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.
Qualifications
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 company 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
