Biomarker Sample Operations Lead

Job Overview 

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Biomarker Sample Operations Lead. This role will oversee clinical sample life-cycle management, from multiple global clinical trials, internally and across external labs and third-party vendors. This position will report to the Executive Director, Data Management.  

The candidate will partner with Clinical 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. The candidate will ensure that the PK and Biomarker analysis samples are accurately acquired, processed, and prepared for contracted laboratory analysis.  The responsibility spans from the initial operationalization of the clinical protocol through site-facing instructional documentation to the delivery of precisely processed samples to the final analysis lab. The work will come through global and local implementation, including collaboration with large central and more specialized analysis lab vendors for study setup, sample monitoring, and eventual data reporting per data transfer agreement development.   

Job Duties and Responsibilities 

• Oversee clinical PK and Biomarker sample management and chain-of-custody in a GxP compliant setting, including sample processing, collection, storage, and distribution. 

• Contributes to the accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, logistics and shipping as needed  

• Contributes to generation of study related training for the study team, study sites and vendors for each trial. This may include development of site qualification requirements for sample processing or conduct of site facing training on sample collection procedures.  

• Develops site facing instructions (e.g., Lab Manual) to ensure accurate PK & Biomarker sample collection and processing at sites. 

• Coordinate sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct database. 

• Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices and ethical guidelines 

• Participate in implementation of technologies/tracking solutions that ensure sample chain of custody and data integrity.  

• 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 programs and resolve all sample discrepancies, including missing samples and label/data discrepancies in collaboration with cross functional teams. 

• 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 

• 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 Biomarker & PK sample analysis plans, ICH/GCP, and local regulations. 

• 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 

Key Core Competencies 

• Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing, dynamic company. 

• Excellent communication, influencing, collaboration, and organizational skills, along with problem solving and conflict resolution 

• Ability to develop and deliver training materials to achieve team understanding of projects and enable effective delivery.  

• Ability to multi-task and manage complexity 

• 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 

• 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 

• Capability to provide a strategic vision and deliver operational excellence 

 Education and Experience 

• Bachelor’s degree in life sciences or business major highly preferred with a minimum 6 years in life sciences industry related experience, can include Clinical Trials Management and/or Clinical Supply Management 

• At least 2 years direct experience in clinical sample management environment and partnership oversight 

• General knowledge of GCP, GLP and CAP/CLIA requirements 

• Experience in implementing and using sample management/tracking systems a plus 

• Must be able to travel to the corporate location as needed. 

• Experience with oncology clinical trials is desirable 

• Proficient knowledge of Microsoft Office (Outlook, Excel, PowerPoint and Project) required 

• APICS certification (CPIM, CLTD, CSCP) a plus 

• Regularly required to sit for extended periods of time and occasionally stand and walk. 

• Regularly required to use hands to operate computer and other office equipment. 

• Close vision required for computer usage. 

The base salary range for this role is $112,300 to $140,400.  Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.