Manager Management

BETHANN E. SCHRADER-GIANCARLO

**** ****** **** **** ******, NY 14052 716-***-****

________________________________________

Seasoned Clinical Data Manager with experience in complex projects and in managing multiple large, international clinical trials for Phases I - IV to GCP/ICH standards in biotech, pharmaceutical and non-profit venues. Ability to work within a complicated matrix environment while also independently self disciplined. Possesses solid project management skills with the ability to anticipate problems relating to projects and to develop and implement solutions. Extensive experience working with remote teams and as a field-based employee. Adaptive and creative with demonstrated leadership, interpersonal, organizational, and analytical skills. Therapeutic areas include HIV (Gynecological, Pediatric and Perinatal), Oncology (Multiple Myeloma, Leukemia, GIST, Osteosarcoma, Prostate, Pancreatic and other Solid Tumor) and Devices.

EXPERIENCE:

Sr. Clinical Data Manager, Consultant, Feb 2008 – Jun 2012

Infinity Pharmaceuticals, Cambridge, MA- Remote from Buffalo, NY

EDC/Management Experience:

• Collaborated on the evaluation and implementation of updated technology for Data Management. Worked with EDC vendor to identify gaps in user workflow to create new EDC instance.

Oversaw the start-up of 4 new EDC trials and the update of 3 ongoing trials in short timeframes

Collaborated with Clinical staff and Clinical CRO staff members in the start-up, implementation and close out of numerous studies in diverse drug programs.

Rescue specialist for two studies in need of improvement in design and review.

Performed database build and maintenance tasks in Medidata RAVE®.

Data Management Lead/Medical Coding Experience:

Utilized MedDRA and WHODRL coding dictionaries to code clinical data.

Performed clinical data review for legacy studies to ready for database lock.

Reviewed protocols, developed project plans, designed case report forms (CRFs), authored CRF completion guidelines, data validation plans (DVPs) / edit checks, Quality Control Plans, Notes to File and other elements of the data management plan (DMP).

Collaborated with Pharmacovigilance specialists to perform SAE Reconciliation.

Developed/tested/approved edit check specifications and finalized output while ensuring consistency/continuity among protocol, CRF design, annotation and clinical database structures.

Reviewed and commented on operations documents (e.g., monitoring guidelines).

Presented at Investigator Meetings.

Performed all aspects of data review for trials and ensured data was acceptable for database lock.

Advised clinical team on all relevant issues involving data that potentially influenced statistical analyses.

Outsourcing Management:

Coordinated, managed and documented Data Management and data collection activities for outsourced (CRO) trials.

Reviewed vendor proposals and gathered requirements for drafting Requests for Proposal as they related to Scope of Work (SOWs) and potential Out of Scopes. Ensured that CRO/third party vendors adhered to timelines and contractual items.

Responsible for management of CROs and other vendors; maintaining relationships and assessing performance.

Organized and lead project meetings with vendors and internal personnel.

Established communication channels between vendor and internal personnel for purposes of status reporting.

Reviewed/approved initial queries generated by in-house personnel or CRO personnel for outsourced trials.

Oversaw resources and mentored vendor staff during the entire project.

Provided protocol and data collection training for CRO staff in both Clinical (Monitoring) and Data Management.

Management / Mentor:

Led search for new coding implementation tool.

Developed SOPs, process guides and other data management infrastructure documents as needed.

Contributed to the preparation of clinical trials and amendments while in working in a cross functional team.

Mentored junior staff on data review techniques while offering leadership and structure allowing them potential job growth.

Trained Clinical and Data Management staff in data review methodology and clinical tools such as RECIST 1.0 and 1.1.

Project Management:

Served as liaison with internal departments and external vendors to ensure CDM objectives were on-target for trials to meet critical timelines.

Coordinated internal teams including data entry team, CRF design team, database developers, SAS programmers, monitors, safety reviewers and Quality Assurance.

Developed project plans for clinical studies and managed against those plans including time, scope, and costs.

Oversaw development of all new studies developed with EDC vendor to ensure consistency of quality and timely delivery.

Sr. Clinical Data Manager, Consultant, Jul 2007 – Jan 2008

ARIAD Pharmaceuticals, Cambridge, MA- Remote from Buffalo, NY

Provide data management consultation to Director of Biostatistics for User Acceptance Testing for pivotal Phase III conducted InForm®.

Oversee data management activities for outsourced Phase I and II trials in oncology.

Perform clinical data review for legacy studies to assist in determination of next steps for database lock.

Develop SOPs, process guides and other data management infrastructure documents as needed.

Sr. Clinical Data Manager, Consultant, Apr 2007- Sep 2007

Outcome Sciences, Cambridge, MA- Remote from Buffalo. NY

Provide data management consultation to project management and senior management in software company building out a research services department.

Review processes and provide direction on process improvement and process implementation needs.

Oversee data management activities and document development for large post-marketing research projects in start-up.

Provide technical skills/knowledge of database structure and development in rescue of post-marketing study.

Develop SOPs and working practices.

Develop presentations and documents in support of business development and marketing efforts.

Project Manager, Apr 2006-March 2007

PharmaPros Corporation, Cambridge, MA- Remote from Buffalo, NY

• Consult with clients (small biotech and newer pharmaceutical companies) to guide them through the clinical research process, often for their first projects in man.

• Provide project management and leadership support to all NCompass (suite of programs and activities built to integrate with and complement ClinTrial 4.5) Services operations, projects and personnel.

• Establish priorities, maintain deadlines, budgets, and resource allocation activities within project scope

• Provide technical skills/knowledge in the use of all NCompass products and services.

• Provide technical training and consulting services.

• Develop SOPs and guidelines.

• Assist in audit preparation and delivery.

• Ensure company and departmental SOPS, policies and procedures are followed.

• Coordinate CRO and partner activities including overseeing several data managers at partner CRO for study services.

• Assist in the preparation of NCompass Services proposals for potential clients.

• Represent Data Management and Project Management in Service proposal meetings for potential clients.

• Responsible for development and management of oncology, infectious disease and device trials.

Clinical Data Manager, December 2001 – March 2006

Millennium Pharmaceuticals, Inc., Cambridge, MA- Remote from Buffalo, NY from Jan 2004

Data Management:

• Contributed to the preparation of clinical trials and amendments while in working in a cross functional team.

• Reviewed protocols, developed project plans, designed case report forms (CRFs), authored CRF completion guidelines, data validation plans (DVPs) / edit checks, draft SAE Reconciliation, Self Evident Corrections, Quality Control Plans, Notes to File and other elements of the data management plan (DMP).

• Developed/tested/approved edit check specifications and finalized output while ensuring consistency/continuity among protocol, CRF design, annotation and clinical database structures.

• Utilized MedDRA and WHODRL coding dictionaries to code clinical data.

• Reviewed and commented on operations documents (e.g., monitoring guidelines).

• Presented at Investigator Meetings.

• Performed all aspects of data review for trials and ensured data was acceptable for database lock.

• Advised clinical team on all relevant issues involving data that potentially influenced statistical analyses.

Outsourcing Management:

• Coordinated, managed and documented Data Management and data collection activities for outsourced (CRO) trials.

• Reviewed vendor proposals and gathered requirements for drafting Requests for Proposal as they related to Scope of Work (SOWs) and potential Out of Scopes due to protocol amendments. Ensured that CRO/third party vendors adhered to timelines and contractual items.

• Responsible for management of CROs and other vendors; maintaining relationships and assessing performance. Organized and lead project meetings with vendors and internal personnel.

• Established communication channels between vendor and internal personnel for purposes of status reporting.

• Reviewed and approved electronic data from CROs/third party vendors for acceptance into clinical database.

• Reviewed/approved initial queries generated by in-house personnel or CRO personnel for outsourced trials.

• Oversaw resources and mentored vendor staff during the entire project.

Electronic Data Capture (EDC):

• Designed, planned, implemented and managed the overall development of clinical research projects utilizing InForm technology.

• Participated in EDC Leadership and Training Committee.

Management / Mentor:

• Trained new staff on internal SOPs, Process Guides, and Database as required.

• Mentored junior staff while offering leadership and structure allowing them potential job growth.

Project Management:

• Served as liaison with internal departments and external vendors to ensure CDM objectives were on-target for trials to meet critical timelines.

• Coordinated internal teams including data entry team, CRF design team, database developers, SAS programmers, monitors, safety reviewers and Quality Assurance.

• Developed project plans for clinical studies and managed against those plans including time, scope, and costs.

• Participated in filings for INDs/ NDAs.

• Authored Department and cross-functional SOPs and Process Guides.

• Provided leadership in creation/maintenance of DVP template and in standardizing edit checks and the DVP process.

• Participated in Clinical Development process improvement meetings with external consultants as a Subject Matter Expert.

Clinical Data Manager, May 1993 – November 2001

Frontier Science and Technology Research Foundation, Inc., Amherst, NY

• Lead data manager for phase I-IV clinical trials.

• Worldwide primary manager for all aspects of two international Phase III Perinatal HIV-Transmission protocols.

• Assisted Primary Investigators in protocol design from concept sheet phase; wrote all data management associated areas of protocols and reviewed all drafts and updates of all protocol sections.

• Assured data collected would meet scientific objectives as defined by the protocol document.

• Developed CRFs and wrote CRF completion guidelines.

• Designed, reviewed and implemented logical checks for the pediatric section.

• Developed quality assurance monitoring plans to guide data review throughout study cycle.

• Generated manual queries (clinical as well as logical), resolved and integrated data queries.

• Prepared reports and lead team review at significant time points during study conduct.

• Primary contact for site personnel for protocol conduct, data collection, data error resolution and problem solving

• Interacted with Site Monitoring personnel and other contractors to plan study specific site training or resolve problems related to data collection discrepancies at clinical trials units.

• Worked closely with protocol statisticians and medical monitors to complete data review and preparation for analysis.

• Wrote program documentation and SOPs

• Active in Pediatric Aids Clinical Trials agenda and thought leadership through participation on the following committees: Perinatal Research Agenda Committee, Obstetrical Subcommittee of the Perinatal Research Agenda Committee, Supportive Care/Quality of Life Committee, Neurology and Neuropsychology Committee, Statistical and Data Management Center Pediatric Standardization Committee, Data Management Center Core Data Management Leadership Committee, Data Management Center Edit Check and Logical Check Development/Standardization Committee, Forms and Data Reduction Subcommittee of the Pediatric Executive Committee

TECHNOLOGY:

Medidata RAVE electronic data capture, InForm electronic data capture, ClinTrial, eRT Data Management System (eDM), SQL, Toad (Sequel Assist), Oracle Discoverer, Ingres, Iquel, Quel, SAS, Spotfire, Word Perfect, Microsoft Word, Excel, Project, Lotus 1-2-3, FrameMaker, Windows, Internet Explorer, Netscape, Microsoft Outlook, Outlook Express and Eudora

PROFESSIONAL MEMBERSHIPS:

Drug Information Association

Society for Clinical Data Management

Data Quality Research Organization

EDUCATION:

Master of Science in Education, Reading, May 1990

Canisius College, Buffalo, New York.

Bachelors of Arts in English/Bachelors of Arts in Psychology, May 1988

Canisius College, Buffalo, New York.

HONORS:

Outstanding Young Women of America

Who’s Who Among Students in American Colleges and Universities

Canisius College Di Gamma Honor Society

REFERENCES:

Available upon request

Primary CDM Experience/Infinity Pharmaceuticals:

• Phase 2 study to determine the efficacy of IPI-926 in patients with myelofibrosis (MF) (primary myelofibrosis [PMF], post-polycythemia vera myelofibrosis [post-PV MF], or post-essential thrombocythemia myelofibrosis [post-ET MF]), responsible for all study start-up activities, transitioned to another data manager for oversight once all trial materials were created and site training completed.

• Phase 2, double-blind, placebo-controlled, multicenter, trial evaluating the safety and efficacy of IPI-926 in patients with metastatic or locally advanced (unresectable) chondrosarcoma. The study includes an optional cross-over to open-label IPI-926 for patients randomly assigned to placebo who experience documented disease progression, assisted with study start-up activities, transitioned to another data manager for oversight once all trial materials were created and site training completed.

• Phase 1b/2 clinical trial to evaluate IPI-926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer, assumed management of trial in cooperation with senior CDM failing to meet timelines. Assumed full responsibility of trial and oversaw EDC upgrade to resolve data collection issues and proceeded to manage trial to timelines with a team of 2 additional data management resources.

• Phase 1 Study of IPI-926 in Patients With Advanced and/or Metastatic Solid Tumor Malignancies, assumed management of trial due to concerns raised by clinical operations as to data collection review practices and data cleanliness.

• Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC, responsible for all study start-up activites, passed on to another data manager for oversight once all trial materials were created and site training completed.

• Phase 2, Double-Blind, Placebo-Controlled Study of IPI-504 and Docetaxel in Previously Treated Patients With Stage IIIB or IV Non-Small Cell Lung Cancer, responsible for all study start-up activites, passed on to another data manager for oversight once all trial materials were created and site training completed.

• Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety and Tolerability of IPI-493 in Patients Experiencing Advanced Hematologic Malignancies with Client Proteins of Hsp90, dose finding study, performed with clinics in the United States. Developed disease specific forms, assisted in database architecture, developed all CDM documents.

• A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of IPI-493 Orally Administered to Patients with Advanced Malignancies, took over study to assist more junior CDM in managing and reviewing data, updated CDM documents, added edit checks, improved data review timeline, performed all coding duties, worked with medical reviewer for finalization of data on a patient by patient basis.

• A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of IPI-504 in Patients with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors Following Failure of at Least Imatinib and Sunitinib, global phase III, worked with clinical team and CRO Clinical staff and Clinical CRO staff members in the start-up, implementation and early close out of trial. Presented eCRF at Investigator meetings, performed several on-line trainings for new site and CRO personnel, created and maintained CDM documentation.

• A Phase 1 Study of IPI-504 and Docetaxel in Patients with Advanced Solid Tumors, performed data review and querying, medical coding, updated eCRF Completion Guide to improve quality of document.

• A Phase 2 Open-Label Study to Investigate the Pharmacodynamics and Clinical Activity of IPI-504 in Patients with Castration-Resistant Prostate Cancer Stratified by Prior Chemotherapy, performed data review and querying, medical coding, updated eCRF Completion Guide to improve quality of document.

• A Phase 1 / 2 Study to Investigate the Safety, Tolerability and Potential Activity of IPI-504 in Relapsed and / or Refractory Stage IIIb (with Malignant Pleural or Pericardial Effusion), or Stage IV NSCLC Patients, performed data review and querying, medical coding, updated eCRF Completion Guide to improve quality of document.

• A Phase 1, Safety Assessment and PharmacokineticStudy of IPI-504 in Patients with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors(GIST), performed data review and querying, medical coding, responsible for close out documentation.

Primary CDM Experience/ Millennium Pharmaceuticals:

• Phase I Open Label Study to Evaluate the Safety and Tolerability of PS-341 in Patients with Amyloidosis, early in protocol development- working with a team to transition trial from MPI team to partner company team.

• Phase I Open Label, dose Escalation Study to Evaluate the Safety and Tolerability of PS-341 and Docetaxel Administered in Combination to Patients with Advanced and/or Metastatic Breast Cancer Previously Treated with an Anthracycline-Containing Regimen, expected enrollment of 60 patients in Europe, developed all trial documents and managed trial for 2 years before handing off to other DM personnel.

• Phase II Randomized, Open Label Study of Two Doses of PS-341 Alone or In Combination with Dexamethasone in Patients with Multiple Myeloma Who Have Failed to Respond or Relapsed Following Front-Line Therapy, 56 Patients in the US, managed from DVP development through database lock. Submitted as part of Velcade NDA in December 2002.

• Diagnostic substudy of Cytogenetic testing as a predictor of response to PS-341 in Phase II Randomized, Open label Study of Two Doses of PS-341 Alone or in Combination with Dexamethasone in Patients with Multiple Myeloma Who Have Failed to Respond or Relapsed Following Front-Line Therapy. Collected and reviewed cytogenetic data with team medical monitors to determine if there is a correlation between the cytogenetic results and response to PS-341(Velcade).

• Phase III International, Multi-Center, Randomized, Open-Label Study of PS-341 Versus High-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma, 669 Patients in Europe, Israel and North America, assumed responsibility for trial in rescue situation in August 2003 and have managed through interim database lock and final analysis. Submitted for Velcade sNDA in September 2004. Final database lock achieved in second quarter 2005.

• Diagnostic substudy of Cytogenetic testing as a predictor of response to PS-341 in Phase III International, Multi-Center, Randomized, Open-Label Study of PS-341 Versus High-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma. Collected and reviewed cytogenetic data with team medical monitors to determine if there is a correlation between the cytogenetic results and response to PS-341(Velcade).

• Phase III International Study of PS-341 in Patients with Advanced Multiple Myeloma or Patients Who Experienced PD with Dexamethasone in MPI Study M34101-039, 476 patients in Europe, Israel and North America assumed responsibility for trial in rescue situation in August 2003. Database lock milestone met fall 2005.

• Phase III An Open-Label, Randomized Study of VELCADE /Melphalan/Prednisone Versus Melphalan/Prednisone in Subjects With Previously Untreated Multiple Myeloma who are not Candidates for High Dose Chemotherapy or Autologous Stem Cell Transplant, served as member of cross-company review team for protocol and CRF development with partner company.

• An open label randomized multicenter trial comparing VAD and VELCADE* plus Dexamethasone as induction treatment prior to autologous stem cell transplantation in patients with newly diagnosed Multiple Myeloma up to the age of 65 years, served as member of review team for protocol and CRF development for IIS cooperative study.

• Phase IV Commercial studies, working with commercial and clinical operations groups to develop protocol and CRFs.

Primary CDM Experience/Frontier Science:

• Phase I Study to Evaluate the Safety and Tolerance of Nelfinavir Given with Zidovudine and Lamivudine in HIV Positive Women and Their Infants, 31 Mother-Infant Pairs, limited by viral load testing to maternal pts with viral loads of less than 10,000 copies. Also included genotypic /phenotypic HIV testin,individual and population pk.

• Phase I Study of the Safety and Effectiveness of Ritonavir Plus Lamivudine and Zidovudine in HIV Infected Women and Their Infants, 14 Mother-Infant Pairs, limited by viral load testing to maternal patients with viral loads of less than 10,000 copies. Also included genotypic and phenotypic HIV testing as well as individual and population pk.

• Phase II-III Randomized Trial of Protease Inhibitor-Including vs. Protease Inhibitor- Sparing Regimens for Initial Therapy of HIV-Infection During Pregnancy, 400 Mother-Infant Pairs in the US, limited by viral load testing to maternal patients with viral loads of less than 10,000 copies. Also included genotypic and phenotypic HIV testing as well as individual and population pk.

• Phase III Safety and Effectiveness of Zidovudine in HIV Infected Pregnant Women and Their Infants, 514 Mother – Infant Pairs

• Phase III Study of Nevirapine for Prevention of HIV Transmission from Mothers to their Infants, 1522 Mother–Infant Pairs in US, Puerto Rico, EU, France, Bahamas and Brazil

• Phase IV Long Term Effects of Treatment in Children Exposed to and/or Infected with HIV, 2500 Patients

• Phase IV Study of Perinatal Transmission of ZDV Resistant HIV Among Pregnant Women and their Infants, 16 Mother–Infant Pairs

• Phase IV Safety Follow-up for Women Enrolled into Perinatal HIV-Transmission Study of AZT-Placebo, 200 pts

• Phase IV Perinatal Core Protocol, Primary Goal, Issues of Efficacy and Safety in the Treatment of HIV Infection in Pregnant Women and Their Infants, 2500 Mother-Infant Pairs

PUBLICATIONS:

Mary Culnane; MaryGlenn Fowler; Sophia S. Lee; George McSherry; Michael Brady; Karen O'Donnell; Lynne Mofenson; Steven L. Gortmaker; David E. Shapiro; Gwendolyn Scott; Eleanor Jimenez; Ellen C. Moore; Clemente Diaz; Patricia M. Flynn; Bethann Cunningham; James Oleske; for the Pediatric AIDS Clinical Trials Group Protocol 219/076 Teams

Lack of Long-term Effects of In Utero Exposure to Zidovudine Among Uninfected Children Born to HIV-Infected Women

JAMA, Jan 1999; 281: 151 - 157

Shapiro, D.E., Sperling, R.S., Mandelbrot, L., Britto, P., Cunningham, B.

Risk Factors for Perinatal Human Immunodeficiency Virus Transmission in Patients Receiving Zidovudine Prophylaxis.

Journal of Obstetrics and Gynecology Vol. 94, No. 6, 897-908, December 1999

Alejandro Dorenbaum; Coleen K. Cunningham; Richard D. Gelber; Mary Culnane; Lynne Mofenson; Paula Britto; Claire Rekacewicz; Marie-Louise Newell; Jean Francois Delfraissy; Bethann Cunningham-Schrader; Mark Mirochnick; John L. Sullivan; for the International PACTG 316 Team

Two-Dose Intrapartum/Newborn Nevirapine and Standard Antiretroviral Therapy to Reduce Perinatal HIV Transmission: A Randomized Trial

JAMA, Jul 2002; 288: 189 - 198.

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