Project Manager - End to End Biomarker Biospecimen Support for Clinical Trials

Submission for the position: Project Manager - End to End Biomarker Biospecimen Support for Clinical Trials - (Job Number: 175144)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.

As a Project Manager, you are expected to execute on Biospecimen Operations (BSO) service deliverables during study start-up and study maintenance under minimal supervision in a fast-moving team-based environment. The incumbent will provide biomarker specimen and clinical trial support across multiple, often complex, studies in oncology and also be the point person for receiving, registering and managing clinical samples that are received in the San Francisco facility. The ideal candidate is a team-player who is detail-oriented; is able to successfully multi-task, supporting several projects simultaneously; understands the broader context of support that he/she provides; and knows how to identify/recognize and resolve issues with minimal supervision.

Responsibilities while working onsite at a major biopharmaceutical client site will include, but are not limited to, the following:

You will be expected to drive internal and external work group results to support the department’s mission. In doing so, you are expected to stay current on the broader context of support that you provide, assess quality support from the process improvement perspective, identify gaps and needs, propose and drive solutions, You will also be expected to escalate/resolve issues, lead/facilitate effective meetings and manage conflict with minimal guidance. The primary responsibilities of this position are to support TD and clinical teams in the implementation and maintenance of biospecimen management strategies for often complex, global clinical studies in each of the following areas under minimal supervision:

1.Biospecimen operations: Maintain knowledge/status of assigned clinical protocols and be able to follow good clinical practices (GCP), standard operating procedures (SOPs) and working procedures (WPs). Might be called upon to assist in the authorship of SOPs and WPs. Be able to handle, identify and resolve complex biospecimen-related/site issues and implement viable solutions in a timely manner. Play a key role in planning and designing clinical trial and biospecimen operations support internally and externally.

2.Biospecimen management: Utilize software tools to track biospecimens, identify discrepancies, verify and document consent, and ensure compliant utilization of biospecimens by following written procedures. Maintain regular metrics of biospecimen activities for studies that he/she supports. Follow up and resolve discrepancies through communication with study team, sites, or CROs/vendors within specified timeframes.

3.Clinical study teams: Plan/design biospecimen handling logistics and review biomarker-related clinical documents clinical protocols, ICFs, CRFs for successful study start-up. Create and maintain biospecimen laboratory manuals and provide hands-on biospecimen processing training at clinical sites. Support clinical and/or CRO to review supporting biospecimen documentation, labels, requisition forms and manifests to ensure documented sample chain-of-custody and the rapid reconciliation of biospecimens.

4.CROs and Vendors: Work with manager and clinical development teams to plan/design biospecimen handling logistics with preferred vendors on the manufacture of sample collection kits and execution of associated logistics; will be expected to take on a primary role in working with scientists and analytical laboratories on generating work order requests, work specifications and logistics..

PPDFSP

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.

As a Project Manager, you are expected to execute on Biospecimen Operations (BSO) service deliverables during study start-up and study maintenance under minimal supervision in a fast-moving team-based environment. The incumbent will provide biomarker specimen and clinical trial support across multiple, often complex, studies in oncology and also be the point person for receiving, registering and managing clinical samples that are received in the San Francisco facility. The ideal candidate is a team-player who is detail-oriented; is able to successfully multi-task, supporting several projects simultaneously; understands the broader context of support that he/she provides; and knows how to identify/recognize and resolve issues with minimal supervision.

Responsibilities while working onsite at a major biopharmaceutical client site will include, but are not limited to, the following:

You will be expected to drive internal and external work group results to support the department’s mission. In doing so, you are expected to stay current on the broader context of support that you provide, assess quality support from the process improvement perspective, identify gaps and needs, propose and drive solutions, You will also be expected to escalate/resolve issues, lead/facilitate effective meetings and manage conflict with minimal guidance. The primary responsibilities of this position are to support TD and clinical teams in the implementation and maintenance of biospecimen management strategies for often complex, global clinical studies in each of the following areas under minimal supervision:

1.Biospecimen operations: Maintain knowledge/status of assigned clinical protocols and be able to follow good clinical practices (GCP), standard operating procedures (SOPs) and working procedures (WPs). Might be called upon to assist in the authorship of SOPs and WPs. Be able to handle, identify and resolve complex biospecimen-related/site issues and implement viable solutions in a timely manner. Play a key role in planning and designing clinical trial and biospecimen operations support internally and externally.

2.Biospecimen management: Utilize software tools to track biospecimens, identify discrepancies, verify and document consent, and ensure compliant utilization of biospecimens by following written procedures. Maintain regular metrics of biospecimen activities for studies that he/she supports. Follow up and resolve discrepancies through communication with study team, sites, or CROs/vendors within specified timeframes.

3.Clinical study teams: Plan/design biospecimen handling logistics and review biomarker-related clinical documents clinical protocols, ICFs, CRFs for successful study start-up. Create and maintain biospecimen laboratory manuals and provide hands-on biospecimen processing training at clinical sites. Support clinical and/or CRO to review supporting biospecimen documentation, labels, requisition forms and manifests to ensure documented sample chain-of-custody and the rapid reconciliation of biospecimens.

4.CROs and Vendors: Work with manager and clinical development teams to plan/design biospecimen handling logistics with preferred vendors on the manufacture of sample collection kits and execution of associated logistics; will be expected to take on a primary role in working with scientists and analytical laboratories on generating work order requests, work specifications and logistics..

PPDFSP

Education and Experience:Bachelor's degree in Life Sciences, healthcare related field or equivalent and relevant formal academic / vocational qualificationPrevious 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.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.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. .Proficient computer skills in Microsoft Office.Experience with databases and intermediate-level Excel a plusUp to 20% travel to clinical sites to train sites on biospecimen procedures.Strong verbal, written and presentation skillsSuperior time management, planning, and organizational skillsCompetent with specific computers and enterprise applications, including office productivityProven analytical skillsDemonstrated compliance with procedures and policiesAbility to perform multiple tasks effectively in a stressful environmentStrong client relationship management skillsAbility to work effectively with multi-level teamsWorking 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 activitiesRegular 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 qualificationPrevious 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.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.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. .Proficient computer skills in Microsoft Office.Experience with databases and intermediate-level Excel a plusUp to 20% travel to clinical sites to train sites on biospecimen procedures.Strong verbal, written and presentation skillsSuperior time management, planning, and organizational skillsCompetent with specific computers and enterprise applications, including office productivityProven analytical skillsDemonstrated compliance with procedures and policiesAbility to perform multiple tasks effectively in a stressful environmentStrong client relationship management skillsAbility to work effectively with multi-level teamsWorking 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 activitiesRegular 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 - End to End Biomarker Biospecimen Support for Clinical Trials - (Job Number: 175144)