Independent Drug Monitoring, Manager

Role Overview:

The role will be responsible for unblinded drug management on a global scale. This includes facilitating the unmasked drug oversight (UDO) process as well as coordinating activities between the Independent Drug Monitoring Team and the global trial team. The role takes ownership of the drug oversight process to ensure key trial milestones are met and that processes are inspectionready and compliant with protocol requirements and regulatory guidelines. This position is also responsible for keeping the study team sites and all other applicable stakeholders well informed of drug monitoring progress and for communicating any compliance issues. Additional responsibilities include developing documentation and materials such as monitoring visit reports process documents and training materials for junior staff.

Responsibilities:

• Lead study teams in management of drug oversight processes and operations; ensuring blind is maintained.

• Provide input for the development of pharmacy related materials including forms and manuals.

• Support for system set-up of IVRS and EDC applications.

• Ensure adherence to quality of the UDO process/SOPs including documentation and escalation of major/critical issues in a blinded/masked manner; ensure issues are addressed and follow to closure.

• Monitor status of urgent/critical unblinded and pharmacy-related issues document said issues and investigate trends.

• Communicate with Trial Team on pharmacy-related compliance and ad hoc questions in a blinded/masked manner.

• Oversee Independent Drug Monitors (IDMs) to ensure investigational product activities are addressed at sites. Act as primary point of contact for the IDMs.

• Act as main point of contact for IDMs on study updates such as protocol amendments changes in timelines etc.

• Review IDM monitoring visit reports (initiation periodic & close-out) to ensure accuracy and timeliness; provide feedback and training as needed.

• Provide input in audits and/or CAPAs.

• Assist in database lock/interim analysis; cleaning unblinded data and reviewing unblinded queries if applicable.

• Maintain unblinded TMF and perform document management activities to ensure inspection readiness.

• Work proactively to increase global awareness of UDO processes; train and educate junior staff as well as stakeholders.

• Proactively contributes to process improvement initiatives at the global and site level.

Qualifications:

• Bachelors or University degree in appropriate scientific or business discipline.

  • Other equivalent related experience will be considered.

• 6 years of relevant experience in clinical trial operations pharmaceutical industry or equivalent related experience required.

• Proven track record in successfully managing various aspects of trials from start-up to database lock preferred.

• Must possess effective verbal written and presentation communication skills to work with a variety of stakeholders and drive change as needed.

• Must have strong working knowledge of the clinical trial process ICH-GCP local laws and regulations.

• Effective leadership skills and ability to manage teams and multiple stakeholders.

• Ability to independently make complex decision with limited information; ability to handle ambiguity.

• Candidates should display a proactive solution oriented approach to risk identification and mitigation.

• Experience in Project Management strongly preferred.

• Monitoring or pharmacy experience is preferred.

• Willingness to travel locally/domestically as needed.

• Previous work at a global level preferred.

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

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. 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.