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.
1. Carefully manage biospecimen accountability, chain of custody and quality.
2. Utilize software tools such as Labmatrix or related biospecimen management system to track biospecimens, identify discrepancies, verify and document consent and ensure compliant utilization of biospecimens by following written
3. Follow up and resolve discrepancies through communication with study team, sites or CROs/vendors within specified timeframes.
4. Provide regular reports and summaries of biospecimen tracking activity.
Items to Note:Typical Daily Work schedule (start/end times) = Candidates must be flexible to work hours that will support EU, East &
West coast time zones, within 40 hrs/week. Weekend work not required. 100% onsite work.
directly to third party labs. The candidate should have experience in
cross‐checking and resolving biospecimen attributes between EDC/IVR and vendor databases, commonly referred to as header reconciliation.
Grow your career within the scientific ladder, pursue project management, or develop into a leader. These are just a few career pathways available once you chose to Be with PPD.
Join PPD in our relentless pursuit of excellence! If you feel your skills are a fit for this position - apply now!
Education and Experience:
Bachelor's degree in medical technology, pharmaceutical science,
biology, other health related field or equivalent and experience that provides the skills and knowledge required to perform the
- Minimum of 1 year experience in a clinical trials environment or similar field
- Minimum of 1 years experience in a project management capacity
- Or equivalent combination of education, training, and professional experience that provides the individual with the required knowledge, skills, and abilities
- -2‐4 years clinical trial biospecimen management experience in a clinical/diagnostic laboratory or pharmaceutical/biotechnology R&D environment.
- Ability to follow good clinical practices (GCP), standard operating procedures (SOPs) and working procedures (WPs).
- Demonstrated understanding of basic principles in clinical research and PK biospecimen processing procedures involving blood and tumor biopsies.
- Experience in working with clinical trial protocols and informed consent.
- Detailed knowledge and experience in case report forms, EDC listings, central laboratories databases and query resolution
- Awareness of global biobanking issues; basic experience in working in organizations adhering to quality standards.
- Experience with Labmatrix, GSS or related sample management system is a plus.
- Knowledge of at least one data management system experience with SAS data sets and conversion procedures is a plus.
- Knowledge of MS Office program suite required.
- Intermediate‐level Excel is a plus.
- Professional inter‐personal skills and excellent oral/written communication.
- Leadership skills in conflict management, facilitation and negotiation a plus.
- Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
- Good computer skills
- General knowledge of clinical trial processes and programs
- Strong attention to detail and problem solving skills
- Effectively conduct oral presentations
- Demonstrated experience in identification and resolution of technical problems in a professional environment
- Ability to maintain a high degree of confidentiality with clinical teams
- Ability to attain, maintain and apply a working knowledge of applicable Procedural Documents
- Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
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 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
- Regular and Consistent Attendance