Associate Medical Director- Oncology ,Sponsor-Dedicated (m/w/d)
IQVIA
_The Study Physician is a critical global role responsible for assuming medical oversight of clinical trials within Clinical Development & Operations. This position requires a qualified and clinically experienced physician who will provide comprehensive medical expertise throughout all phases of the trial—from preparation and conduct to reporting. The Study Physician ensures state-of-the-art medical oversight from the Trial Design Outline (TDO) kickoff through to the Clinical Trial Report (CTR) and serves as a core member of both the Trial Team and the Evidence Network Team._
**_Study Physician services_**
_Medical Content Oversight:_
+ _Responsible for medical content in Clinical Trial Protocols (CTPs)._
+ _Collaborates with Project Management, Patient Safety, Medical Writers, and trial/evidence teams._
+ _Provides medical input for CTP updates._
_Risk-Based Quality Management_ _:_
+ _Defines medically critical data/processes and associated risks._
+ _Contributes to Integrated Quality and Risk Management Plan (IQRMP)._
+ _Participates in risk discussions during trial conduct._
_Clinical Quality Monitoring_ _:_
+ _Co-authors Clinical Quality Monitoring Plan (CQMP)._
+ _Aligns CQMP with IQRMP-identified risks and mitigations._
_Protocol Deviations Management_ _:_
+ _Provides medical input on important protocol deviations (iPDs)._
+ _Reviews and supports decisions on iPDs using advanced systems._
_Clinical Quality Communication_ _:_
+ _Proactively addresses and communicates clinical quality issues._
_Trial Documentation and Milestones_ _:_
+ _Contributes to timely preparation of core trial documents and milestones._
_Data Management Input_ _:_
+ _Designs eCRFs and translates medical questions into electronic data capture._
+ _Develops “Information for CRF Completion” (ICC) and Data Review Plans._
+ _Specifies lab parameters and contributes to Data Transfer Agreements and alerts._
_Patient-Facing and Trial-Level Documents_ _:_
_Responsible for medical content in Patient Information and Informed Consent, Trial Monitoring Manual, Communication and Training Plans and Trial Statistical Analysis Plan (TSAP)_
_Reporting and Narratives_ _:_
+ _Contributes to Patient Narrative preparation._
+ _Participates in planning and reviewing medical sections of Clinical Trial Reports._
_Qualifications_
_Medical degree from an accredited and internationally recognized medical school._
_Typically requires a minimum of 5-7 years' experience in clinical medicine._
_Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area._
_Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research._
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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
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.
EEO Minorities/Females/Protected Veterans/Disabled
Confirmar seu email: Enviar Email
Todos os Empregos de IQVIA