Project Manager Management
Resume:
SANDRA R. HANKINS
RAHWAY NJ, *7065
**********@*****.***
CAREER STRENGTHS
• Over 11 years of clinical manager and project manager experience in conducting Phase 1 through Phase 4 clinical studies in the US and globally in 27 countries around the world.
• Over 5 years of monitoring experience in both the US and internationally.
• Therapeutic area experience includes oncology (hematology and solid tumor), neuroscience (ADHD, MDD, schizophrenia, Tourettes), cardiovascular, respiratory, gastroenterology, hepatology, renal, women’s health, ophthalmology, dermatology and HIV
• Experienced in the use of EDC systems, MedDRA, CTMS and IMPACT.
EDUCATIONAL EXPERIENCE
• North Carolina State University (May 1994), BA: Communications with concentration in Public Relations
• Clinical Project Management Training (January 2011)
PROFESSIONAL EXPERIENCE
OTSUKA (Independent Consultant) Princeton, NJ
Program Manager 07/11 to Present
Provide program management for early phase oncology (heme and solid tumor) and neuroscience (ADHD, Tourette’s, MDD, Schizophrenia) development programs by managing the clinical operations from study start-up through database lock.
Facilitate the review of development projects with senior management and make project strategy recommendations to achieve approved program/project objectives
Functions as a development alliance liaison helping to support development alliance management activities based on program requirements.
Responsible for ensuring smooth transitions between action points from initiating IND through product launch and full life cycle management.
Support quarterly forecasts; manage scope, timeline and financial changes through tracking variances at the program level.
Work with the Product Development Committee and relevant functional areas to lead the development of the Global Development and Commercialization Plan (GDCP) for assigned programs.
Responsible for developing and maintaining good relationships with functional areas to foster positive interactions to achieve desired program/project outcomes.
MILLENIUM PHARMACEUTICALS (Contract Position) Cambridge, MA
Clinical Research Manager II 01/10 to 07/11
Managed clinical operations for assigned hematology and solid tumor oncology clinical projects including timelines, budgets, personnel resources, investigational sites, vendor and key project deliverables.
Prepared clinical sections of protocols, IND submissions, IND annual reports, IB updates, BLA/NDA submissions, NDA annual updates, protocols and clinical study reports.
Worked with Clinical Quality Assurance to respond to site audit reports and implement corrective action plans at the site level.
Oversaw quarterly review of clinical investigator files for compliance with GCPs and Millennium SOPs.
Worked with key opinion leaders on advisory boards to design clinical studies for early development programs.
Provided strategic planning expertise on operational feasibility of clinical development plans and scenarios, including budget and resource estimates.
Worked with the study team (s) to determine patient recruitment strategies, operational feasibility and implementation of study objectives.
Managed, mentored and provided professional development guidance to assigned clinical operations staff members.
Led ongoing study team review of clinical data for safety trends.
NOVARTIS PHARMACEUTICALS (Contract Position) East Hanover, NJ
Compound Project Manager 04/09 to 01/10
Drove the successful and timely execution of hematology oncology programs for six (6) compounds from Phase 1 through Phase 4.
Liaised between the local Country Pharma Organization (CPO) and the global organizations.
Provided input to clinical development plans regarding timelines and study feasibility.
Determined the local CPO level monitoring and clinical resources for assigned projects and monitor US clinical operations resourcing requirements.
Ensured planned recruitment targets are achieved by developing and implementing trial recruitment strategies for assigned compounds and studies.
Acted as US clinical operations representative for international clinical team, medical product team and medical franchises operations meetings.
Monitored US trial level budget and insure project stays within budget parameters.
PFIZER, INC. (Independent Consultant) New London, CT
Global Sr. Study Project Manager (Home-based) 11/07 to 04/09
Project manager for global Phase II ADHD, pain management and hematology and solid tumor oncology clinical studies.
Accountable for study closeout by providing project management for database lock and release activities.
Coordinated the activities and deliverables of all study conduct partners (vendors, cross-functional team) to ensure timely delivery
of quality data for assigned studies.
Responsible for ensuring studies are conducted in compliance with GCP, relevant SOPs and regulatory requirements.
Conducted training of monitors on protocol content and study operation procedures.
Defined monitoring visit plan and schedule, conduct regular review of monitoring reports and address issues with US regional and Pfizer Country Offices management and monitors.
Lead study team review of clinical data for safety trends.
Oversaw US regional and Pfizer Country Offices to ensure that the protocol is appropriately implemented across investigator sites
and countries
Developed study level recruitment and retention strategy plans and oversee implementation of plans at site level.
EISAI MEDICAL RESEARCH, INC. (Independent Consultant) Ridgefield Park, NJ
Manager, Clinical Operations 08/07 to 11/07
Managed the execution of assigned global Phase II/III neuropathic pain clinical studies from protocol development to final CSR.
Assisted sites with the development of patient recruitment strategies.
Responsible for ensuring those operational aspects of clinical study meet time, quality and cost targets consistent with study CDP.
Conducted training of monitors assigned to protocol.
Oversaw vendors working on study to ensure quality of clinical data and timeline adherence.
Reviewed and approved monitoring reports.
§ Mentored Sr. CRAs on project management procedures and policies.
Planned, coordinated and presented at Investigator Meetings.
BRISTOL-MYERS SQUIBB (Contract Position) Princeton, NJ
Clinical Scientist 04/07 to 08/07
Drove the successful and timely execution of assigned global Phase I hematology and solid tumor oncology clinical studies from protocol development to final CSR.
Presented protocol at functional review meeting to ascertain compound feasibility in relation to compound clinical development plans.
Monitored early-phase clinical studies and provide ongoing updates to clinical team.
Prepared clinical protocols, CSRs and other project-related documents.
Coordinated and participated in site selection, site initiation activities, site start-up and patient recruitment.
Participated in the development of study-related documents with input from clinical team.
Proactively managed study to prevent or address problems regarding timelines, budget, resources and quality.
Provided updates to study team on issues that could impact the protocol and propose corrective actions.
MITSUBISHI PHARMA AMERICA, INC. (Contract Position) Warren, NJ
Project Manager, Clinical Research 07/06 to 04/07
Assisted with the design and implementation of global cardiovascular, metabolic and renal clinical trials including thorough Phase 1 QTc trials and provided day-to-day management of assigned clinical trials.
§ Recruited, approved and monitored investigator sites.
§ Coordinated with clinical development colleagues in Europe and Japan to set strategic goals for compound development.
§ Supported the Medical Director and collaborate with international counterparts through global project team.
§ Presented monthly presentations and bi-weekly presentations to global project team and upper management regarding study activities.
§ Served as primary interface between sponsor and vendors (CROs, global monitors, central labs and PIs/investigator sites).
§ Authored/reviewed SOPs when requested.
SCHERING-PLOUGH RESEARCH INSTITUTE Kenilworth, NJ
Project Leader 06/05 to 07/06
§ Worked cross-functionally, domestic and internationally, to conduct the activities associated with the implementation, execution and close-out of hepatology and gastroenterology HEOR clinical studies.
§ Conducted monitoring and co-monitoring visit domestically and internationally to gauge site compliance with GCP/ICH guidelines and SPRI SOPs.
§ Responded to site audit reports generated from SPRI’s internal auditing group.
§ Assisted with the development of informed consents, study-related training materials, clinical supplies forecasting, site identification and development of site selection/qualification criteria.
§ Responsible for the overall study planning, tracking and reporting of study progress.
§ Delegated study team activities as assigned to ensure study completion consistent with established timeframes, budget and in compliance with all applicable GCP/ICH guidelines and SPRI SOPs.
PharmaNet Charlotte, NC
Manager, Clinical Research 09/04 to 06/05
§ Managed interdisciplinary clinical research projects in dermatology and ophthalmology, as Project Manager, leading the clinical team to ensure on-time, on-budget performance.
§ Authored of the Protocols, Protocol Synopses, CRF Review Manual, Clinical Study Reports and Annuals Reports.
§ Trained CRAs on monitoring, internal procedures and query resolution.
§ Reviewed and approved expensing for research projects.
§ Responsible for project budgets and quarterly forecasting.
§ Prepared project management reports for clients, project personnel and PharmaNet management.
§ Reviewed and approved monitoring reports.
§ Mentored Sr. CRAs on project management procedures and policies.
ASTRAZENECA PHARMACEUTICALS, LP Wilmington, DE
Clinical Research Scientist 06/03 to 09/04
§ Served as study co-lead for day-to-day operational activities for large, global, multi-center (800 sites) HEOR cardiovascular study.
§ of the internal site management staff.
§ Served as internal contact for regional monitoring team (35 monitors) assigned to study.
§ Co-monitored sites with regional monitors to gauge compliance with AstraZeneca SOPs, ICH guidelines and FDA regulations.
§ Conducted training of regional monitoring team and internal site management team.
§ Served as member of study leadership team.
GLOBOMAX, LLC Hanover, MD
Senior Clinical Coordinator 06/02 to 06/03
§ Managed Phase I and Phase III clinical trials in oncology and smoking cessation.
§ Managed day-to-day interaction with study sites.
§ Conducted training of clinical research associates.
§ Tracked and reviewed monitoring activities of monitors assigned to study.
§ Assisted with the design and structure of the study monitoring plan.
§ Provided sponsor weekly update reports on screening, enrollment, withdrawal rates, etc.
§ Developed SOPs for conducting Phase II/II clinical trials.
GLAXOSMITHKLINE, INC. (Contract Position)
Research Triangle Park, NC
Clinical Study Coordinator 12/01 to 05/02
§ Managed study start-up activities for a multi-center (80 sites) global phase III pediatric respiratory clinical trial.
§ Managed CRO study management activities.
§ Audited CRO central files and project files for completeness and accuracy.
§ Reviewed informed consents, diary cards, case report forms and source documents for completeness and accuracy.
PPD DEVELOPMENT, INC. (Contract Position) Research Triangle Park, NC
Clinical Research Associate 09/01 to 12/01
§ Functioned as the primary liaison between the sponsor and the study site for a global Phase III antibiotic clinical trial.
§ Monitored study sites to ensure site adherence to protocol.
§ Managed and organized clinical research official files in compliance to FDA guidelines as well as PPD SOPs (IRB and GCP).
GLAXOSMITHKLINE, INC. (Contract Position) Research Triangle Park, NC
Clinical Study Coordinator 08/00 to 09/01
§ Managed study start-up activities for HIV studies in the US and internationally.
§ Managed CRO study management activities.
§ Audited central files and project files for completeness and accuracy.
§ Reviewed informed consents, diary cards, case report forms and source documents for completeness and accuracy.
Clinical Data Coordinator 05/00 to 08/00
§ Reviewed clinical data against project specifications and wrote data clarifications form to the sites.
§ Performed data review and quality control tasks.
§ Conducted audits of case report forms and data clarification forms to check for accuracy and ensure timely database lock.
§ Annotated case report forms once data clarification forms are received in-house.
TRIANGLE PHARMACEUTICALS, INC. Durham, NC
Executive Coordinator, HIV Clinical Research 01/00 to 05/00
§ Proofread documents, reports and letters for content and edited as needed.
§ Gathered, analyzed and sorted clinical data based on content.
§ Analyzed clinical data trends and advised of significant changes or discrepancies.
§ Analyzed and wrote summary of large incoming reports. May draft section of entire report as directed by manager.
GLAXOSMITHKLINE, INC. (Contract Position)
Research Triangle Park, NC
Clinical Study Coordinator 4/99 to 12/99
§ Managed study start-up activities for CNS and respiratory studies in the US.
§ Functioned as the primary liaison between the sponsor and the study site.
§ Set-up maintained and audited central files and project files for study per FDA and SOP regulations and guidelines.
§ Ensured proper dispensation and accountability of clinical trial material.
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