SUMMARY:

• 15 years of experience in clinical development (domestic and international) providing clinical research expertise, knowledge of drug development process, site monitoring leadership, and clinical project management
• Conducting clinical trials according to Confidential and Confidential Good Clinical Practices (GCPs) regulations/guidelines, and to company Standard Operating Procedures (SOPs) and policies (Internal, external, governmental & financial)
• Phases of clinical research includes early development/experimental medicine/Phase I as well as Phase II & III
• Managed large scale global clinical trials e.g. Phase II - 2000 Patients in 21 Countries & Phase III - 16500 patients in 64 countries
• Provided process expertise and technical guidance to study teams on an ongoing basis. Developed content for training materials and job aids. Delivered training sessions in various formats. Collaborated cross-functionally and with Clinical Research Country Leads to compile a knowledge base of external country requirements/templates, internal standards, industry trends, and site templates; ensure information is readily available. Collaborated with external partners, CROs, KOLs, and vendors to ensure training is consistently delivered and recorded

WORK EXPERIENCE:

Confidential, Fair Lawn, NJ

Senior Manager, Clinical Operations

Responsibilities:

• Ensuring all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards: development of study tools and guidelines to ensure consistency in study implementation and management at site, management of clinical study material, implementation of issue resolution plan
• Participating in development of protocol, case report form, CRF guidelines and other study process documents.
• Participation in the preparation of Clinical Study Reports (shell and appendices), annual Investigator Brochure (IB) updates and other scientific documents as assigned
• Preparation of clinical outsourcing specifications and in the follow up with day to day operation with vendors
• Coordination of the trial monitoring board activities (i.e., Adjudication Committees and Data Monitoring Committees) as assigned
• Quality-driven, timely execution of global clinical trials in compliance with international and local regulations and Confidential internal standards
• Managing the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities; manage scopes of work/budgets/invoice payments
• Implementing study subject recruitment and retention strategies
• Ensuring the training of CROs/investigators on protocol, regulatory, SOPs and data issues.
• Timely submission and delivery of high quality clinical trial documents to achieve critical milestones
• Collecting and analyzing historical patterns to facilitate milestone projections, identify potential country/study sites and consider recruitment and retention strategies.
• Providing scientific review and feedback for in-licensing drug compounds or out-licensing in-house drug candidates
• Providing scientific input and/or prepare data summary for confidential and non-confidential data packages

Confidential, King of Prussia, PA

Senior Study Management Associate

Responsibilities:

• Coordinating the efforts to collect, review and converting 3 ongoing studies from paper files/documents to an electronic Trial Master File system that is PAI Pre-Approval Inspection ready
• Reviewing, categorizing and ensuring adequate closure to protocol deviations to ongoing studies
• Liaising with QA to develop a Clinical PAI readiness plan for current dermatology programs
• Assuring compliance of monitors, consultants, investigators, and vendors with standard operating procedures and guidelines, and good clinical practice
• Conducting clinical trials according to Confidential and Confidential Good Clinical Practices (GCPs) regulations/guidelines, and to company Standard Operating Procedures (SOPs) and policies (internal, external, governmental & financial), including site management based upon Risked Based Monitoring
• Providing process expertise and technical guidance to study teams on an ongoing basis, collaborating cross-functionally to compile a knowledge base of requirements and standards, industry trends, ensuring information is readily available
• Reviewing clinical plans and study protocols; providing feasibility assessment, study timelines, and study budgets to senior management; analyzing project goals and key milestones and validating the critical path to ensure quality deliverables

Confidential, Wellesley, MA

Clinical Trial Operations Manager

Responsibilities:

• Conducting Pre-Approval Inspections (PAI)
• Ensuring current programs were “Inspection Ready” prior to submission to Confidential
• Helped maintain the “War Room” during Confidential inspections
• Responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use and registries) including oversight of data management activities in compliance with GCPs, SOPs and standards within established timelines and budgets.

Confidential, Parsippany, NJ

Clinical Study Manager

Responsibilities:

• Direct strategic outsourcing and manage internal resources for clinical study execution; ensure adequate support of projects; develop project timelines and ensure accurate and timely updates
• Review clinical plans and study protocols; provide feasibility assessment, study timelines, and study budgets to senior management; analyze project goals and key milestones and validate the critical path to ensure quality deliverables
• Assure compliance of monitors, consultants, investigators, and vendors with standard operating procedures and guidelines, and good clinical practice
• Ensure that Clinical Operations strategy, goals, and critical processes evolve in accordance with Company standards and GCP/ Confidential requirements
• Serve as direct line manager for the Clinical Operations personnel assigned to specific projects; oversee all project and site management activities for trials; mentor and develop clinical operations staff

Confidential, Milford, CT

Clinical Manager

Responsibilities:

• Supported all aspects of clinical trial(s) (phase II through lifecycle management) as assigned.
• Ensured all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards: developed study tools and guidelines to ensure consistency in study implementation and management at site, management of clinical study material, implementation of issue resolution plan
• Prepared clinical outsourcing specifications and in the follow up with day to day operation with vendors
• Managed trial allocation and coordination of activities leading to site initiation
• Coordinated the trial monitoring board activities (i.e., Adjudication Committees and Data Monitoring Committees) as assigned
• Executed quality-driven & well timed global clinical trials in compliance with international and local regulations and Novartis internal standards
• Submitted and delivered high quality clinical trial documents to achieve critical milestones
• Collected and analyzed historical patterns to facilitate milestone projections, identify potential country/study sites and consider recruitment and retention strategies.
• Performed in-house monitoring of data entry into EDC Clinical database, data review and reconciliation of outstanding queries
• Performed manual data review, generate data queries and issue the data queries to the site and communicated with the CRO all discrepancies that were found

Confidential, Metuchen, NJ

Clinical Operations Lead

Responsibilities:

• Participated in development of protocol, case report form, CRF guidelines and other study process documents.
• Participated the preparation of Clinical Study Reports (shell and appendices), annual Investigator Brochure (IB) updates and other scientific documents as assigned
• Managed the Informed Consent process by ensuring consistency of information throughout all ICFs for a study in compliance with documented internal guidelines and the ICF global templates in collaboration with, Clinical Operations, Safety, and Legal
• Managed the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities; manage scopes of work/budgets/invoice payments
• Implemented study subject recruitment and retention strategies
• Prepare and/or review regulatory documents (e.g. ICF), contracts, Requests for Proposal (RFP).
• Ensure the training of CROs/investigators on protocol, regulatory, SOPs and data issues.
• Reviews and approves monitoring reports and ensures tracking of ongoing site issues.
• Participated in the development and launch of an Extended Application Program (Compassionate Use) liaising between regulatory agencies and the Investigators/Physicians

Confidential, Princeton, NJ

Senior Regional Clinical Research Associate

Responsibilities:

• Gathered essential documents and conducted study start-up activities
• Verified site study files for completeness and accuracy
• Monitored and managed clinical trials in the US and Canada as contracted by sponsor companies
• Investigator/Site Recruitment
• Conducted Pre-study, Initiation, Interim Monitoring, and Closeout Visits

Confidential, Rockville, MD

Clinical Scientist

Responsibilities:

• Lead for xUS regions of Eastern & Western Europe, Russia and Ukraine
• Supervised, planned and coordinated clinical trial set-up and execution. Participate in development of protocol, case report form, CRF guidelines and other study process documents
• Served as the central point of contact and effectively manage relationships between members of the trial teams, CROs, sites and third party vendors.
• Developed ICF global templates in collaboration with, Global Clinical Operations, Safety, and Legal
• Managed the Informed Consent process by ensuring consistency of information throughout all ICFs for a study in compliance with documented internal guidelines
• Supported and participated in the development of feasibility criteria for clinical programs
• Established timeline projections and study specific recruitment strategies
• Obtained local and regional country specific insurance policies that fall outside global coverage
• Participating in the selection of investigators and study sites
• Collaborate as part of the Study Team with Data Management, in the development of case report forms and participate in the EDC process, when appropriate
• Participated in the planning of investigator meetings and making presentations as required
• Participated in the preparation of project-specific training programs and training materials
• Participated in the review of clinical data at the CRF, data listing, and report table levels
• Conducted retrospective analysis (Lessons Learned) at completion of clinical trials

Confidential, Edison, NJ

Sr. Clinical Research Associate

Responsibilities:

• Managed large scale global clinical trials (Phase II - 2000 Patients in 21 Countries & Phase III - 16000 patients in 64 countries) in the North and South America, Eastern and Western European, and the Asia - Pacific regions per Confidential and Confidential Good Clinical Practices (GCPs) regulations/guidelines
• Selected and managed global vendors including CROs, meeting planners, translation providers, central laboratories, IRBs, insurance brokers, central ECG vendors, electronic data capture (eDC) providers
• Executed global clinical trial management: Supervised, planned and coordinated clinical trial set-up and execution. Participated in development of protocol, case report form, CRF guidelines and other study process documents
• Developed ICF global templates in collaboration with, Global Clinical Operations, Safety, and Legal
• Managed the Informed Consent process by ensuring consistency of information throughout all ICFs for a study in compliance with documented internal guidelines
• Reviewed study pertinent documents for accuracy including protocols, study specific Operations Manual Clinical Study Reports Investigator’s Brochures, Data Monitoring/Safety Committee Charters, Monitoring Plan, Statistical Analysis Plans, Data Management Plans and edit specifications, IVR Plans, Investigational Product Plans
• Obtained local and regional country specific insurance policies that fall outside global coverage
• Prepared clinical section of Confidential Annual IND Review Document
• Coordinated appropriate specific protocol training site and site management personnel
• Planned and executed global investigator meetings, Date Safety Committees, and Adjudicating Committees

Confidential, Raritan, NJ

Clinical Research Associate

Responsibilities:

• Development ICF global templates in collaboration with, Global Clinical Operations, Safety, and Legal
• Ensured consistency of information throughout all ICFs for a study in compliance with documented internal guidelines
• Liaised with other Johnson & Johnson R & D companies on integrating electronic data capture into their clinical trials
• Trained investigators and staff on protocol specifics and use of electronic data capture technology
• Maintained documentation of all activities related to site selection, monitoring, data collection and verification.
• Monitored subject dosing and assessment
• Initiated drug requests and maintains adequate supply at investigational sites.
• Ensured on-going communication with internal study personnel including the Project Leader, Clinical Research Scientist, Medical Monitor, Bio-statistician, Data Manager, Regulatory Associate, QA, and Clinical Research Manager (CRM)
• Readied and participated in QA, Confidential and Foreign regulatory agencies inspections audits

Confidential, Stamford, CT

Senior Clinical Research Associate

Responsibilities:

• Execution of global clinical trial management: Supervised, planned and coordinated - including trial set-up and execution, budget management, patient recruitment/retention, clinical database development, execution & closure oversight, and clinical supplies management
• Participated in the development of departmental Standard Operating Procedures and Working Practice Documents (SOPs/WPDs)
• Managed the Informed Consent process, ensuring compliance with internal and external requirements
• Gathered essential study documents (including Confidential Form 1572, DEA forms 222 and 223, Investigational Review Board (IRB) required documents - approved Informed Consent, protocol approval, etc
• Monitored and managed clinical trials in the North and South America per Confidential and Confidential Good Clinical Practices (GCPs) regulations/guidelines
• Development Case Report Forms (CRF) and data completion guidelines
• Developed/Maintained Clinical Monitoring Plan
• Ensured on-going communication with internal study team
• Initiated drug requests and maintained adequate supply at investigational sites.