Bioanalytical Project Manager - Gaithersburg, MD

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development as a Bioanalytical Project Manager

What you will be doing: 

• Project manage clinical bioanalysis studies at bioanalytical partner labs and ensure delivery of key study data on time and to quality standards.
• Manage contracting with third-party lab service providers for assay development and validation, and work with business operations, procurement, and clinical operations to ensure appropriate SOWs and contracts are put in place for sample analysis of clinical trials samples.
• Coordinate with bioanalytical strategy leads, clinical trial teams and third-party lab service providers to review, edit, and finalize study documents for delivery of the required lab services and ensure study timelines are met.
• Provide input into clinical trial related documentation such eCRFs, ICFs, SOWs, sample collection instructions.
• Work with data BSLs, data management, programmers to drive delivery of data transfer specifications and the associated data.
• Manage sample tracking and logistics for sample testing, contribute to any sample reconciliation issues, including flow cytometry samples.
• Coordinate with internal and external stakeholders to ensure delivery and adequate inventory of reference standards, critical reagents, and other necessary materials for bioanalytical studies Address issues that arise in data transfers and drive cleaning and reconciliation of the data for data finalization.
• Develop and maintain clinical study dashboard to forecast and provide study progress to internal and external stakeholders.
• Additional opportunities to contribute to scientific interpretation of data commensurate with experience and ability.

You are: 

• BA/BS or higher degree with a background in medical science or relevant scientific background
• Demonstrated experience (5-7) in developing/validating bioanalytical and/or biomarker assays to support clinical trials (PK, ADA, Nab assays and biomarkers)
• Familiar with clinical bioanalysis outsourcing operations across a range of technology platforms, including real-time Flow Cytometry
• Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and AstraZeneca expectations.
• Experienced in GLP, GCP guidelines and environment, vendor audits.
• Familiar with clinical trials design with an ability to read a clinical study protocol and understand the study design and data outputs (i.e., dosing regimen, cohort requirements, secondary and exploratory data outputs, schedule of assessments etc.)
• Experienced in handling and providing sample collection instructions and review and provide input into lab manuals regarding sample collections.                  
• Familiar with data transfer agreement/specifications
• Basic understanding of reconciliation (sample and data)/cleaning of clinical data and generating queries for resolution
• Ability to support project resourcing and project timeline planning, negotiation with CROs and stake holders on timelines to gain alignment, and adherence to timelines.
• Good written/ verbal communication skills with a strong command of English language and grammar; excellent organizational, analytical/problem solving skills and attention to detail
• Strong interpersonal communication skills and the ability to work and collaborate effectively on cross-functional teams
• Ability to work productively in both a team environment and independently as needed
• Proficiency with Excel and/ or other interactive computer programs

What ICON can offer you: 

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. 

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.  

Our benefits examples include: 

• Various annual leave entitlements 

• A range of health insurance offerings to suit you and your family’s needs 

• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead 

• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being 

• Life assurance 

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others 

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits 

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people,  patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON  is committed to providing a workplace free of discrimination and harassment.  All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.  If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through this form.