Clinical Reseach Manager of Oncology Studies.

Work as Clinical Team Manager in 3 Phase 3 multi-center oncology clinical trials • Manage the execution of project deliverables within contractual timelines and client expectations through all active phases (; maintenance; closeout-database lock) of a trial• Manage clinical resources (CRAs/administrative team) according to projections of ongoing clinical activities to ensure maximum resources are allocated to maintain forward movement of clinical deliverables• Manage clinical budget; escalate out-of-scope activities to the appropriate individuals for inclusion in a contract modification• Track, review, and distribute metric updates (regulatory, enrollment, CRF retrieval, subject visits, query, etc.) to external/internal clients/vendors• Manage contingency planning for data cleaning; clinical data listings review; and, coordinate process for reviewing data listings by clinical team • Responsible for the implementation and training of standardized clinical monitoring processes within the study team• Participate in site recruitment and budget negotiations• Provide leadership, coordination, and management of the PPD-customer joint project team through start-up, conduct, tracking, quality, and regulatory compliance management and close-out activities• Perform review of pass-thru travel costs to ensure the most cost-effective travel practices are being utilized by monitoring staff• Perform review of trip reports of team CRAs to ensure monitoring activities are appropriately conducted and documented for the client according the contractual obligations• Review essential regulatory documents prior to transmittal to the client for release of initial investigational product• Presentation at Investigator Meetings• Responsible for coordinating and managing all team activities for the trial;• Direct technical and operational aspects of the project to ensure compliance with FDA regulations and PPD Procedures

Work as monitor in multi-center clinical trials on Oncology (Breast Cancer) and Circulatory.• Perform all duties of a CRA as listed in job title below, serving as the primary contact with individual investigative sites that conduct clinical research for PPD• Track enrollment status reports to ensure study stays on track to meet enrollment goals• Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status were kept current by the monitoring team• Perform Serious Adverse Event reconciliation and work with sponsor, study sites and CRAs to resolve discrepancies• Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines• Attend sponsor calls and internal team calls to stay informed of current study issues• Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.• Conduct site visits to determine protocol and regulatory compliance, and prepared required documentation• Develop collaborative relationships with investigative sites, client company personnel and study vendors

Work as monitor in multi-center clinical trials on Oncology (Prostate and Breast Cancer), Endocrine / Metabolic and Circulatory.• Perform all duties of a CRA as listed in job title below, serving as the primary contact with individual investigative sites that conduct clinical research for PPD• Track enrollment status reports to ensure study stays on track to meet enrollment goals• Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status were kept current by the monitoring team• Perform Serious Adverse Event reconciliation and work with sponsor, study sites and CRAs to resolve discrepancies• Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines• Attend sponsor calls and internal team calls to stay informed of current study issues• Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.• Conduct site visits to determine protocol and regulatory compliance, and prepared required documentation• Develop collaborative relationships with investigative sites, client company personnel and study vendors

Worked as monitor in multi-center clinical trials on Oncology (Phase III trials of Breast Cancer and Gastric Cancer) and Nephrology (International phase III trial of Chronic kidney Disease). •Performed budget negotiation with Investigators;• Prepared the financial agreements for study sites and vendors, collecting all signatures to study viability;• Ensured essential documents are collected, reviewed and tracked;• Participation in Investigator’s Meeting;• Performed pre-study, initiation and monitoring visits;• Conduction of trainings for study sites.

Worked as monitor in multi-center clinical trials on Oncology (Phase III trials of Breast Cancer and Lung Cancer), Rheumatology (Phase III trial of Rheumatoid Arthritis) and Dermatology (Phase III trial of Psoriasis). • Performed budget negotiation with Investigators;• Prepared the financial agreements for study sites and vendors, collecting all signatures to study viability;• Ensured essential documents are collected, reviewed and tracked, regulatory documentation dossier preparation to Health Authorities and IRB submission;• Participation in Investigator’s Meeting;• Performed pre-study, initiation, monitoring and close-out visits;• Conduction of trainings for study sites.

Worked as monitor in multi-center clinical trials on Oncology (Phase III trials of Breast Cancer and Lung Cancer) and Rheumatology (Phase III trial of Rheumatoid Arthritis).• Performed Regulatory activities;• Ensured essential documents are collected, reviewed and tracked, regulatory documentation dossier preparation to Health Authorities and IRB submission;• Performed initiation and monitoring visits;• Conduction of trainings for study sites.

Worked as monitor on two international phase III trials of Breast cancer and one international phase III trial to compare the analgesic efficiency in renal colic. • Performed Regulatory activities;• Ensured essential documents are collected, reviewed and tracked, regulatory documentation dossier preparation to Health Authorities and IRB submission;• Performed initiation and monitoring visits.