Manager of Clinical Sample Management - Home-Based

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Position Summary:

The Manager, Clinical Sample Management will oversee clinical sample life-cycle management, from multiple global clinical trials, internally and across external labs and third-party vendors.

The candidate will partner with Clinical Development Operations, Data Management, Clinical Development and Translational Medicine team members to build, implement and manage the end-to-end clinical PK and Biomarker sample logistics, both globally and locally, including oversight of lab vendor setup, tracking, collection materials (lab kits) and laboratory operational plans.

Essential Areas of Responsibility:

• Oversee clinical PK and Biomarker sample management and chain-of-custody in a GxP compliant setting, including sample processing, collection, storage, and distribution
• Share accountability for successful partnerships and workflows with central and third-party testing labs and storage facilities
• Manage lab kit design, assembly, storage, distribution and maintain adequate inventory to meet demands.
• Develop, process, and manage quotes and/or scope of work with business partners
• Manage and monitor sample transfer network and performance (metrics and key performance indicators) between clinical sites, central labs, and testing labs
• Oversee sample reconciliation across the network and resolve all sample discrepancies, including missing samples and label/data discrepancies
• Coordinate with partners to ensure the appropriate permits/licensure are established for lab kits to be shipped to clinical sites or for samples to be shipped to analytical labs
• Ensure all samples collected as part of protocol or outside of protocol are dispositioned
• Plan and coordinate clinical sample logistics with Clinical Operations, clinical sites, external labs, vendors, and couriers to ensure movement and sample processing timelines are met for on-time data transfer
• Oversee all operational activities required to ensure local and global high-quality sample processing, shipping, receiving, and short/long-term storage of samples
• Establish overall clinical lab sample accountability strategy across studies
• Support virtual or onsite training meetings, track and assemble training documentation and certifications
• Ensure completion, deployment and accuracy of the Clinical Sample Management Plan and associated laboratory/operational manuals
• Utilize tracking systems to report progress, address issues and resolution
• Represent sample management function at team meetings and prepare reports and presentations that provide transparency to key stakeholders
• Responsible for innovative sample management process improvement
• Provide input into clinical trial protocols/synopses and informed consent forms to ensure logistical feasibility of clinical sample strategy as well as alignment with all Clinical Sample Plans, ICH/GCP, and local regulations.
• Assist with budget, purchase order, and invoice tracking

Other Areas of Responsibility:

• Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations
• Identify best practices and benchmark other industry participants for use in assessment of internal capabilities and development of continuous improvement plans to ensure we are meeting or exceeding industry standards
• Build relationships and foster excellent collaboration and communication with internal and external stakeholders and partners
• Potential direct contact to CRA or Project managers
• Support Translational Medicine to provide information on timelines and other sample related technical and operational matters.
• Perform a variety of tasks, duties and responsibilities as assigned from time to time

Basic Qualifications and Minimum Education:

• Bachelor’s degree in life sciences or business major highly preferred with a minimum 12 years in life sciences industry related experience, can include Clinical Trials Management and/or Clinical Supply Management
• At least 6 years direct experience in clinical sample management environment and partnership oversight
• General knowledge of GMP, GCP, and GDP
• Experience in implementing and using sample management/tracking systems a plus
• Experience with oncology and neuroscience clinical trials is desirable
• Proficient knowledge of Microsoft Office (Outlook, Excel, Powerpoint and Project) required
• APICS certification (CPIM, CLTD, CSCP) a plus

Physical Demands and Work Environment:

• Travel domestic and international – up to 15%

Competencies:

• Demonstrated knowledge of clinical trial processes and designs (randomized, double-blind, double-dummy, placebo-controlled, cross-over, etc.)
• Demonstrated experience in inventory management and forecasting
• Demonstrated experience in international distribution, including knowledge of import/export licenses and customs operations
• Be a self-motivated team player and work effectively in a fast-faced environment to meet deadlines with a can-do attitude and persistent attention to detail
• Excellent communication, influencing, collaboration, and organizational skills, along with problem solving and conflict resolution
• Ability to multi-task and manage complexity
• Capability to provide a strategic vision and deliver operational excellence
• Respected by colleagues, key stakeholders, and business partners

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.