Clinical Bio-Sample Manager

Position Summary: The Clinical Bio-sample Manager (CBM) is a highly visible individual contributor role, a key position within the Clinical Operations Department. The CBM will be the primary liaison and subject matter expert (SME) for the operational activities involving the Clinical Operations Clinical Pharmacology, Research, CRO, sites and the multiple laboratories performing bio-sample logistics and analysis in support of clinical development trials and programs. For protocol specific Clinical Bio-sample Manager, in consultation with cross-functional stakeholders plans and co-ordinates operational activities supporting bio-sample integrity and data delivery timelines. Accountable and responsible to ensure bio-sample collection for multiple trials, timely delivery of bio-samples and associated data in support study analysis. The CBM will also be responsible for optimal quality and in compliance with SOPs, ICH/GxP/GLP/GDP and other relevant regulatory guidelines and ensure proper long-term sample storage and future sample management related to these stored samples.

Essential Duties and Responsibilities: Operates with an enterprise perspective and data-driven mindset, influencing stakeholders/others to achieve cross-functional alignment toward a shared purpose Ensures standardization and harmonization of bio-sample processing and throughput activities across clinical trials for optimal sample accrual and quality Sets clear strategies, robust implementation plans, streamlines and eliminates obstacles with agile decision making informed by relevant data In consultation with clinical outsourcing, clinical pharmacology, research teams, and other key stakeholders, provides input for lab vendor selection, lab vendor management and long-term sample storage planning Contributes to the budget development, review invoices against work completed, support financial accrual activities In consultation with Study Execution Team (SET) plans and co-ordinates delivery of bio-samples and associated data to align with trial objectives and critical trial operation milestones Participates in and may facilitate cross-functional study teams, liaise with other functional areas (Clinical Pharmacology, Clinical Sciences, Regulatory Affairs, Research), CROs and sites to accurately co-ordinate bio-sample activitieS Knowledgeable of sample import/export requirements by country Creates and/or implements a program/trial level Clinical Operations Bio-sample management plan that aligns with trial/program objectives, and compliant with SOPs, ICH/GxP/GLP/GDP Ensures development and availability of laboratories’ vendor management plans per SOPs. Provides input on relevant bio-sample information required for development of study Informed Consent templates Creates and/or leverages tracking systems to report progress, address issues and resolutions Oversees, facilitates, and tracks door-to-door sample disposition i.e. investigative sites, couriers, and laboratories for local/regional and global clinical trials of moderate to high complexity Anticipates, identifies, escalates and provides actionable recommendations for issues that may impact bio-sample quality, analysis/data integrity, custody of samples, timelines, cost, etc. Develops and/or leverages appropriate systems, standards, training modules, and processes to ensure quality and data integrity

Qualifications: Minimum of a bachelor’s degree or global equivalent; science degree preferred At least 3-5 years of direct experience managing multiple vendors (CROs, laboratory), or advanced degree (MS) with at least 4 years global clinical trial management experience, previous clinical bio-sample (PK/PD biomarker) management experience preferred Hematology experience, Project Management Professional (PMP) certification a plus Proficient knowledge and experience operating within ICH/GXP/GLP/GDP guidelines Experience working in a matrix environment, with competing priorities, managing stakeholder expectations and requirements Proficient knowledge of clinical drug development processes, clinical protocols and study design, study planning and management Proficient project and risk management skills Proficient interpersonal, written, and verbal communication, and technical skills Proficient computer skills i.e. MS Word, PowerPoint, Excel; MS Project/Smartsheet a plus Entrepreneurial spirit, comfortable working with minimal supervision in a fast-paced global Clinical Operations environment NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.