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Investigational Product Specialist
Het bedrijf / The company
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.
A career with Syneos Health means your everyday work improves patients" lives around the world.
De functie / The role
Here at Syneos Health we are currently we are recruiting for an Investigational Product Specialist (IPS) to work in our FSP 360 department. This means you are fully employed by Syneos Health, while solely working for one single sponsor. The pharmaceutical company you will be outsourced to is located in Amsterdam.
As Investigational product specialist you are responsible and accountable for the local management of Investigational Medicinal Product (IMP); to ensure that shipment, handling and storage of the IMP, NIMP and other study material is done and documented according to the SOPs and local law and regulation. The IMP shipped is for the use in all clinical trials organised by the Clinical Studies Unit (CSU) in The Netherlands, Phase I to Phase IV.
This responsibility and accountability extends to managing the IMP either through an in-house distribution centre or through a local sub-contractor. The IPS will provide appropriate input and support for the IMP and material handling to all monitoring teams and is the main contact person for the corporate team and external providers if needed and is responsible to implement efficient processes and to identify issues and solutions thereof. Further he/she supports the Cluster IP Manager on improvement of processes/tools linked with IP Management and actively collaborates and interacts with the local management team. The IPS participates in team meetings as deemed necessary and exchanges experiences and solutions with the Cluster IP Manager and colleagues within the Cluster.
To achieve success, it is critical for the IP Specialist:
o To control IMP stock, dispatch and reconciliation for clinical trials conducted by Clinical Studies Unit.
o Assist the Cluster IP Manager in the management of the in-house distribution centre or local sub-contractor for IMP services
o To effectively track expenses accrued in IMP management to enable invoices to be validated before approval.
o To track supplies stored with sub-contractor (e.g. test strips, needles) and manage effectively for best business value.
o To ensure timely and effective communications are maintained at all times with CSU study team members about issues pertaining to the IMP for their study.
o To ensure all IMP is supplied, handled, and destroyed in complete compliance with EU and Dutch regulations, GCP guidelines and company Corporate and Local SOPs
o Act as the main local contact for all issues pertaining to IMP management for the CSU with both internal and external customers.
o To ensure complete traceability and accountability for all IMP used by CSU in the conduct of clinical trials.
o Ensure at all times that a full trail of IMP documentation is present in the Local Study File (LSF) for audit and regulatory inspections.
o Screen all IMP related documents, provided by the Monitoring Team (MT) or through other sources, applicable to the management of IMP for accuracy and completeness and file in the LSF for audit and regulatory inspections.
o Assist the Cluster IP Manager and the CSU Clinical Trial Regulatory Manager (CTA-RM) in the review and approval of the IMP labelling for any assigned clinical studies in accordance with the applicable regulations.
o Advise the Cluster IP Manager (in liaison with the Start-Up/Regulatory team) that appropriate essential documents are in place to allow submission of the IPSO1 to Corporate to request IMP is imported to the Netherlands.
o Manage the process of authorisation for the distribution of IMP supplies utilising the necessary documentation from SOPs, investigational centres and the local sub-contractor managing the supplies.
o Prepare and maintain a tracking tool to record the regulatory information required by the applicable laws for IMP: this will include essential information such as records of shipment, receipt, disposition, return and destruction including details of expiry dates, batch numbers and drug reconciliation.
o Assist the Cluster IP Manager in the effective management of sub-contractors contracted to manage IMP. Co-ordinate and be the main local contact for the process of IMP deviations (e.g. temperature excursions) until resolution
o Co-ordinate and be the main local contact for the process of IMP complaints until resolution.
o Upon the instructions of the Cluster IP Manager, co-ordinate and be the main local contact for any IMP re-labeling processes.
Het profiel / Your profile
o Educated to degree level
o Experience in IP distribution /clinical research
o Previous experience in clinical research or logistic Knowledge of the statutory requirements of IPM management in The Netherlands as defined by the EU Commission Directive 2030/94/EC, EU Commission, GMP, Annex 13, GDP, EU Clinical Trial Directive and ethical guidelines.
o Knowledge of and experience with GCP, GDP and other regulations in force; ability to learn and apply SOPs and quality control.
o Excellent interpersonal, communication and organisational skills.
o Fully competent in the use of word-processing and familiarity with other relevant IT packages (MS word, MS PowerPoint, MS Excel) required to fulfil the role.
Reactie / Reaction
If you are interested in this role and you believe you would be the right fit, we would be more than happy to hear from you. You can apply online or directly reach out to one of our Benelux recruiters, Eveline Wigtman or Irene Houtsma.