PROFESSIONAL EXPERIENCE:

International Trial Manger (Contract)
Confidential,Bridgewater, NJ
November 2011 to March 2012

Provides leadership to multi-functional clinical trial protocol teams for overall operational planning and management for Ph I studies in support of global and local regulatory filings including IND life cycle management programs across multiple therapeutic areas
Ensure that clinical trials are in compliance with ICH, GCP’s, SOPs, local requirements, internal/departmental guidelines, and established timelines.
Serves as internal consultant on assigned area and liaise with external organizations on projects

Establish and promoted good working relationships with Investigators and site research staff

Managed outsourced activities provided by various external vendors

Responsible for developing the study budgets and negotiating the study budgets with the sites

Responsible for sign off of study contracts (and contract amendments) with the sites

Develop and directed site training during site initiation phase

Travel to field sites, observed cases, provided support for site research staff, prepared written reports on procedures, and ensured proper collection of data

Supervise patient screening and enrollment at clinical sites

Review source documentation, case report forms (CRF), and data reports for accuracy

Perform continuous in-house data review and contributed to protocol data review meetings

Identify, prepared written reports and follow-up for all serious or unexpected adverse events

Recognize problems and implemented methods to improve conduct of clinical study

Support company goals, objectives, policies, and procedures

Operations Manager/Project Lead (Contract)
Unigene Laboratories, Inc., Boonton, NJ
December 2010 to June 2011

Provided leadership to multi-functional clinical program team and management of all operational components of clinical trials for Ph I-II studies in support of global regulatory pre-IND submission planning for Satiety program and execution of Phase II POC study within Osteoporosis program.
Served as primary contact for functional area representatives in managing all aspects of protocol execution.
Planned, set-up, and managed trial communication plan including investigator, monitor, and operational team meeting schedules; overall drug supply, and management and provision of other study materials in accordance with project and study level plans
Followed established clinical study standards and procedures to plan and conduct clinical research studies.
Developed procedures and tools for data collection as needed.
Developed, reviewed, and/or provided input into study documents (monitoring guidelines, CRF instructions, and study budget template
Performed data review and provided on-site study file monitoring
Accountable for facilitating, tracking, and monitoring the progress of study activities and budget
Developed study documents, including update to existing protocol, informed consent forms, CRFs and CRF instructions, and procedure manuals.
Maintained open communication channels with study sites and members of the study team.
Managed study drug coordination with Manufacturing group

Clinical Scientist (Contract)
Confidential, Princeton, NJ
October 2009 to July 2010

Provided leadership to multi-functional protocol teams and management of the operational components of clinical trials for Ph I-IIa studies in support of global regulatory filings including IND, NDA, MAA and life cycle management programs within Metabolism and Neuroscience early development teams.
Independently managed the successful and timely execution of assigned clinical trials from protocol development to final clinical study report within established budget and quality standards with high degree of autonomy.
Interacts and managed stakeholder expectations with functional groups outside of Discovery Medicine and Clinical Pharmacology, to facilitate the successful development and implementation of assigned studies.
Operationalized multiple protocols within and/or across program(s), and/ or site(s) using project management tools.
Proactively identified potential risks that could impact project performance and/ or outcome and develops contingency plans and necessary actions to prevent or address problems regarding timelines, budget, resources and quality.
Co-authored and/or provides input into key study documents such as protocols and clinical study reports and participates in the development of rationale, objectives and protocol design to ensure consistency within program(s).
Drives and provides leadership for the development of study related documents with the input from team members: (e.g. operational components of the protocol (site monitoring plan, risk management plan, CRF instructions, study tools, informed consent, etc)).
Drives the operational components of study including site feasibility and selection, site initiation activities, site start up and patient recruitment, and preparation and/or review of appropriate clinical and regulatory documents.
Reviewed and provides input on CRF development and data review and analysis plan to ensure that all protocol required data points are captured.
Lead process improvement teams and initiatives.

Sr. Early Clinical Development Specialist/Scientist (Contract)
Confidential, Rahway, NJ
May 2008 to June 2009

Assisted clinical monitors to oversee the conduct of Phase I Experimental Medicine clinical trials which includes but not limited to: protocol design and strategy, patient profile medical review, SAE narratives, medical issue resolutions, preparation for pre-study visit meeting with investigators.
Authored clinical sections of protocols, clinical study reports, WMA/CTD subsections, and regulatory agency update reports, as well as clinical development and experimental medicine plans, publications, and abstracts.
Supported Clinical Monitors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations etc., including those requiring in-depth understanding of individual studies and the integration of clinical study data.
Developed the study-monitoring plan and supplement the standard data review plan for clinical studies.
Conducted and/or supervise clinical study monitoring activities in accordance with Merck and GCP/ICH guidelines.
Served as the primary site contact for all operational and protocol issues in support of clinical research studies. Communicate with sites on issues related to protocol conduct, regulatory documents/requirements and financial payment schedule.
Escalated critical protocol-specific medical issues to the Clinical Monitor as appropriate.
Discussed protocol design with site and coordinate/conduct the appropriate protocol specific training necessary to conduct a study.
Conducted literature reviews and draft background sections of documents.
Worked closely with contributing authors such as statistician, Clinical Monitors, Global Clinical Supplies Operations, preclinical groups, etc.
Lead departmental strategic process improvement initiative for External Services and Outsourcing.
Authored, reviewed, and approved global consent form(s), conducting informed consent and template language negotiations with sites and Institutional Review Boards (IRBs), in accordance with approved guidelines.
Liaised with PICS group as needed for relevant guidance for consent negotiations.
Compiled, reviewed and submitted regulatory documentation required for clinical study initiation, co-author sections of the Investigational New Drug application (IND) and Investigational Medicinal Product Dossier (IMPD), and work with the Clinical Monitor on responses to agency queries.
Reviewed and monitor required regulatory documentation for study maintenance and study closeout.
Managed budgetary matters for clinical trials, including assisting in the creation of and adhering to study budgets and approving payment to sites and vendors based on quality/cycle time metrics.
Managed program and study clinical supplies, including shipment to study sites.
Monitored/authored, and follow up on site monitoring visit reports.
Reviewed and summarized study data to identify potential trends, issues, and/or outliers during recruitment and through the conduct of the study.
Executed medical monitoring plan for patient safety and efficacy results with Clinical Monitors guidance, investigate details of individual cases as needed, determine overall implication to study conduct, and provide updates to clinical team as appropriate.
Developed, trained sites, and ensured administration of endpoint collection procedures (including quality control measures) to enable use of tools in subsequent clinical trials.
Managed and reported serious adverse events to ensure compliance with MRL reporting requirements and resolve outstanding issues. Create and/or edit case narratives. Interact directly with study site(s), subsidiary personnel, and Worldwide Product Safety.
Represented functional area as a member of teams, including the protocol development team, Early Development Team (EDT), Product Development Team (PDT), cross functional teams, process improvement initiatives, etc.
Assisted in the preparation and/or delivery of functional area training to junior staff members and other collaborating functional areas supporting clinical development.
Interacted with key opinion leaders and external scientific advisors by organizing consultant’s meetings. Assemble meeting backgrounders and issue meeting minutes.
Supported clinical research advisory committee presentations by assembling background materials, primary presentations, and back up slides.
Promoted communication of best practices and participate in drafting or review of departmental SOPs

Clinical Research Scientist (Contract)
Confidential, Jersey City, NJ
June 2007 to May 2008

Monitored the conduct of a Ph III international clinical trial within the Internal Medicine clinical development team.
Authored and or modify study synopses, protocols, protocol amendments, monitoring plan and informed consents for in support of the Milnacipran program.
Performed cross patient medical data review through to data freeze and audit response.
Assisted in planning Investigator Meeting and virtual site meetings.
Contributed to the preparation of the Milnacipran NDA (eCTD submission), IND annual reports, ISS, and ISE.
Prepare in collaboration with Biostatistics study report shells.
Contributed to the review drafts of study reports.
Evaluated and manage CROs and vendors (patient recruiting services, labs, centralized ECG, ePRO) for participation in programs.
Provided ongoing review of efficacy and safety outputs and query information as appropriate.
Participated in the development and review Statistical Analysis Plans.
Navigated through clinical site operational questions during conduct of the clinical trial.
Established and revise timelines for studies/projects.
Closely monitor, track, and report clinical trial progress to senior management as appropriate.
Interacted with PR & D to ensure that there are adequate clinical supplies for a given clinical trial.
Reviewed clinical supplies package diagram and labeling.
Reviewed edits check specifications with Data Management.
Assisted with preparations for advisory board and regulatory agency meetings.
Contribute to scientific/clinical evaluation of potential in-licensing candidates.
Interacted with Marketing to support commercialization of products.
Attended internal scientific and project planning meetings.
Contributed to the development of documents such as INDs, ISE, and ISS.
Assisted in preparing briefing books, abstracts, manuscripts, poster presentations of clinical study findings and results.

Clinical Research Specialist (Contract)
Confidential, Rahway, NJ
June 2006 to June 2007

Monitored the conduct of worldwide Ph III clinical trials within the Cardiovascular/Atherosclerosis disease therapeutic area.
Support the MRL Clinical Monitor by developing detailed study design specifications, protocol and protocol amendments, medical monitoring of study data, SAE reporting and reconciliation and summarizing results for assigned clinical trials.
Responsibilities include daily monitoring of safety data, tabulation of patient data, selection of investigational sites, and writing clinical summaries.
Worked as a contributing author for the Clinical Study Report and Laropiprant eCTD
Developed the list of appendices and constructed tables in support of safety data.
Served as scientific subject matter expert in the development of clinical trial deliverables produced by other functional areas (to include data collection tools, vendor specifications, site assessment questionnaires, clinical study report tables, etc), to ensure consistency with the protocol.
Managed endpoint collection procedures to include liaising with external vendors to provide service agreement specifications and provide guidance / issue resolution on scientific aspects of the clinical trial.
Ensured that vendor performance is acceptable and is meeting contractual obligations.
Provide support to ensure that program objectives are achieved.
Proactively identify potential site and or study issues to take corrective actions such as documentation of protocol violations.
Served as point person for non-medical questions from the sites and other team members regarding study conduct and protocol.
Collaborated with Clinical physicians for response to medical questions.
Collaborated with other internal teams such as Clinical Operations, Biostatistics, and Data Management
Ensured that site personnel are fully trained on study specific activities.
Prepared presentations, which include posters, oral presentations, abstracts/publications, etc.
Facilitated and chaired clinical meetings as required.

Project Manager
Confidential,Edison, NJ
November 2004 to February 2006

Managed project timelines and milestones for a variety of projects using Electronic Data Capture (EDC) of clinical trial data for pharmaceutical and biotechnology companies.
Developed detail study design specifications with client.
Managed the complete project development life cycle
Therapeutic areas include: Oncology, Cardiovascular, Pain Management, and Central Nervous System
Lead client and internal status meetings.
Problems tracked through timely resolution.
Pro-active communication with all stakeholders.
Responsibilities included project finance, budget tracking and accuracy of invoicing.
Mentored newly hired Project Managers in effective Project Management methodology.
Participated in organization strategic assignments and internal projects.
Effectively manage larger complex clients / multiple projects.
Provided mentoring and guidance on project management principles for all assigned project team members.
Assure compliance with standard project management methodologies and SOPs.
Managed assigned project resources on an ongoing basis.
Providing on-going feedback regarding performance of all project team members.
Managed scope, change, client expectations, and risks for all projects.
Developed client relationship as trusted advisor role through effective proactive project management.
Maintained effective utilization rates and project billing rates as established in individual goals.

SKILLS:

Software: MS Project, MS Word, MS Excel, MS PowerPoint, MS Outlook, Lotus Notes, Med-Finance, Med-Track

Databases: Clinical Trial Management System, Trial Master File (TMF), CPC2000, MS Access, Oracle Clinical 4.0 (TMS, AERS), NWAES, Clintrial 3.3.3, Integrated Review V6.05, CTS V8.3 (Oracle Based Data Management System), Business Objects, Electronic Data Capture (EDC), IVRS, CSOPs, CARAT, CARA, Reference Manager, Invivo (ePRO), SAS Modules: SAS 6.12, SAS V8
Other: Martindale, GOLD, PDR, Quick Arrow

THERAPUETIC AREAS: Oncology, Osteoporosis, Metabolism/Diabetes, Neuroscience, CNS, Pain Management, Cardiovascular, Pulmonary, and Immunology

EDUCATION:

Executive Master of Science Business Administration
Bachelor of Arts, Psychology