Project Manager - Biospecimen Planning Lead - 50% ...

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health. PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD. Position Summary This position will work closely with our Clinical Teams to develop and implement biospecimen management plan for Client-sponsored clinical trials and externally acquired biospecimens. Members of this team will develop and execute asset and protocol-level biospecimen strategies initially under the guidance of senior colleagues and work across the organization and with the Client''s partners to implement and project manage efforts to execute these strategies. Critical to this role is the ability to provide innovative solutions to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring Client''s continuous competitive advantage. The individual will be responsible for supporting biospecimen management for the Early or Late Development assets with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens. Responsibilities 1. Oversee and manage the complete lifecycle of biospecimens collected for Early or Late phase clinical studies with minimal supervision. 2. Core Clinical Team member responsible for providing Shipping/sample movement and management including requests, query and inventory reports, follow up active issues with vendors, prepare sample management related reports, review/prepare tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non viable samples, loading documents to Shared Drive folders, etc.). 3. Independently reviews clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and feedback with support as needed. 4. Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking. 5. Able, under direction, to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or Polaris (if applicable)) with support. 6. Able to identify biospecimen related risks with support from risk library. May require support for de novo risks and mitigation strategy proposals. Support Critical to Quality (C2Q) process with guidance, if needed. 7. Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance. May need assistance to help prioritize BOW activities during critical deadlines. 8. Maintain intermediate working knowledge of compound and study related biospecimen requirements. 9. Ensure completion of individual Study Transition Forms *LI-SW1 Education and Experience: Bachelor''s degree in Life Sciences, healthcare related field or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years'') or equivalent combination of education, training, & experience. Experience is to be in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment Knowledge, Skills and Abilities: Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data and risk management. Minimum of 2 years academic, biotech, healthcare or pharmaceutical industry experience or equivalent.Minimum of 2 years academic, biotech, healthcare or pharmaceutical industry experience or equivalent. Experience desired but not limited to: biospecimen life-cycle/operations, compliance, management and vendor management. Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent. Vendor experience preferred (e.g. Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc.). Ability to develop skills with training for stakeholder management including conflict and change management. Biospecimen Operations Experience preferred but not mandatory. Developing knowledge of the drug discovery or developmental process. Applies Scientific and/or functional knowledge to conduct studies in assigned area. Ability to effectively communicate, create and deliver presentation/information/data to knowledgeable audiences, with limited supervision. Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with a sense of urgency, accountability and integrity, and to have fun along the way."‹"‹"‹"‹"‹"‹"‹ Working Conditions: PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities Regular and consistent attendance As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment. ''Clinical site coordinator'' , ''study start-up'', ''end to end'' , ''project management'' , ''biospecimen management'' , ICF, CFR, ''vendor management'' , ''clinical trial'' This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.

Created: 2026-04-04