Who is PPD Clinical Research Services?
PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers. PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine
The PPD FSP Solution:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.
Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
PURPOSE OF THE FUNCTION
- Serves as a key reference contact for all clinical trial sample related questions.
- Helps to develop template documents to be used for tracking the clinical samples in the clinical trials, creates the trial specific templates and ensures timely completion and follow-up thereof, works together with the therapeutic indication/clinical trial team to agree and follow-up on what to do with the samples remaining after the trial specific analyses (left-overs and back-ups), where to store and what analyses to be performed/are allowed.
- Reviews the sample related paragraphs in the study documents and ensures consistency across the different studies, where needed.
ROLES AND RESPONSIBILITIES
- Key contact for all clinical trial sample related activities/questions towards the external labs, the internal team as well as during inspections and audits.
- Responsible to create template general and study-specific sample tracking documents.
- Use the template to create the trial specific files. Ensure that this file is kept up-to- date to reflect the status of the samples taken as well as their location.
- Check if all the required samples are taken according to the protocol, if not: follow- up on missing samples. Ensure that no samples are taken which are not per protocol.
- Coordinate the shipment of samples from the central lab to the satellite labs in line with reconciliation activities.
- Ensure that at the end of the trial a decision is taken with re. to storing or destroying the remaining samples. Ensure that the status is tracked in the sample tracking file. Ensure that what is to be done, is in line with what is in the Informed Consent of the respective individual subjects and regulations.
• Track, per subject, what they agreed upon in their Informed Consent with re. to (future) analysis of their samples. In case a subject withdraws his/her consent: make sure that the central and satellite lab(s) are informed about what is to be done with the samples of such a subject. Ensure that what is done, is tracked.
- Review the sample related paragraphs in the study documents and ensure, where needed, consistency across the different studies.
SKILLS AND COMPETENCIES
- Knowledge of ICH-GCP and other applicable legislation.
- Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, excel, eCRF databases, LIMS).
- Project Management and organizational skills.
EDUCATION, EXPERIENCE AND QUALIFICATIONS
- Expected educational qualifications: Bachelor’s degree or University degree – medical or paramedical (pharmacy, Biology, veterinary etc.) or equivalent by experience.
- Expected experience: Minimum 1 year experience in similar position or position within GCP clinical trial setting.
- Biotech experience is a plus.
Our 4i values:
- Integrity - Innovation - Intensity - Involvement -
If you resonate with our four principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you. Please note only short-listed candidates will be contacted.
Work Environment Requirements:
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.
PPD® FSP: People Who Deliver | PPD Careers - Read about PPD employee experiences!