IQVIA
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This is a Remote Role
Job Overview
Provides medical, clinical and scientific advisory expertise to all IQVIA divisions, as requested. May serve as medical expert during project delivery lifecycle. Provides leadership, management and direction to assigned staff. Assists in the implementation of department mission, goals and objectives.
Essential Functions
- May act as Therapeutic Medical Adviser on assigned projects, performing medical monitoring services.;
- Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations and issues of patient safety and/or eligibility.;
- May contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).;
- May provide therapeutic area/indication training for the project clinical team.;
- May attend and present at Investigator Meetings.;
- May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.;
- May oversee/perform medical review of coding, listings and patient profiles.;
- May perform review of the Clinical Study Report (CSR) and patient narratives.;
- May attend project Kick-Off meetings, weekly team meetings and client meetings, as needed or requested.;
- May provide out of hours medical monitoring service to respond to urgent protocol-related issues at the investigative sites.;
- May provide strategic, medical and budgeting input into proposal development including participation at BD meetings.;
- Provides Line Management of Regional /Multiregional staff and may serve as Regional/Multiregional Therapeutic Area Head.;
- Ensures that departmental mission, goals, objectives, policies, processes and standard operating procedures are communicated, understood and implemented by assigned staff.;
- Manage staff in accordance with organization’s policies and applicable regulations.;
- Responsibilities include planning, assigning, and directing work, appraising performance, mentoring and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems.;
- Supervises Medical Services and recommends course of action on management/human resources matters, including salary administration, transfers, hiring, terminations, training and professional development.;
- Continually reviews assigned staff workload and volume projections and makes sure adequate resources are available to meet deliverables timelines and quality requirements.;
- Ensure appropriate balance of project assignments for direct reports.;
- Participates at management level meetings.;
- Maintains awareness of industry development and may author related publications.;
- May require up to 25% travel (domestic and international);
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech;
- Extensive use of keyboard requiring repetitive motion of fingers;
- Regular sitting for extended periods of time;
Qualifications
- Other Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
- Other Specialty Board certification in relevant specialty area preferred Pref
- Typically requires 5 – 7 years of prior relevant experience in general clinical medicine including experience in the requested applicable medical specialty area;
In addition, previous clinical research experience as an investigator or in the Pharma, CRO, or Biotech industry is required;
or equivalent combination of education, training and experience Req
- Current knowledge of medical, scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.;
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.;
- Good communication, presentation and interpersonal skills, including good command of English language (both written and spoken).;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.;
- Skills in providing consultation and advice on multiple assignments are required as well as initiative and flexibility.;
- Current and valid country/state medical license or equivalent, from the country or region in which he/she resides and works;
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
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