Independent Drug Monitoring, Manager

IQVIA•Parsippany, NJ

About The Position

Role Overview: The role will be responsible for independent drug monitoring for assigned studies. This responsibility will include end to end ownership for the trial, from the initial set up and drug blinding activities, to ongoing monitoring of studies, and any duties needed for the successful closure of said trials. This role will escalate any issues found during monitoring and will work to resolve said issues. This role will be responsible for keeping the study team, sites, and all other applicable stakeholders well informed of the progress of drug monitoring as well as communicating any compliance issues. Further duties include developing documents and materials included monitoring visit reports, process documents, and training materials for junior staff.

Requirements

Bachelor’s or University degree; or equivalent related experience required, in appropriate scientific or business discipline.
6 years of relevant experience in clinical trial operations in the pharmaceutical industry, CRO, or equivalent related experience required.
Strong working knowledge of ICH-GCP, local laws and regulations.
Effective leadership skills and ability to communicate with and manage multiple stakeholders.
Experience and ability in coordinate and foster productivity of teams in a virtual environment.
Solution oriented and ability to take ownership of work to proactively identify risks and mitigate their impact.
Strong IT skills, including knowledge of standard Industry systems and standard systems.
Willingness to travel locally/domestically.
Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
Experience in developing presentations and presenting key information to stakeholders.

Nice To Haves

Experience in Project Management, preferred.
Proven track record in successfully managing various aspects of trials from start-up to study closure and database lock, preferred.
Previous work in global trials, preferred.
Monitoring experience is recommended; other relevant experience will be considered.

Responsibilities

Lead study teams in management of Independent Drug Monitoring related processes and operations; ensuring blind is maintained.
Provide input for the development of pharmacy related materials, including forms and manuals.
System set-up including IVRS and EDC in a supportive capacity.
Responsible for quality of and adherence to SOPs, including, documentation, and escalation of major/critical issues in a blinded manner; follow up appropriately to closure.
Act as the main point of contact for resolution of any ad-hoc questions associated with drug monitoring issues.
Resolve, monitor, and document urgent/critical unblinded and pharmacy-related issues and investigate trends.
Provide updates to Trial Team on pharmacy-related and compliance issues in a blinded manner.
Take initiative to suggest and implement solutions to site-level issues.
Oversee Independent Drug Monitors (IDMs) to ensure investigational product activities are addressed at sites. Act as primary point of contact for the IDMs.
Provide communications and necessary information to IDMs on study updates, such as protocol amendments, changes in timelines, etc
Review independent drug monitoring visit reports (initiation, periodic & close-out) and provide feedback and ensure that visit reports and issue logs are up to date.
Ensure existence and accuracy of relevant IDMM process documentation, communication, and monitoring plans.
Provide input in audits and/or CAPAs.
Assist in database lock/interim analysis; cleaning unblinded data and reviewing unblinded queries, if applicable.
Create appropriate trial specific IDMM training materials and requirements as well as mentoring and training junior colleagues, as needed.
Establish and maintain excellent working relationships with internal and external stakeholders.
Maintain unblinded TMF and perform document management activities to ensure inspection readiness.
Contribute to IDMM process improvement, as applicable.