The Clinical Biomarker Specimen Specialist works collaboratively with the Clinical Biomarker Operations Manager, Study Managers, and Scientific stakeholders to ensure timely and smooth collection, transfer, and testing of clinical trial specimens. This role will ensure full chain of custody is maintained through the specimen lifecycle from collection through testing and final sample disposition. This role requires clinical study, specimen management, and project management experience. As well as knowledge of GxP and vendor-sponsor best practices.

Key Accountabilities:

Oversight of programming activities:

• Clinical specimen management from collection through testing and final disposition

• Ensures compliance with clinical protocol and informed consent.

• Maintain chain of custody for specimens

• Organize and oversee the collection, shipping and proper storage and maintenance of clinical specimens

• Resolve and/or triage specimen queries from sites or vendors

• Ensuring proper documentation of specimen destructions are obtained and filed appropriately

Collaborative relationships:

• Collaborate on implementation and maintenance of specimen tracking system

• Work collaboratively with internal key stakeholders (e.g. Project Management, Clinical Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to ensure proper alignment and study-level execution of specimen management

Compliance with Parexel standards:

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• Effective project management and time management skills; able to prioritize successfully

• Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession

• Detail oriented; performs quality and accurate work with minimal oversight

• Excellent written/verbal communication skills

• Can identify opportunities for efficiency improvements and simplification, recognizes appropriate.

• Resources for deliverables, has effective organizational skills

• Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively

• Flexible, easily adapts to change, and is energized by challenges and problem-solving

• Can learn new skills and knowledge, able to offer new ideas but also willing to adapt style to existing process as appropriate

• Other competencies include managing complexity and ambiguity, decision quality, collaborates, cultivates innovation, customer focus, nimble learning, balances stakeholders, and action oriented

• Proficiency in written and spoken English – required

• Proficiency in local languages (as applicable)

Knowledge and Experience:

• Years of experience: 2-5 years; dependent on level of related skills and education

• Laboratory background and/or strong knowledge of commonly tested biomarkers in the Oncology setting, latest and advanced analytical tools and assays

• Proficiency with data sets and Excel, understanding of data relationships and metadata

• Confident in overseeing vendors and communicating with experts to drive quality deliverables

• Preferred:

• Previous biobanking, sample tracking and handling experience

• Previous LIMS (Laboratory Information Management System) experience

• Working knowledge of the clinical drug development process

• Working knowledge of the Food & Drug Administration (FDA) regulations, International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines, Study Data Tabulation Model (SDTM), Clinical Data Interchange Standards Consortium (CDISC), database development and User Acceptance Testing (UAT).

• Oncology experience and/or working knowledge

• Proficiency with timeline management

Education:

• Bachelor of Arts/Bachelor of Science in relevant field, or other relevant experience/qualification