Project Manager - Biospecimen / Biomarker Operational Lead

Submission for the position: Project Manager - Biospecimen / Biomarker Operational Lead - (Job Number: 178784)

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.

Translates protocol-level sample needs into clearly defined deliverables in support of study start up with clinical sites and laboratory vendors. Understands team needs, communicates alignment with program testing strategy and escalates to Biospecimen Planning Mgmt for the TA where there are areas of departure from established standards or recommended guidelines. Leads his/her functional area in a matrixed environment, to ensure the biospecimen needs for study/asset are met per Planning specifications.

Job Duties:

• Support Biospecimen Planning in the development of Biospecimen Management and Lifecycle Plan: protocol, site feasibility, risk matrix, utilization plan.

• Supports Biospecimen Planning in the creation of documentation related to sampling strategies and updates, at each Go-To (GT) (or ad hoc as needed by scope/nature of changes to previously established standards) by providing valuable participation for critical biospecimen strategy meetings including internal and external engagement meetings.

• Supports multiple protocols under his/her accountability in close collaboration with vendors, scientists and planning management; with core expertise in Good Clinical Practice (GCP), clinical trial operations, risk management and project management.

• Able to operationalize a BOW across multiple vendors and assets.

• Drive vendor engagement, seeking opportunities to enhance value of external vendor relationships through early strategic engagement and ongoing partnership.

• Manages and owns study start up process with laboratory vendors, including performance monitoring and issue escalation. Align with Biospecimen Logistics and act as escalation POC to implement best practices and cost-effective sample routing at protocol-level.

• Ensure timely and efficient delivery of all biospecimen operational aspects of dynamic clinical studies, across all stages (start-up, execution/maintenance and close-out), with appropriate quality oversight and standards.

• Supports escalation of biospecimen operational concerns during the execution of a protocol.

• Supports Vendor Inspection/Audit to coordinate Vendor responses. Follows up on corrective and preventative actions to completion and implementation.

• Enforce and maintain Therapeutic Area vendor standards.

• Understands clinical site and vendor needs, communicating alignment with program testing strategy; escalates to protocol Biospecimen Planning specialist functions where there are areas of departure from established standards or recommended guidelines.

• Maintain monthly time metrics in support of protocol startup and execution in order to aid senior management review of overall drug development costs and team resource utilization as well as forecasting.

• Comprehensive operational review of vendor contracts.

• Support the implementation of IT capabilities to enhance operational effectiveness, biospecimen tracking, and operational data tracking/mining. Ensures all tasks are documented in alignment with the protocol.

• Demonstrates good communication, interpersonal and negotiating skills and leverages those competencies to ensure continuous progress within both internal and external teams thus moving issues to resolution

• Travel expectations are minimal, perhaps 5-10% domestic

PPDFSP *LI-SW1

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.

Translates protocol-level sample needs into clearly defined deliverables in support of study start up with clinical sites and laboratory vendors. Understands team needs, communicates alignment with program testing strategy and escalates to Biospecimen Planning Mgmt for the TA where there are areas of departure from established standards or recommended guidelines. Leads his/her functional area in a matrixed environment, to ensure the biospecimen needs for study/asset are met per Planning specifications.

Job Duties:

• Support Biospecimen Planning in the development of Biospecimen Management and Lifecycle Plan: protocol, site feasibility, risk matrix, utilization plan.

• Supports Biospecimen Planning in the creation of documentation related to sampling strategies and updates, at each Go-To (GT) (or ad hoc as needed by scope/nature of changes to previously established standards) by providing valuable participation for critical biospecimen strategy meetings including internal and external engagement meetings.

• Supports multiple protocols under his/her accountability in close collaboration with vendors, scientists and planning management; with core expertise in Good Clinical Practice (GCP), clinical trial operations, risk management and project management.

• Able to operationalize a BOW across multiple vendors and assets.

• Drive vendor engagement, seeking opportunities to enhance value of external vendor relationships through early strategic engagement and ongoing partnership.

• Manages and owns study start up process with laboratory vendors, including performance monitoring and issue escalation. Align with Biospecimen Logistics and act as escalation POC to implement best practices and cost-effective sample routing at protocol-level.

• Ensure timely and efficient delivery of all biospecimen operational aspects of dynamic clinical studies, across all stages (start-up, execution/maintenance and close-out), with appropriate quality oversight and standards.

• Supports escalation of biospecimen operational concerns during the execution of a protocol.

• Supports Vendor Inspection/Audit to coordinate Vendor responses. Follows up on corrective and preventative actions to completion and implementation.

• Enforce and maintain Therapeutic Area vendor standards.

• Understands clinical site and vendor needs, communicating alignment with program testing strategy; escalates to protocol Biospecimen Planning specialist functions where there are areas of departure from established standards or recommended guidelines.

• Maintain monthly time metrics in support of protocol startup and execution in order to aid senior management review of overall drug development costs and team resource utilization as well as forecasting.

• Comprehensive operational review of vendor contracts.

• Support the implementation of IT capabilities to enhance operational effectiveness, biospecimen tracking, and operational data tracking/mining. Ensures all tasks are documented in alignment with the protocol.

• Demonstrates good communication, interpersonal and negotiating skills and leverages those competencies to ensure continuous progress within both internal and external teams thus moving issues to resolution

• Travel expectations are minimal, perhaps 5-10% domestic

PPDFSP *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 5 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: Clinical Trials: Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials. Minimum of 5 years of experience in clinical drug development/clinical trial execution Basic understanding of clinical research/drug development, GCP, GLP, CLIA, data management, and regulatory and legal issues Basic understanding of Vendor, Clinical Site, stakeholder management Experience and fluency with MS Office tools (esp. MS Excel and Teams). SharePoint Effective organizational and time management skills on virtual and in-person settings Scientific/Laboratory Skills: Proficient knowledge of relevant therapeutic and technical areas; demonstrated understanding of laboratory techniques in the life sciences; demonstrated understanding of principles in clinical research and clinical procedures involving blood/biopsy collection, handling and processing. Demonstrated ability to analyze and interpret problems/data from a variety of sources, and through effective collaborating and utilization of resources, deliver strong business results. Basic knowledge of Risk Mgmt Proficient at operational data mining, biospecimen tracking processes and tools Biobanking: Understanding of global biobanking issues; proficient experience working in organizations adhering to quality standards and working with regulations pertaining to general biospecimen transportation requirements. Drug Development: Proficient understanding of the drug development process. Professional inter-personal skills and excellent oral/written communication. Experienced in presenting logistics and processing instructions, including basic scientific and clinical content, to internal and external audiences. Basic leadership skills in conflict management, facilitation and negotiation. Experience with databases and intermediate-level Excel a plus Up to 10% travel to clinical sites to train sites on biospecimen procedures. Strong verbal, written and presentation skills Superior time management, planning, and organizational skills Competent with specific computers and enterprise applications, including office productivity Proven analytical skills Demonstrated compliance with procedures and policies Ability to perform multiple tasks effectively in a stressful environment Strong client relationship management skills Ability to work effectively with multi-level teams 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 "Clinical site coordinator" , "study start-up", "end to end" , "project management" , "biospecimen management" , ICF, CFR, "vendor management" , "clinical trial"

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 5 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: Clinical Trials: Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials. Minimum of 5 years of experience in clinical drug development/clinical trial execution Basic understanding of clinical research/drug development, GCP, GLP, CLIA, data management, and regulatory and legal issues Basic understanding of Vendor, Clinical Site, stakeholder management Experience and fluency with MS Office tools (esp. MS Excel and Teams). SharePoint Effective organizational and time management skills on virtual and in-person settings Scientific/Laboratory Skills: Proficient knowledge of relevant therapeutic and technical areas; demonstrated understanding of laboratory techniques in the life sciences; demonstrated understanding of principles in clinical research and clinical procedures involving blood/biopsy collection, handling and processing. Demonstrated ability to analyze and interpret problems/data from a variety of sources, and through effective collaborating and utilization of resources, deliver strong business results. Basic knowledge of Risk Mgmt Proficient at operational data mining, biospecimen tracking processes and tools Biobanking: Understanding of global biobanking issues; proficient experience working in organizations adhering to quality standards and working with regulations pertaining to general biospecimen transportation requirements. Drug Development: Proficient understanding of the drug development process. Professional inter-personal skills and excellent oral/written communication. Experienced in presenting logistics and processing instructions, including basic scientific and clinical content, to internal and external audiences. Basic leadership skills in conflict management, facilitation and negotiation. Experience with databases and intermediate-level Excel a plus Up to 10% travel to clinical sites to train sites on biospecimen procedures. Strong verbal, written and presentation skills Superior time management, planning, and organizational skills Competent with specific computers and enterprise applications, including office productivity Proven analytical skills Demonstrated compliance with procedures and policies Ability to perform multiple tasks effectively in a stressful environment Strong client relationship management skills Ability to work effectively with multi-level teams 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 "Clinical site coordinator" , "study start-up", "end to end" , "project management" , "biospecimen management" , ICF, CFR, "vendor management" , "clinical trial"

Submission for the position: Project Manager - Biospecimen / Biomarker Operational Lead - (Job Number: 178784)