This company is my LLC that can be utilized for 1099 contracts.

• Manage Three Oncology Clinical Trials: • Phase 1/1B Open-Label Multicenter, Two-Part Study, Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse large B-cell Lymphoma• Phase 1 Open-Label, Multi-Dose Two-Part Pharmacokinetics Study for Advanced Malignancies • Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trail, Drug-Drug Interaction as Frontline Therapy for Advanced Epithelioid Sarcoma• As clinical study lead, manage study execution, including management and oversight CROs, vendors and consultants that are involved with the clinical trial.• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.• Ensures risks are proactively identified, managed, and mitigation strategies implemented.• Ensure trial adherence to ICH-GCP, Federal and local regulations and company specific SOPs.• Oversees investigator recruitment/ selection.• Ensure study staff is appropriately trained on relevant guidelines, regulations, and SOPs.• Participate in program strategy meetings, ad hoc clinical operations’ initiatives, and programs.• Contribute to preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status updates.• Maintains primary responsibility for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, safety plans, project management plans, communication plans, and quality plans.• Review and provide input on clinical monitoring visit reports and ensure that all outstanding follow-up items are closed out in a timely manner.

• Manage Three Oncology Clinical Trials: • Phase 1/1B Open-Label Multicenter, Two-Part Study, Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse large B-cell Lymphoma• Phase 1 Open-Label, Multi-Dose Two-Part Pharmacokinetics Study for Advanced Malignancies • Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trail, Drug-Drug Interaction as Frontline Therapy for Advanced Epithelioid Sarcoma• As clinical study lead, manage study execution, including management and oversight CROs, vendors and consultants that are involved with the clinical trial.• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.• Ensures risks are proactively identified, managed, and mitigation strategies implemented.• Ensure trial adherence to ICH-GCP, Federal and local regulations and company specific SOPs.• Oversees investigator recruitment/ selection.• Ensure study staff is appropriately trained on relevant guidelines, regulations, and SOPs.• Participate in program strategy meetings, ad hoc clinical operations’ initiatives, and programs.• Contribute to preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status updates.• Maintains primary responsibility for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, safety plans, project management plans, communication plans, and quality plans.• Review and provide input on clinical monitoring visit reports and ensure that all outstanding follow-up items are closed out in a timely manner.

• Oversee Management of three Phase III Reproductive Health Clinical Trials• Leadership of the Clinical Team• Complete study tracking and report on study status.• Ensure study conduct in adherence to SOPs and study plans.• Perform data entry into the Clinical Trial Management System (CTMS).• Manage trial related documents in the Trial Master File and review documents for completeness, accuracy, and compliance with protocol and applicable regulations and standard operating procedures.• Oversee Vendors.• Manage Protocol Deviations and Violations.• Oversee Data Review and Cleaning activities.• Centralized Monitoring.• Audit/Inspection Communication and coordination of CAPA activities.• Participate in vendor and study team meetings. • Perform quality checks and follow-up on resolution of open issues to ensure cross functional study team members are compliant.• Create, Review, and Revise Study Plans.• Mentor and Train Study Team Members

Manage several multi-faceted projects, Auditors, and Consultants Globally.

Managed two, Phase III MS studies, one open label and other double blind. 10 Global Countries. Successfully managed 2CROs, 2 Vendors, and 2 Outside SME Consultants, and 1 Lab. Successfully completed database lock 2 months ahead of schedule for the Double-blind study. Conducted Cross-functional team meetings. Oversight of all monitoring activities, amendments, monitoring plans, KRI’s, Risk/Issues Plan and Log, participate in Inspection Readiness, interface with Legal, Logistics groups, Deputized for Clinical Operations Director. Support all Close out activities.

Supported Global Team Leader with conducting a 36 Global Country Study, Cardiovascular, Phase III.Executed and resolved a 3 year back log of PV/PDs for 36 Countries in 6 months. Tracked All Work through each step of the process and Interfaced with each Country Lead daily and regularly. Assisted wherever needed to conduct the trial successfully. A challenging yet rewarding experience in accomplishing all goals on time.

Monitored and Managed 3 main sites and co-monitored 3 other sites all on the east coast. PSSV, SIV, IMV, and COV's. Closely worked with the PI's and site staff. Issues queries through resolve to ensure clean data presented to the Sponsor company. Responsibilities were for 2 Phase III sister studies; one blinded one unblinded, for a Heroine study.

Monitor and Site Management for a Phase I Oncology Study, Phase II Pharmacodynamic study for Hypercholestorlemia, 2 Phase I Healthy Adult Volunteer studies, and Safety, Tolerability, and Bioeffect of Intravenously Administer study product in Health Volunteers.

Monitored a Phase III Global Oncology study for Carcinoid Syndrome - 100 subjects and Phase III Global non-functioning Entero-Pancreatic Endocrine Tumor Study - 200 patients. Managed 3 Clinical Research Associates, Co monitored, Oversight monitoring, Oversee the South American CRO, site management for 20 sites, 60% travel, Resolve Audits, Mentor CTA, Provide Training on Protocol, conduct of the study and any updates therein.

Project Manager of Phase IIa Diabetes Mellitus Study - 280 subjects, Phase I Cardiovascular, QTc Interval study and Finalize the CSR and TMF - 210 subjects/4 CohortsManage Phase III Chronic Kidney disease Study Global - 980 Subjects/123 Sites. Provide support to Phase III Hyperphosphatemea Study - SIVs, and team meetings. Lead remonitoring effort for high risk sites for the CKD study, assisted in hiring the 5 contract CRAs to assist in the remonitoring effort and managed them and their workload until complete. Provided training for the Contract CRA's. Filled in for the Clinical Trial Manager for 3 months until one employee was selected. Lead, Coordinated, and Managed 2 successful Patient Retention Meetings with the PI's, Sub-I's, SC's for 81 sites in the US, Mexico, and Canada and 78 sites in South America. Clinical Audits, Vender Management Process and Selection and RFP's.

Tasks were Vendor Management, Implemented medical outsourcing for US Medical Affairs Clinical Trial and Registry Work across all Therapeutic areas. Developed scope of work for multi-service, multi-vendor contracts with high degree of complexity and dollar value, Created and revised Change Orders, Developed Specification for the Execution of Agreements for Contract Research Services with Outside Vendors and CRS's, Monitor and Ensure Final Process of Outsourced work through to completion.

Provided sites with clinical support and resolution of study related issues - Mega trial - 800 sites for a Phase III Diabetes Mellitus study. Prepared Clinical Trial Study Documents. Liaised with the Regionally Based Field Monitors, CRS's and vendors. Assured data was collected according to the Novartis SOPs. Ensured project timelines were met by closely monitoring study activities and resources. Expedited Study Start-up, Safety - create, process, and track SAE Adjudication letters and send out to sites. Track enrolment and progress of each site. Coordinated all drug supply for distribution, track, and inventory in the IVRS system for 700 sites. Budget - Created and Reconciled tracking devise for investigator meeting expenses and deviations. Clinical Grant Payments and Reconciliation, Created and processed Study coordinator enrollment incentive program.