IQVIA Argentina
Senior Medical Director, Oncology/Hematology
IQVIA Argentina, Durham, North Carolina, United States, 27703
Overview
The Senior Medical Director is a team member participant role functioning in a matrix to project teams. The primary role is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The Medical Monitor serves as the primary contact for the sponsor medical team and as a frontline medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Essential Functions
Functions as project team member Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory submissions, serious and non-serious adverse event evaluation and reporting Ensures medical activities run according to GCP and operate with high efficiency Establishes and maintains a network of medical/scientific consultants Supervises and manages Medical Director activities Clinical Activities
Interacts with clients regarding drug development programs, study design and protocol Reviews and provides input for protocol development; interacts with key thought leaders and sponsor representatives to develop inclusion/exclusion criteria and study endpoints; collaborates on statistical and data management sections of the protocol; reviews the final protocol for clinical, safety and efficacy variables Provides project team training on protocol and therapeutic areas Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation Participates in subject recruitment and retention activities including calls to key opinion leaders, investigators and site staff and/or participation in teleconferences and WebEx presentations Presents protocol and/or safety reporting information at investigator meetings Develops project medical monitoring plans as requested Provides on-call coverage for protocol queries and site support; serves as first line contact for investigators and monitors regarding study-related medical/safety issues and resolution of protocol and patient eligibility issues Safety Monitoring and SAE Reporting Activities
Verifies the medical accuracy of patient safety data and maintains ongoing assessment of the study safety profile Provides medical review of SAE reporting, writes/ reviews SAE narratives, and coordinates with the Safety Management Department to track SAEs and follow up on outstanding safety queries; interacts with sponsor and discusses safety issues with sites as needed Reviews IND/SUSAR safety reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data In consultation with the sponsor, follows procedures for acquiring knowledge of subject treatment assignments (e.g., breaking the blind) Interacts with appropriate FDA officials concerning safety and other study-related issues, as requested Data Activities
Provides medical review of eCRFs for clinical accuracy Provides medical review of data analysis plan Reviews safety fields at case freeze for reconciliation (if needed) Works with data group to reconcile SAE events as needed Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends Reviews data tables, listings, and figures Reviews and/or writes portions of the final clinical study report DSMB/Adjudication Committee Activities
May assist sponsor in choosing committee members May serve as a non-voting member to convene and organize proceedings May develop operating guidelines in conjunction with committee members and submit these to sponsor for review May determine data flow with sponsor to ensure reporting accuracy Can ensure DSMB feedback is given to sites for IRBs All DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical monitor Business Development Activities
Work with Business Development to actively solicit new business, including assistance with marketing presentations and proposal development Supports business development activities with proposal development and sales presentations Participates in feasibility discussions relating to specific project proposals Special Projects
Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc. Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities Participate in a variety of team quality improvement efforts as necessary Perform other related duties as assigned or requested by the Chief Medical Officer Qualifications
Minimum 3-5 years of biopharmaceutical industry experience or academic experience in clinical research and drug development Current or prior license to practice medicine; board certification/eligibility ideal in Hematology/Oncology Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus Outstanding ability to work independently with minimal supervision, ability to work effectively within a team and matrix environment Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities Excellent oral and written communications skills as well as interpersonal skills are essential IQVIA is a leading global provider of clinical research services and healthcare insights. We create intelligent connections to accelerate the development and commercialization of medical treatments to help improve patient outcomes and population health. Learn more at the IQVIA website IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
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The Senior Medical Director is a team member participant role functioning in a matrix to project teams. The primary role is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The Medical Monitor serves as the primary contact for the sponsor medical team and as a frontline medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Essential Functions
Functions as project team member Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory submissions, serious and non-serious adverse event evaluation and reporting Ensures medical activities run according to GCP and operate with high efficiency Establishes and maintains a network of medical/scientific consultants Supervises and manages Medical Director activities Clinical Activities
Interacts with clients regarding drug development programs, study design and protocol Reviews and provides input for protocol development; interacts with key thought leaders and sponsor representatives to develop inclusion/exclusion criteria and study endpoints; collaborates on statistical and data management sections of the protocol; reviews the final protocol for clinical, safety and efficacy variables Provides project team training on protocol and therapeutic areas Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation Participates in subject recruitment and retention activities including calls to key opinion leaders, investigators and site staff and/or participation in teleconferences and WebEx presentations Presents protocol and/or safety reporting information at investigator meetings Develops project medical monitoring plans as requested Provides on-call coverage for protocol queries and site support; serves as first line contact for investigators and monitors regarding study-related medical/safety issues and resolution of protocol and patient eligibility issues Safety Monitoring and SAE Reporting Activities
Verifies the medical accuracy of patient safety data and maintains ongoing assessment of the study safety profile Provides medical review of SAE reporting, writes/ reviews SAE narratives, and coordinates with the Safety Management Department to track SAEs and follow up on outstanding safety queries; interacts with sponsor and discusses safety issues with sites as needed Reviews IND/SUSAR safety reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data In consultation with the sponsor, follows procedures for acquiring knowledge of subject treatment assignments (e.g., breaking the blind) Interacts with appropriate FDA officials concerning safety and other study-related issues, as requested Data Activities
Provides medical review of eCRFs for clinical accuracy Provides medical review of data analysis plan Reviews safety fields at case freeze for reconciliation (if needed) Works with data group to reconcile SAE events as needed Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends Reviews data tables, listings, and figures Reviews and/or writes portions of the final clinical study report DSMB/Adjudication Committee Activities
May assist sponsor in choosing committee members May serve as a non-voting member to convene and organize proceedings May develop operating guidelines in conjunction with committee members and submit these to sponsor for review May determine data flow with sponsor to ensure reporting accuracy Can ensure DSMB feedback is given to sites for IRBs All DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical monitor Business Development Activities
Work with Business Development to actively solicit new business, including assistance with marketing presentations and proposal development Supports business development activities with proposal development and sales presentations Participates in feasibility discussions relating to specific project proposals Special Projects
Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc. Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities Participate in a variety of team quality improvement efforts as necessary Perform other related duties as assigned or requested by the Chief Medical Officer Qualifications
Minimum 3-5 years of biopharmaceutical industry experience or academic experience in clinical research and drug development Current or prior license to practice medicine; board certification/eligibility ideal in Hematology/Oncology Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus Outstanding ability to work independently with minimal supervision, ability to work effectively within a team and matrix environment Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities Excellent oral and written communications skills as well as interpersonal skills are essential IQVIA is a leading global provider of clinical research services and healthcare insights. We create intelligent connections to accelerate the development and commercialization of medical treatments to help improve patient outcomes and population health. Learn more at the IQVIA website IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
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