Job Description

This service provides global coordination for the execution for unblinded drug management, including the general facilitation of the Independent Drug Monitoring process between the Independent Drug Monitoring Team (IDM Team) and the Global Trial Team. Ensure IDMM deliverables progress according to agreed upon timelines and in support of trial milestones; providing status updates, as required. Ensure inspection readiness through compliance with company Standard Operating Procedures (SOPs), codes of Good Clinical Practice (GCP), applicable other applicable regulations and guidelines from start-up through close-out. Takes ownership for assigned IDMM responsibilities.

Deliverables:

o Services rendered will adhere to applicable Sponsors SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.


o Comply with relevant and on-time training requirements.


o Lead study teams in management of IDMM related processes and operations; ensuring blind is maintained.


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


o System set-up including IVRS and EDC in a supportive capacity.


o Ensure adherence to quality of the IDMM process/SOPs, including, documentation, and escalation of major/critical issues in a blinded manner; follow up appropriately to closure.


o Act as the main point of contact for resolution of any ad-hoc questions associated with IDMM issues.


o Resolve and document urgent/critical unblinded and pharmacy-related issues and investigate trends.


o Monitor status and resolution of major/critical issues via Issue Logs and Visit Report review process.


o Provide updates to Trial Team on pharmacy-related and compliance issues in a blinded manner.


o Take initiative to suggest and implement solutions to site-level issues.


o Oversee Independent Drug Monitors (IDMs) to ensure investigational product activities are


addressed at sites. Act as primary point of contact for the IDMs.


o Provide communications and necessary information to IDMs on study updates, such as protocol amendments, changes in timelines, etc


o Review IDM monitoring visit reports (initiation, periodic & close-out) and provide feedback, as needed.


o Provide training and re-training to new IDMs and site pharmacy staff.


o Ensure IDM visits occur within window and ensure any out of window visits are tracked per process.


o Ensure IDM monitoring visit reports and issue logs are up to date.


o Ensure existence and accuracy of relevant IDMM process documentation, communication, and monitoring plans.


o Provide input in audits and/or CAPAs.


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


o Create appropriate trial specific IDMM training materials and requirements.


o Establish and maintain excellent working relationships with internal and external stakeholders.


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


o Provide feedback to and train/coach/guide junior colleagues as needed.


o Work proactively to increase global awareness of IDM processes; train and educate stakeholders.


o Comply with relevant and on-time training requirements.


o Contribute to IDMM process improvement and training, as applicable.


Education and Experience Requirements:


o Bachelor's or University degree; or equivalent related experience required, in appropriate scientific or business discipline. Other equivalent related experience will be considered, as deemed appropriate by hiring manager.


o 6 years of relevant experience in clinical trial operations in the pharmaceutical industry, CRO, or equivalent related experience required, as deemed appropriate by hiring manager.


o Experience in Project Management (mandatory for Advanced, preferred for Base).


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


o Previous work in an international environment preferred.


o Strong working knowledge of ICH-GCP, local laws and regulations.


o Effective leadership skills and ability to manage multiple stakeholders.


o Experience and ability in coordinating teams in a virtual environment.


o Proven ability to foster team productivity and cohesiveness.


o Independent complex decision making.


o Solution oriented and proactive risk identification and mitigation.


o Strong IT skills, including knowledge of standard Industry systems and Microsoft applications; willingness to learn new systems.


o Monitoring experience is recommended; other relevant experience will be considered.


o Willingness to travel locally/domestically.


o Proficient in speaking and writing local country language and English.


o Effective verbal and written communication skills.


o Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.


o Experience in developing presentations and presenting key information to stakeholders.

Please note

This role is not eligible for UK visa sponsorship

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