General Description:
Manage biomarker related operational part for clinical trials and oversee and manage the performance of junior project managers
Essential Functions of the job:
Independently manage biomarker and bio-sample testing activities for clinical trials, including but not limited to review and finalize lab vendors key documents (such as lab manual, lab database design documents, contracts & budget, etc. ) , track bio-specimens, schedule and execute bio-specimen testing based on study needs, oversee lab vendor performance and provide biomarker related expertise for clinical trials conduction from an operational perspective.
Collaborate and communicate with internal functional stakeholders including biomarker scientists, clinical operations and others, to drive the biomarker related works for clinical trials, such as manage lab vendors timeline, control biomarker budget, ensure compliance and quality, etc.
Collaborate with internal to review key study documents such as ICF, EDC design specification, IRC integration specification, etc. and provide training to investigator sites as needed for sample collection schedule, sample processing and shipment, etc.
Participate in clinical study team meetings, providing updates and insights related to biomarker activities and progress
Have a good knowledge of CDx regulations and manage three-way communications with both device partners and lab vendors to make sure biomarker strategy and CDx strategy is implemented
Oversee junior project managers' work and performance.
Supervisory Responsibilities:
Provide training and coaching to project coordinators, junior project managers
Manage project coordinators/junior project managers performance
Computer Skills: Proficient in MS office
Other Qualifications:
Bachelor or above in biology/medical major.
At least 7 years project management experience
Experience in the pharmaceutical industry and/or academia is preferred
Understanding of scientific concepts and experience in translational research and oncology biomarker development.
Proven organizational and project management skills and the ability to manage cross-functional efforts.
Ability to work effectively on multiple oncology programs in a fast-paced, dynamic environment
Excellent verbal and written English communication skills
Have a high sense of responsibility and can respond quickly
Travel: Occasionally
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.