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Click here or scroll down to respond to this candidateCandidate's Name , PMPClinical Trial ContractorStreet Address
Email: - EMAIL AVAILABLEPhone Number: PHONE NUMBER AVAILABLESUMMARY:Project Manager/ Senior Project Manager with ten years of experience in the pharmaceutical industry. Highly experienced; study manager, vendor manager, site manager (patient recruitment), budget manager (accruals, invoice approval, bid defenses), and study startup/closeout process manager. I possess excellent leadership, excellent and prompt execution skills, observation skills, writing skills, communication skills, and the ability to work in a constantly changing pharmaceutical environment.OVERVIEW OF SKILLS:Highly effective core team member, core team manager ( Medical, Data, finance), and vendor manager (CRO, lab, Drug Depo)Extremely proficient at multitasking, managing timelines, and completing action items ahead of deadlinesSkilled at understanding sponsors' process, study protocol, and study timelines.Excellent patient recruitment, enrollment, and engagement skillsExtremely proficient at multitasking, managing timelines, and completing action items ahead of deadlinesVery proficient with critical clinical trial systems such as:oClinical Trial Management Systems (Impact Harmony, eClinical, BioClinca, etc.)oElectronic Data Capture (RDC, InForm, Veeva vault, Medidata Rave, IMB clinical Dev)oInteractive Voice Response System (ALMAC, Bracket, etc.)oNew Tech System SIP - Shared Investigator Platform and Veeva VaultoElectronic Trial Master File (eTMF) (trial Interactive)Positive attitude and a result-oriented approachStrong Knowledge of GCPs, FDA, and ICH requirementsSuperior work ethicsExcellent interpersonal and leadership skills with an eye for detailExcellent knowledge of MS Word, Access, Excel, Teams, Skype, One Note, Zoom, and Share drives.Experience with Phase I, II, III, Study startup and study closeout,THERAPEUTIC EXPERIENCE:Oncology, CNS, Diabetes, Device, Immunology, Cardiovascular Disease, GastrointestinalEDUCATION:Data Science Canidatate ( Graduation - June 2024) Rutgers-New BrunswickPMP Certified 2020Bachelor of Science in Biology - Bloomfield College, Bloomfield, NJ (BS)Monitoring Oncology Clinical Trials - Barnett International Training ( Certification )TMF For Sponsors Setup and Maintenance - Barnett International Training ( Certification )EMPLOYMENT HISTORYAlcon, TX ( Remote Contract ) July 2021 NowClinical Trial Lead IIILed and matrix-managed global multidisciplinary Clinical Trial Team and Site Management Team for multiple clinical trialsContributed feasibility input for protocol synopsis development and collaborated with Medical Advisors to ensure country feedback was integratedAccountable for the development, management, and tracking of trial budget and accuracy of information in trial databases and tracking systemsWrote scientifically rigorous protocols aligned with approved protocol synopsisDefined clinical outsourcing specifications and oversaw the conduct of tasks for successful trial implementation and execution within timelines and budgets and in compliance with guidelines, regulations, and proceduresLed team of Clinical Site Managers for assigned trials, tracking site progress, milestones, ensuring compliance with PMP and relevant procedures and regulations, and monitoring status of CSM activities.Coordinated, prepared, delivered, and tracked protocol-specific training for site personnel and assigned CSMsEnsured ongoing data quality review, data cleaning, and database lockReported results to Management, CTT/FTT, and Core Team, and managed authoring, review, and approval of Clinical Study Report/Feasibility Trial Summary.Responsible for leading CTT/FTT Meetings, writing minutes, and elevating non-resolved issues to appropriate teams and governance committeeImplemented best practices and standards for trial management, including sharing lessons learnedBayer, Whippany Nj (Remote Contract) Oct 2018 July 2022Clinical Project ManagerResponsible for operational oversight and execution of 3 studies ( Phase I, Phase II, and observational clinical trial in a solid tumor).Responsible for the development of quality project documentation, including project plans, i.e., resources plans, risks strategies, and communication plans throughout the life of the projectAnticipated and resolved challenges affecting the delivery of goals and objectives and liaised with a cross-functional team to influence solutionsDeveloped and implemented study-related operational processes from study initiation, forecasting, budget, and study medication managementManaged external vendors (i.e., CROs, IVRS, etc.) to ensure successfully delivered with quality expectations, timeline, and budget.Lead clinical trial team meetings to ensure cross-functional team member tasks are completed within required study timelines and are accountable for deliverables.Managed and reviewed monthly protocol deviation listing for correct and accurate deviation placement.Ensured that study startup activities were conducted and completed on time. These include preparing IRB/EC submission packages, creating and reviewing Informed consent forms, and reviewing the site and subject-facing documents and slides.Managed and implemented Study and Vendor escalations to meet studies demanding timelines.Maintained a solid knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country/Cluster personnelSupported the conduct of the study (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans) to ensure all operational study aspects were on trackEnsured recruitment targets were met by reviewing the process and strategy used by successful enrolling sites.Developed a newsletter to share site enrollment successes, strategies, and processes to help problem sites.Documented and reported vendor performance quarterly.Implement new patient engagement and recruitment processes during Covid 19 to achieve patient enrollment.Developed and adjusted study timelines, vendor budgets, and contracts to accommodate the constant changes caused by Covid 19Eagle Pharmaceuticals, Woodcliff Lake, Nj (In-house Contract) Jan-2017 Oct 2018Clinical Study Manager IIManaged a Phase 4 Respiratory study. This included one site in Mecca, Saudi Arabia.Ensured study activities were within projected timelines and determined course new and effect actions when needed.Supported Clinical Trial Teams in resolving issues relating to informed consent and IRB approval of clinical trialsConstantly enforced policies and procedures following GCP principles and sponsor SOPs to protect sponsors integrity.Reviewed CRA Visit Reports (IVM, RMV, COV) for accuracy, correctness, and needed action items.Data review of all EDC entries to identify discrepancies and determine if subjects mean the inclusion and exclusion criteria.Served as point of contact for internal and external audits of TMF-related processes and activitiesActively identified continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.Reviewed metrics to monitor performance against targets to ensure program deliverables are met, and productivity aligns with study expectationsApplied lessons learned to the continuous improvement of documentation management practices across study teamsDetermined and reviewed study-specific TMF specifications to ensure quality and standardization are established per program and kept up to date as program/protocols progressExecuted all action items within the time frame and escalated items to needed parties when neededAllergan Pharmaceuticals, Jersey City, NJ, (In-house Contract) Sept 2015 Dec 2016Clinical Trial ManagerManaged a significant Phase III IBS study with over 600 sites and 1500 subjects.Directly managed 2 CTA and 4 CRAs to support andVendor managed 3 to 4 vendors such as Lab, CRO, eDiary, and Drug Storage/Packaging/Shipping companies.Served as the primary contact for all protocol-related questions and quality/compliance issues and escalated queries to subject experts when necessaryManaged the development and amendment of Protocols, ICFs, and CSRs,Performed Clinical data review and protocol deviation review/evaluationAuthored Clinical sections of regulatory documents (IND annual reports/DSUR/PSUR, etc.)Managed clinical program timelines and budgets for assigned productsAuthored or provided Clinical input and review of study-related documents (vendor spec documents, patient-facing materials, site instructions, training materials, recruitment materials, user acceptance testing, etc.)Supported Clinical pre-approval inspection activitiesEnsured timely processing, validation, and quality transfer of clinical study data files from external sources to Sponsors.Met with CROs for Bid Defenses.Reviewed eDairy, Laboratory, and Central IRB's RFPs to meet the Study protocol needs and allocated budget.Reviewed and consolidated feedback from project team members for CRO and Vendor Selection.Requested Cost adjustment from Vendor's RFP due to changes and requests from Summited RFP.Provided direction and resolutions to vendor questions about the study protocol, processes, and plans.inVentiv Health Clinical, Princeton, NJ(Permanent) Jul 2010 Sep 2015CRA I to Sr CRA ( Remote )Managed a team of 4 CTAs, and 4 CRAs to complete a TMF remediation.Evaluated 3rd party vendors to provide Sponsor requested services.Managed Phase 1 and 2 respiratory medical devices for optinose.Reviewed Consent for the subjects ability to use the device and record usage on an eDiary.Managed 4 to 6 studies with about 20 to 30 sites.Developed robust SIV slides for SIV meetings ( including Study background, Study design, Key outcome, recruitment, lab, pharmacy, and more)Provided support to the team, ensuring they were aware of the responsibility and promptly performed their obligation.Performed audit and quality control checks on paper-based studies and Electronic Data Capture systems.Received, processed, and tracked all clinical project-related paper and electronic documents, including global study and site documentsBuilt an effective, high-performing TMF/eTMF team through a newly constructed task and focus management system.Created and maintained filing structure for all the regulatory INDs, NDAs, CTAs, DMFs, and SBAConducted site evaluation and feasibility assessments, including distributing and reviewing RFIs/RFPs and site questionnaires.Used SharePoint library to maintain consent templates and review tools for 70+ countriesPerformed site-startup activities, such as SIV, Site inspections.Conducted interim site visits to monitor protocol compliance.Performed SIV and COV for 5 to 8 allocated studies and 40 to 50 sites.GlaxoSmithKline (GSK), Parsippany, NJ (Permanent) Nov 2008-Sep 2010Data Analyst / Data EntryPerformed quality controls on entered data for data discrepanciesEntered and verified assay results in Clinical Lab Databases (ClinLab Direct Capture)Completed verification of data entries and cross-checked with Global Clinical sitesIdentified errors/inconsistencies in CRF data and ensured their resolutions in the Clinical DatabaseGenerated various study-related reports/listings to aid the cleaning of the database before database lock. |
