNS (psychiatry) Oct 2007 – Jun 2008

Johnson & Johnson, Pharmaceutical Research and Development (contract)

Manage all logistics and conduct of the clinical trial.

Coordinate team personnel for successful clinical trials.

Approve contracts and budgets.

Track study budget and time lines.

Clinical Study Manager- Phase III; Pain Management Apr 2007 – Sep 2007

Gruenthal USA (contract)

Manage Phase III clinical global trials conducted by academic and healthcare institutions within quality guidelines, timelines and budget.

Manage execution of IND and sNDA submissions.

Trial set-up and execution, budget management, patient recruitment/retention, database closure oversight.

Manage in-house CRAs, CRO and vendors.

Ensure required reports are generated within organization guidelines.

Ensure compliance with US and global regulatory agency regulations and guidelines and internal operating procedures and processes.

Participate in preparation for, and conduct of, FDA and internal QA inspections and audits as needed.

Contribute to draft of protocols, amendments, clinical trial reports, clinical trial plans and monitor guidelines.

Relationship management between study sites and vendors, supervision of study related activities, identification of project risks and contingency planning.

Oversee trial timelines are met and resources are available.

Oversee budgets and contracts to ensure trial execution is within approved country budget.

Conduct resource forecasting and allocation.

Obtain internal agreement of outsourced work.

Ensure adequate and timely performance by CRO/vendor.

Assist with contract negotiation of investigational sites and central laboratory.

Clinical Research Associate - Phase II and III; Metabolism, Urology Aug 2005 – Nov 2006

GlaxoSmithKline, Inc. (contract)

●Monitor clinical sites of assigned trials in compliance with FDA regulations, ICH/GCP guidelines and GSK SOPs.

●Screen and recommend Principal Investigators, attend study Investigator Meetings.

Conduct site initiations, perform interim monitor visits, study closeout visits of 22 sites across 2 therapeutic areas.

Support study management project teams in the placement, implementation, evaluation and conclusion of clinical studies as stipulated in the protocol and monitor plans.

Scientific Editor Jun 2004 – Mar 2005

BioSpace, Inc. (Contract)

Provide medical writing input for clinical development features of newsletter.

Evaluate and interpret scientific, clinical and statistical data of featured trials.

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Medical Research Associate - Phase II and III; Virology, Immunology and Neurology Jan 2001 – May 2004

Boehringer Ingelheim Pharmaceuticals, Inc

Project Management of Tipranavir (non-peptide protease inhibitor) in Phase II and Phase III trials.

Manage contract MRAs, vendors and CROs

Review and approve statements of work and work orders from vendors.

Manage IND, Phase II meeting with FDA of NDA submission.

Develop trial budgets, provide budget forecasts, enrollment projections and timelines.

Co-author protocols, amendments, clinical trial reports, IND annual safety reports (clinical section).

Produce clinical trial plans and monitor guidelines.

Coordinate the updating of the Investigator Brochures.

Review and approve all monitor trip reports.

Oversee and track all study SAEs, reporting to safety group and ensure reconciliation.

Review safety data sets and listings.

Perform medical coding using MedDRA, WHO-ART, WHO-MED.

Participate in CRF development.

Develop the study Investigational Site File.

Perform a QA of regulatory documentation.

Coordinate the collection and review of all study data.

Construct study Informed Consent Form.

Organize and present at Investigator’s Meetings.

Maintain and update data in CTMF and CTMS.

Collaborate with development of study mini Mental Status Evaluations and modified psychotic questionnaires for grading Psychosis in Parkinson’s patients in conjunction with the Therapeutic Director.

Skills:

Documentum, Oracle/Clinical (read only access), IDEA, Clinical Trial Master Systems, Clinical Trial Master File.

ClinTrial, QueryMan, PANSS Training and Certifications, Neurocognitive Test Battery, Calgary Depression Scale.

MedDRA, WHO-ART, WHO-MED medical coding, InForm (eCRF) version 4.5, SiteLinks

Therapeutic Areas:

Virology, Cardiology, Respiratory,Metabolism (Diabetes), CNS (psychiatry, neurology), Immunology, Women’s Health Care, Pain Management and Urology,

Education:

●Ph.D: Completed all course-work and dissertation research from the Graduate School of CUNY

Master of Arts Degree from New York University - New York, NY

Bachelor of Arts (Cum Laude) Honor’s Scholar Program from New York University - New York, NY

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