PPD Project Manager - Biosample collection/processing compliance in Pennington, New Jersey
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.
In this position you will work with the Client study teams and vendors to ensure correct translation of protocol/asset sampling requirements into site deliverables (kits, vendor DB, lab manual, training, etc.) producing high quality research biosamples leading to the valid data. This team collaborates closely with Translation Medicine, Global Clinical Operations and Global Medical functions to ensure biosample collection/processing compliance from sites and optimal vendor performance in the area of biosample management.
The Project Manager is the process gatekeeper and expert related to clinical sample management processes. In this position you will be asked to efficiently and independently perform the functional duties and responsibilities leading to biosample collection/processing compliance from sites and optimal vendor performance in the area of biosample management. As well as develop and/or lead on functional improvement projects.
• Partners across the protocol team to ensure sample management needs are clearly understood and able to be contracted in accordance with Client policy.
• Translates protocol-level sample needs into clearly defined deliverables in support of study start up with clinical sites and laboratory vendors. Required reviewer during protocol development process as applicable
• Supports escalation of sample management concerns during the execution of a protocol. Ensures all issues are documented, advises on mitigation and remediation of issues, escalates issues and drives to closure in support of team goals and timelines.
• Identifies and monitors program-level and therapeutic area-level clinical sampling standards. Understands clinical team needs and communicates alignment with program testing strategy, escalates and partners with Translational Medicine functions where there are areas of departure from established standards or recommended guidelines as needed.
• Develops sample collection instructions for sites as needed to ensure clarity, quality and promote compliance. Supports the site/investigator training for proper collection techniques, time point requirements, and sample handling to ensure viability, integrity and data reliability.
• Supports biomarker and pharmacokinetic/immunogenicity sample and shipment tracking; assessing requirements, collaborating with internal and external partners for clarification and escalating issues to the clinical team as needed.
• Partners with site-facing roles to ensure compliance on sample management as applicable
• Supports the creation of documentation related to sampling strategies and updates at each DP (or ad hoc as necessitated by scope/nature of changes to previously established standards) by providing valuable participation for critical sample strategy meetings including internal and external engagement meetings.
• Participate as internal SME in Due Diligence efforts for third party Specialty Labs to ensure that specialty lab operations are functioning with an appropriate internal control environment, and meeting expectations of relevant regulatory requirements as dictated by the nature of the work entrusted to their execution as applicable.
• Actively serves as a liaison to other strategic and process improvement initiatives affecting assigned therapeutic areas as required.
• Encourages teams, both internal and external; to share knowledge, experiences, best practices, and information on an ongoing basis.
• Demonstrates good communication and interpersonal skills; leverages those competencies to ensure continuous progress of internal and external teams thus moving issues to resolution.
• Actively maintains a SOL Book of Work for his/her respective therapeutic area(s); ensuring protocol status and resource demand are updated for management assessment on a monthly basis.
• Maintain personal monthly time metrics in support of protocol startup and execution in order to aid senior management review of overall drug development costs.
• Displays strong written and oral communication skills. Works with all levels of staff and management to resolve issues and update on progress. Able to work with large and small teams to achieve business goals with professionalism and poise.
At PPD, we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.
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_What To Expect Next_
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.
Education and Experience:
Bachelor's degree 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, and experience
Knowledge, Skills and Abilities:
Knowledge of clinical biospecimen procedures including: collection and processing procedures, logistics considerations, chain of custody, issue escalation/resolution and data management highly desired.
Basic understanding of laboratory science (biospecimen collection/processing) required
5 years of experience in clinical drug development/clinical trial execution strongly preferred
Basic understanding of data management desired
Demonstrated ability to analyze and interpret problems/data from a variety of sources, and through effective partnering and utilization of resources, deliver strong business results.
Strong verbal, written and presentation skills
Superior time management, planning, and organizational skills
Competent with specific computers and enterprise applications, including office productivity
Ability to program the IT system according to protocol requirements
Proven analytical skills
Demonstrated compliance with procedures and policies
Ability to perform multiple tasks effectively in a stressful environment
Extensive knowledge and experience in Project Management in Global Central Lab environment
Strong client relationship management skills
Ability to work effectively with multi-level teams
/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 work upright and stationary and/or standing for typical working hours
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments
Able to use and learn standard office equipment and technology with proficiency
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
Job: *Project Management
Title: Project Manager - Biosample collection/processing compliance
Location: NJ-Pennington-FSP Hopewell NJ
Requisition ID: 168674
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group