Ref #: 28572

Employment type: Permanent - Full-Time

Location: US-NY-New York City

Posted: 12-Mar-2021

Description

Independent Drug Monitoring Manager (IDM Manager)

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them? Consider joining our team!

At ICON DOCS, we have an incredible, home-based, opportunity for expert Independent Drug Monitoring Managers to join the team in the US.

Position Overview:

DOCS is currently seeking, home-based, Independent Drug Monitoring Managers (IDM Managers) for the US. This service provides global coordination for the execution for unblinded drug management, including general facilitation of the Independent Drug Monitoring process between the Independent Drug Monitoring Team (IDM Team) and the Clinical Trial Team. The IDM Manager will ensure IDM deliverables progress according to agreed upon timelines and in support of trial milestones. The IDM Manager also ensure inspection readiness through compliance with company Standard Operating Procedures (SOPs), codes of Good Clinical Practice (GCP), other applicable regulations and guidelines from start-up through closeout.

Position Responsibilities:
• Lead study teams in management of IDM related processes and operations, ensuring blind.
• Provide updates to Trial Team on pharmacy-related and compliance issues in a blinded fashion.
• Ensure adherence to quality of the IDM process, including translation, 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 IDM issues.
• Oversees Independent Drug Monitors (IDMs) to ensure investigational product activities are addressed at sites.
• System set-up including IVRS and EDC in a supportive capacity.
• Resolve and document urgent/critical unblinded and pharmacy-related issues and investigate trends
• Provide communication and necessary information to IDMs on study updates, such as protocol amendments; potential to co-monitor IDMs.
• Review IDM monitoring visit reports (initiation, periodic & closeout) and provide feedback, as needed.
• Assist in database lock/interim analysis; cleaning unblinded data and reviewing unblinded queries, if applicable
• Monitor status and resolution of major/critical issues via Issue Logs and Visit Report review process
• Ensure existence and accuracy of relevant DM process documentation, communication and monitoring plans.
• Ensure IDM visits occur within window and ensure any out of the window visits are tracked per process.
• Maintain Blinded TMF and perform document management activities.

Position Requirements:
• Bachelor’s Degree, in appropriate scientific or business discipline
• 3-5 years of relevant experience in clinical trial operations, within the pharmaceutical industry or CRO
• Project Management experience is mandatory, as well as knowledge of databases and/or project management systems
• Willingness to travel locally/domestically
• Experience working in an international environment is essential
• Effective leadership skills and ability to manage multiple stakeholders
• Experience in developing presentations and presenting key information to stakeholders

Why join us?
Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

Ongoing development is vital to us, and as an IDM Manager, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.




#UnblindedDrugManagement #GlobalClinicalTrials