Manager, Laboratory Project Management - North Wales, PA
About the role
This vacancy has now expired. Please see similar roles below...
- Act as the Client's main contact in all matters regarding central laboratory services, following up and responding to study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and all internal Laboratory Departments.
- Review newly assigned Protocols and Amendments. Interpret the Client's Protocol into ILS terms and use this information to complete the Client Laboratory Worksheet (CLW) and communicate information as required to other departments within ILS (and ICON Clinical Research (ICR), if working on a jointly awarded study).
- Enter protocol parameter information into PACS/LIS/ICOLIMS systems for new and/or amended protocols. Prepare and QC clinical study specific materials.
- Responsible for preparing study specific presentation material and attending and representing ILS at Investigator Meetings, Kick-Off Meeting, Site Initiations, Lessons Learned and any other client meeting required.
- Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study specific Communication and Escalation Plan.
- Train Clients on ICOLabs and provide ongoing support in the use of this online results system.
- Define and add new tests and supplies into studies w with Client authorization.
- Proactively manage and track study progress, lab reporting or logistical issues, and perform risk management using a variety of internal management reports and the tools available.
- Provide Clients with regular study updates via a variety of reports from PACS, ICOLabs, the CRM and beyond, reporting and escalating trends, issues, or any deviations from the protocol either at the site level or internally. Forecasting and communicating study progress in a responsible and professional manner.
- Participates in teleconference/communication with Clients - either routine updates or discussion of specific issues.
- Manage issues escalated from Site Services and other internal groups, including problem-resolution, reporting trends, escalating outstanding queries and abnormal values to the Client and managing changes at database lock.
- Responsible for setting the timelines for and monitoring the progress of shipment requests for storage samples including data verification.
- Gathers and collates sponsor requested metrics.
- Interface with Business Development as needed for proactive monitoring of study budget.
- Responsible for documenting correspondence with all Clients and maintaining study specific files to ensure that all appropriate documents are properly maintained, ensuring all necessary documents are archived at study closure.
- Review new or updated SOPs as they are published to ensure they remain relevant, current and are being followed. Recommend policies, procedures and processes to ensure that a high level of QC and QA is maintained.
- Work to enhance team tools and practices by actively recommending suggest ions for improvements in efficiency and regular study progress to the Manager, PM.
- Draw from study management experience to recommend process improvements on best practices for communication and escalation and issue resolution.
- Provide feedback to the Business Development team regarding key clients
- Performs additional relevant responsibilities as requested by management
- Lead regular team meetings.
- Travel (approximately 20%) domestic and/or international
- Coach, mentor and develop direct reports. Delegate work to direct reports as appropriate.
- Evaluate the performance of direct reports and establish mutually agreeable goals and timelines.
- Coordinates the day to day on the job training of new Project Managers.
- Performs performance reviews, aids in goal setting and career development for team members.
- Approve/reject requests for Paid-Time-Off (PTO), Update labor tracking system(s) accordingly. Reconcile PTO.
- Hold a BS or BA in a Life Science or related field.
- You will possess a minimum of 5 working in a clinical laboratory, clinical trials, or customer management account management role in a life sciences related organization.
- At least 3 years of Project Management experience in a service area serving clinical trials, such as IVRS, Clinical Supplies Packaging and Distribution, Medical Imaging, Data Management , or Electronic Data Capture.
- At least 1 year of mentoring, supervising or leading other staff members.
- You will have working knowledge of MS Word, Excel and PowerPoint and possess the ability to multitask, remain composed and even-keeled in stressful situations, and perform effectively in spite of shifting priorities, workload and external pressures.
- Excellent Presentation Skills
- Organizational Agility
- Ability to work with, and maintain the confidentiality of customer proprietary information.
- Mastery in following established processes and use of all PM tools
- Knowledge and familiarity with the clinical trials industry.
- Ability to successfully perform job functions with little or no supervision.
- Ability to effectively apply learned principles to broader situations.
- Proven ability to proactively manage a broad variety of clinical studies
- Proven ability to utilize all resources and successfully navigate the organization for optimal study management
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Inclusion & BelongingContent type
BlogsPublish date
04/29/2024
Summary
Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how
Teaser label
IndustryContent type
BlogsPublish date
04/29/2024
Summary
Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi
Teaser label
Our PeopleContent type
BlogsPublish date
04/29/2024
Summary
Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o
Who we are
Similar jobs at ICON
Salary
Location
United States
Department
Biometrics Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
As a Project Data Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110193
Expiry date
01/01/0001
Author
Jeffrey VillasenorAuthor
Jeffrey VillasenorSalary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Site Activation
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own
Reference
JR118865
Expiry date
01/01/0001
Author
Olivia MolinaAuthor
Olivia MolinaSalary
Location
US, Raleigh, NC
Department
Full Service - Corporate Support
Location
Raleigh
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Intern
Job Type
Intern
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR118340
Expiry date
01/01/0001
Author
Mitzi OvertonAuthor
Mitzi OvertonSalary
Location
Regional United States (PRA)
Location
Montreal
Boston
Farmingdale
Multiple US Locations
Whitesboro
Burlington
Blue Bell
Rochester
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Biostatistician
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.Our ‘Own It
Reference
JR117634
Expiry date
01/01/0001
Author
Tallulah PierreAuthor
Tallulah PierreSalary
Location
US, Blue Bell (ICON)
Location
Raleigh
Blue Bell
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
Requirements:Must be located within the U.S.Must have 12+ months of independent monitoring experience as a CRAAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better
Reference
JR119530
Expiry date
01/01/0001
Author
Sarah WoodAuthor
Sarah WoodSalary
Location
Mexico, Mexico City
Location
Bogota
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Data Scientist Lead
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR118993
Expiry date
01/01/0001
Author
Tallulah PierreAuthor
Tallulah Pierre