PROJECT MANAGER - BIOSPECIMEN / BIOMARKER OPERATIONAL LEAD
Posted on: January 16, 2022
JOB DESCRIPTIONPPD 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
- Able to operationalize a BOW across multiple vendors and
- 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
- 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
- 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
- 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
- Travel expectations are minimal, perhaps 5-10% domestic
- LI-SW1Job QualificationEducation and Experience:
- Bachelor's degree in Life Sciences, healthcare related field or
equivalent and relevant formal academic / vocational
- 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 environmentKnowledge, 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
- Experience and fluency with MS Office tools (esp. MS Excel and
- 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
- 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
- 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
- Experience with databases and intermediate-level Excel a
- Up to 10% travel to clinical sites to train sites on
- Strong verbal, written and presentation skills
- Superior time management, planning, and organizational
- 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
- Strong client relationship management skills
- Ability to work effectively with multi-level teamsWorking
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
- Able to use and learn standard office equipment and technology
- 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"
Diversity StatementPPD is proud to be an affirmative action
employer that values diversity as a strength and fosters an
environment of mutual respect. PPD is committed to providing equal
employment opportunities without regard to age, race, color,
pregnancy, national origin, religion, sex, gender identity, sexual
orientation, disability, veteran status or status within any other
Keywords: PPD, Trenton , PROJECT MANAGER - BIOSPECIMEN / BIOMARKER OPERATIONAL LEAD, Executive , Princeton, New Jersey
Didn't find what you're looking for? Search again!