Medical Advisor/Associate Medical Director - Oncology/Hematology

IQVIA; Pasig; On-site; PHP 1,200,000 - 1,800,000; Full time

Job summary

IQVIA is seeking a Medical Advisor/Associate Medical Director to provide medical, clinical and scientific advisory expertise across clinical research studies, from protocol design to post-marketing considerations, and to support compliance from a medical perspective.

The role involves medical reviews of adverse events and trial documentation, training project teams, attending investigator meetings, and ensuring patient safety while collaborating with sites and cross-functional teams; willingness

Qualifications

• Medical degree with relevant clinical education in Hematology or Oncology.
• Board certification in a relevant specialty preferred.
• Experience in general clinical medicine and applicable medical specialty area.
• Knowledge of applicable federal and local regulations pertaining to clinical research.
• Strong communication and English language skills; ability to collaborate with teams.

Responsibilities

• Provide medical and scientific advisory support during study lifecycles and at investigative sites.
• Support protocol execution, clarifications, eligibility decisions and patient safety issues.
• Contribute to medical reviews of protocols, IDBs/CRFs and CSR documentation; review AEs/SAEs.
• Deliver therapeutic area training for project teams and present at investigator meetings.
• Coordinate with Pharmacovigilance for signal detection and adverse event reviews.

Skills

Regulatory knowledge

English proficiency

Communication skills

Travel willingness

Education

Medical degree

Hematology/Oncology specialty

Specialty Board certification

Job description

IQVIA is looking to appoint a Medical Advisor/Associate Medical Director to be part of our Medical Services team to deliver medical, clinical and scientific advisory expertise in clinical research studies. You will support compliance with protocol execution from a medical and scientific perspective. Also, you will provide medical expertise during project delivery lifecycles; provide medical support to project teams and investigative sites; clarify protocols and inclusion/exclusion determinations; advise around patient safety issues; perform medical reviews and clarifications of trial-related and post marketing studies Adverse Events; signal detection and aggregated reporting; and conducting project delivery lifecycles (pre-marketing and post-marketing).

Responsibilities

• Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects.
• 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.
• Contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
• Provide therapeutic area/indication training for the project clinical team.
• Attends and may present at Investigator Meetings.
• Performs review and clarification of trial-related Adverse Events (AEs).
• May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
• May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
• May perform medical review of adverse event coding.
• Performs review of the Clinical Study Report (CSR) and patient narratives.
• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
• Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.

Qualifications

• Medical degree with training in Hematology or Oncology from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
• Specialty Board certification in relevant specialty area preferred.
• Some years of prior relevant experience in general clinical medicine including experience in the requested applicable medical specialty area or equivalent combination of education, training, and experience.
• Current knowledge of medical, scientific and clinical landscape in applicable therapeutic area.
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
• Strong 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.
• May require occasional travel.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.

We appreciate your honesty and professionalism.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.