We are now looking for a professional with profound knowledge in GCP and GMP matters and excellent management skills to work in a challenging global role in a growing IxRS & Medication Management team in Finland in Espoo as
IxRS and Medication Manager
Your tasks and responsibilities
- Revise / develop the clinical study protocol regarding identity of study drugs including comparators, medical devices, randomization and blinding
- Ensure proper supply of study medication for all patients in a clinical trial by implementing optimal IxRS supply strategies whilst taking risks of partial unblinding into account
- For studies without an IxRS, you will monitor and assess clinical supply demands to ensure clinical and clinical supply requirements are met. You are also responsible for the supervision of the distribution of clinical supplies from central to local depots and from depots to sites.
- Responsible and accountable for the process of assessment of the usage of study medication that has been affected by a temperature excursion at site, in co-operation with the Quality-Function, to make certain that no drug whose pharmaceutical quality has been affected negatively can be taken by patients.
- Responsible for expiry date tracking of study medication on the study level and taking of appropriate action in case of study drug expiration to exclude any potential harm of patients caused by taking expired medication. If the shelf life of a batch of study medication can be extended you will initiate and supervise the process of labeling of medication packs with the new expiry date in accordance with the applicable GMP regulations and legal requirements.
- Support correct storage as well as drug accountability and support monitors in destruction of study medication at site.
- Lead the Interactive Voice/Web Recognition System (IxRS) cross-functional sub-team, who has the responsibility for the setup and maintenance of the IxRS System.
- You are accountable for the selection, setup and maintenance of the IxRS System with special attention to the proper and correct supply of study sites with study medication, including the correct drug dispensation according to the study protocol.
- Perform ongoing vendor management such as performance management and issue resolution at a study level
- Responsible for providing guidance and training to study teams, monitors and site personnel on the handling of study medication and the IXR System.
- Create and maintain drug handling instructions / Pharmacy manual if required
- Share knowledge and experiences within Clinical Development and other relevant stakeholders
- Ensure Compliance with all relevant SOP’s, GMP, GCP and ICH guidelines, as well as with legal and ethical standards
- You will contribute to Expert Working Groups as a team member.
Who you are
- Bachelor’s Degree or equivalent. Pharmacist degree preferred
- Profound knowledge in drug development
- Knowledge in setting up Interactive Voice/Web Recognition Systems (IxRS)
- Profound knowledge in GCP and GMP matters
- Excellent project management skills
- Excellent communication skills (including fluent English)
- Excellent Presentation Skills
We offer a competitive compensation, independent and challenging role in an international environment with a chance to develop your skills and experience further. To be considered for this exciting opportunity, please submit your application by Thursday March 10, 2021. Candidates will be reviewed on continuous basis.
If you feel this unique role is just what you are looking for, we are keen to hear from you! For further information, please contact Jutta Lindborg, Head of Women’s Health (Clinical Project Management). Wednesday March 3, 2021 at 12.00–13.00 (EET), phone +358 44 500 5272.
Functional area: Clinical Development & Operations
Seniority level: Professional