Project Manager Clinical Trial

EDUCATION

**/****

Master’s in Health Care Administration (MHA)

University of Phoenix, Phoenix, Arizona

**/****

BS Biology, Minor in Psychology

Long Island University, Brooklyn, NY

EXPERIENCE

05/2022-Now Laekna Therapeutics

Sr. Clinical Project Manager

The Project Manager position is under clinical development function and will be responsible for working with cross-functional project teams to effectively drive drug development from clinical perspective and take the lead role in cross function collaboration.

Responsibilities:

Select, manage, and serve as the primary point of contact with CRO, vendors and study sites

Monitor the quality of CRO/vendor deliverables

Support study document development such as protocol, IB and ICF etc.

Support site management and fully involved in resolving study related issues. - Support KOL management

Study timeline/budget management and clinical trial agreement negotiation. - Ensure that study milestones and budget are met as plan

Smooth cross-functional communication internally and support overall development of clinical studies

Host project meetings, discussions and deliver meeting minutes, track all follow up actions to be done

Project related tasks assigned by line manager such as internal process optimization, communication pathway optimization, organize non-project training for clinical development etc.

10/2016-05/2022 Novartis Pharmaceuticals, East Hanover, NJ

Sr. Global Trial Manager

Contribute, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team.

Contribute to all operational trial deliverables, under the oversight of the (Associate) Global Trial Director, according to timelines, budget, operational procedures, and quality /compliance and performance standards.

Assigned responsibilities include:

Development of specific sections of the protocol and related documents

Development of study tools, guidelines and training materials

Organization and logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee)

Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries)

Supporting forecast and management of drug supply for Novartis and comparator drug products in collaboration with internal stakeholders

Contributing to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); managing interface with CROs in cooperation with outsourcing management and line functions, ensuring vendors meet quality standards, contributing to the development/amendment of vendor contracts

Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and clinical development representative,

Implementing issue resolution plans

Acting as point of contact for all site-related issues and procedural questions

Managing interactions with relevant line functions including data management, drug supply management, clinical development and Novartis Country Pharma Organizations

Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.

Resource Management:

Supports the Global Trial Director with the development, management and tracking of the trial level life cycle budget forecast, and annual cost targets.

Core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes.

Organize and chair trial sub teams within the scope of his/her delegated responsibilities.

Extended member of the Global Clinical Team (GCT).

As member of the CTT, contribute to defining the Data Review Plan, participate in data review as specified in the Data Review Plan.

Contribute to talent development through active participation in onboarding and training activities.

Participate in GDO Trial Management initiatives and working groups.

Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise, including sharing lessons learned.

03/2015 – 10/2016

04/2014 – 03/2015

Regeneron Pharmaceuticals, Inc., Tarrytown, NY

Clinical Operations Associate, Clinical Trial Management

Supports the CTM or project manager with study start up and execution

Interacts with CRO, central laboratory, IVRS systems as needed.

Follows established clinical study standards and procedures to plan and conduct clinical research studies

Assists with and/or may play a lead role in the development of procedures and tools for data collection

Acts as a second point of contact between team members, vendors and study sites to assist with study conduct

Requests, collects and submits site documents

Reviews study start up documents and disseminates to the appropriate functional groups (i.e. legal, regulatory)

Tracks study start up status

Establishes and maintains the study TMF with minimal guidance

Maintains CTMS and acts as a reference point for the CTM department on study status and CTMS management

Compiles and maintains regular status reports of study progress, and ensures information is provided to management

Collates and distributes study related materials

Collates and assembles study binders (regulatory, pharmacy, laboratory), study reference manuals and study data collection tools

Manages and maintains team SharePoint and/or shared drive sites as needed

Maintains study specific timelines, and provides information as needed to the study team

Submits required material to internal review committees (RCRC) and may attend review meetings on behalf of the study team

Requests CDAs and consulting agreements

Participates in tracking and reporting of study data for management reports

Assists with reviewing monitoring visit reports

Accompanies the CTM or CRA on site monitoring visits

Have site management responsibilities

Assists with vendor management

Applies knowledge of company policies and standard practices to resolve problems

Assists with and/or may play a lead role in the development of study documents including informed consent forms, data collection tools and procedure manuals

Maintains open communication channels with study sites and members of the study team to ensure proper study progress

Analyzes issues and uses judgment to make decisions

Escalates non-standard problems or issues as may be required

Participates in process improvement initiatives for the department.

Regeneron Pharmaceuticals, Inc., Tarrytown, NY

Clinical Documentation Associate (Site Start-Up)

Reviewed and approve essential documents in support of site start-up activities

Provided approved essential documents to regulatory affairs for Investigational Product release for both country and site

Completed Site Start-up and subsequent documents tracker

Provided subsequent essential documents to regulatory affairs for submission to the FDA.

Compose and present TMF upload and finalization

Scheduled meetings, agendas and compose meeting minutes

Assisted internal and external study managers in TMF set up

File the essential clinical documents and maintain the TMF

Track and perform quality control of incoming paper essential documents to the TMF

Prepare and transition study documents to long-term archive facility

Maintain archival records

Retrieve study documents from long term facilities when requested

Perform quality control review of documents uploaded in the eTMF for accuracy and completeness, including CRO Documents

Interact with Clinical teams and other internal groups in support of TMF efforts

07/2011 – 04/2014

Mount Sinai Medical Center, New York, NY

Senior Clinical Research Coordinator, Cancer Clinical Trials

Interpretation of highly complex data gathered on clinical research studies

Conduction of clinical testing, developing protocols and assuring all protocol procedures are being approved

Preparation of reports for presentation in conferences and seminars

Development of work flow policies and procedures, preparation of manuals and documents

Overseeing the clinical assessments of the study subjects including evaluation and testing of the subjects as well as overseeing data collection, processing, storage, inventory and quality control for clinical research studies

Keeping a log of all IND (Investigational New Drug) reports

Coordination of protocols and human subject approvals between various sites

Preparation and maintaining of Trial Master Files for all protocols

Preparation of all screened, pre-screened and enrolled subject enrollment logs

Keeping track of all signed protocols, amendments for protocols from the sponsor and Informed Consent Forms

Preparation for audits and keeping all audit paperwork in trial master files

Assisting the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials

Collaboration with Pharmaceutical Companies, regarding study documentations

Conduction of Site Qualification, Selection, Initiation and Monitoring Visits

Establishing a better work flow between research departments

Training other personnel

04/2010-07/2011

04/2009-07/2009

02/2008-07/2008

10/2004-02/2008

SUNY Downstate Medical Center, Brooklyn, NY

Clinical Research Coordinator, Radiation Oncology

Service the department manager in her absence in order to operate and streamline operations

Assisting with coordination of residency programs, employee and resident attending forms

Assisting in identifying eligible residents for interviews through Eras

Scheduling and coordinating interviews between Physicians, Residents and Administrators

Taking initiative in preparing the Department for the JACHO review

Preparing time sheets for payroll

Coordinating vacation logs as well as being responsible for logging in sick days

Coordination of meetings between the department chairman and other personnel within 4 Hospitals

Liaison between research sponsors and other personnel

Assigned to re-draft RTOG protocols to meet IRB requirements

Coordinating IRB requirements for completeness, timeliness and renewal as well as timely data submission to RTOG, in compliance with HIPAA and other regulations

Randomization of eligible patients, gathering of patient information, and collection of data pertaining to RTOG studies

Maintainer of forms and up to date files necessary for Radiation Therapy Oncology Group Studies (RTOG)

Assisting with Department Administrator to assure compliance with Human Resources and other Program Requirements

St. Vincent’s Catholic Medical Center, New York, NY

Administrative Coordinator, Nuclear Medicine

Patient relations, insurance administration, and medical coding duties

Scheduling and educating patients (and families) regarding medical procedures

Constant interface with insurance companies to secure approval for procedures

Liaison between insurance companies, physicians, and administrators

Emphasis on troubleshooting

(Contract Engagement)

Memorial Sloan-Kettering Cancer Center, New York, NY

Research Study Assistant, Breast Surgery Research

Processing patient consent/enrollment in research studies

Extensive data collection, data entry, preparation of chart abstractions, and follow-up on patients under treatment arms

Familiarity with passage of protocols through IRB and HIPAA regulations

Quality assurance training

Research studies targeting: tissue banks, evaluation of treatments, and effects on cancer banks

(Downsized)

Dr. T’s Pediatrics, Forest Hills, NY

Medical Office Administration

Rapid advancement to medical assistant role with key office management, medical coding, and billing roles

Assisting with catheterization and blood drawing procedures

Emphasis on patient relations, referrals, scheduling, liaison between labs and office, processing insurance claims, and responding to billing inquiries

Conducting routine medical tests including rapid strep and urine cultures

Preparing vaccines and administering intra-nasal vaccines

12/05/2023

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