Project Manager - Biospecimen - Planning Management

Submission for the position: Project Manager - Biospecimen - Planning Management - (Job Number: 182113)

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.

Our client is developing a world-class Global Biospecimen and Imaging Management (GBSIM) organization within Global Development Operations (GDO) to drive excellence and innovation in end-to-end biospecimen and imaging management to support the objectives of both Research and Development. Planning and operationalizing the clinical trial biospecimen plan is critical to support these objectives are key.

As such, we are recruiting a Project Manager for Biospecimen Planning who will work closely with our clients Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-4 clinical trials and externally acquired biospecimens. Members of this team will develop and execute asset and protocol-level biospecimen strategies and work across the organization and with 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 Late & Full Development assets with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens.

RESPONSIBILITIES

• Develop and document the Protocol Biospecimen Management Plan

• Ensure consistency and standardization of Biospecimen Management Plan at asset or indication level.

• Core Clinical Team member responsible for providing timely updates on sample collection, analysis, and data return.

• Work closely and provide guidance to Clinical Biospecimen Operations Team, Pharmacodiagnostic, Companion Diagnostics Team, and Clinical Operations, for sample and data updates, and coordinate sample movements needed for analysis or long-term storage

• Acts as escalation point for biospecimen assay results for Clinical Team.

• Work closely with the GBSIM Team and the clinical study teams to address informed consent and IRB/EC questions related to biospecimen

• Represent GBSIM team in protocol level meetings and teams on an ad hoc basis

• Able to proactively and independently investigate and develop process improvement for GBSIM

• Planning, coordinating and overseeing all planning activities required to manage the lifecycle of biospecimen samples (collection, processing, analysis, data delivery and cleaning process, and final sample disposition)

• Ensuring review of lab specifications and manuals as well as sample handling training and collection/processing materials for investigator sites/monitors together relevant internal and external stakeholders and the central lab.

• Directs/manage book of work with team members. Acts as mentor to new hires.

• Assist clinical protocol study team with study related documents, training of sites, queries, regulatory issues/concerns, and audits.

• Manages and owns study start up process with Clinical Team, including performance monitoring and issue escalation.

• 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.

Our client is developing a world-class Global Biospecimen and Imaging Management (GBSIM) organization within Global Development Operations (GDO) to drive excellence and innovation in end-to-end biospecimen and imaging management to support the objectives of both Research and Development. Planning and operationalizing the clinical trial biospecimen plan is critical to support these objectives are key.

As such, we are recruiting a Project Manager for Biospecimen Planning who will work closely with our clients Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-4 clinical trials and externally acquired biospecimens. Members of this team will develop and execute asset and protocol-level biospecimen strategies and work across the organization and with 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 Late & Full Development assets with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens.

RESPONSIBILITIES

• Develop and document the Protocol Biospecimen Management Plan

• Ensure consistency and standardization of Biospecimen Management Plan at asset or indication level.

• Core Clinical Team member responsible for providing timely updates on sample collection, analysis, and data return.

• Work closely and provide guidance to Clinical Biospecimen Operations Team, Pharmacodiagnostic, Companion Diagnostics Team, and Clinical Operations, for sample and data updates, and coordinate sample movements needed for analysis or long-term storage

• Acts as escalation point for biospecimen assay results for Clinical Team.

• Work closely with the GBSIM Team and the clinical study teams to address informed consent and IRB/EC questions related to biospecimen

• Represent GBSIM team in protocol level meetings and teams on an ad hoc basis

• Able to proactively and independently investigate and develop process improvement for GBSIM

• Planning, coordinating and overseeing all planning activities required to manage the lifecycle of biospecimen samples (collection, processing, analysis, data delivery and cleaning process, and final sample disposition)

• Ensuring review of lab specifications and manuals as well as sample handling training and collection/processing materials for investigator sites/monitors together relevant internal and external stakeholders and the central lab.

• Directs/manage book of work with team members. Acts as mentor to new hires.

• Assist clinical protocol study team with study related documents, training of sites, queries, regulatory issues/concerns, and audits.

• Manages and owns study start up process with Clinical Team, including performance monitoring and issue escalation.

• 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: Prior experience in biospecimen life-cycle/operations, compliance and management Basic understanding of Vendor, Clinical Site, stakeholder management Deep knowledge of clinical research, GCP, GLP, CLIA, data management, risk management, and regulatory and legal issues Expert in Excel functions; along with good time management, planning, record keeping and organizational skills. Deep knowledge of clinical biospecimen procedures and lifecycle including: collection and tracking procedures, logistics considerations, chain of custody, issue escalation/resolution and data management highly desired. Ability, willingness to learn; strong desire to grow and develop skills. Good written and oral communication skills; preferred basic experience in developing training and/or informational material and presenting to both internal and external stakeholders. Experience and fluency with MS Office tools (esp. MS Excel, MS PowerPoint) 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. 3-5 years biotech or pharma industry experience with scientific degree (BS, MS or higher). Basic understanding of Vendor, Clinical Site, stakeholder management 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 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: Prior experience in biospecimen life-cycle/operations, compliance and management Basic understanding of Vendor, Clinical Site, stakeholder management Deep knowledge of clinical research, GCP, GLP, CLIA, data management, risk management, and regulatory and legal issues Expert in Excel functions; along with good time management, planning, record keeping and organizational skills. Deep knowledge of clinical biospecimen procedures and lifecycle including: collection and tracking procedures, logistics considerations, chain of custody, issue escalation/resolution and data management highly desired. Ability, willingness to learn; strong desire to grow and develop skills. Good written and oral communication skills; preferred basic experience in developing training and/or informational material and presenting to both internal and external stakeholders. Experience and fluency with MS Office tools (esp. MS Excel, MS PowerPoint) 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. 3-5 years biotech or pharma industry experience with scientific degree (BS, MS or higher). Basic understanding of Vendor, Clinical Site, stakeholder management 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 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 - Planning Management - (Job Number: 182113)