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.
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.
Qualifications:
• 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.
• 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.
• 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.
• Monitoring experience is recommended; other relevant experience will be considered.
• 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.
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 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. https://jobs.iqvia.com/eoe
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.
The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.iqvia