CLINICAL & ANCILLARY SUPPLIES SPECIALIST, EMEA

Labcorp Drug Development

Kiev, Ukraine

4 днів тому

Job Overview :

IMPs don t fall from heaven IMP on site on time is the result of substantial coordination and planning.

This is what our Drug Supply & Ancillary Supplies Specialists live for : orchestrating the activities that will allow the entire clinical supplies lifecycle happen smoothly, no mistakes, no delays.

We have an opened a Global Drug Supply & Ancillary Supplies Specialist job in Europe :

During COVID pandemic, the role is 100 % remote. After this period passes, the job most likely will be a hybrid office and home-based a few days a week.

Labcorp has supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.

Frost & Sullivan has recognized us with the 2020 Global CRO Company of the Year Award. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.

We can offer you not only a job, but a stable, long-term international career.

THE JOB

You will be accountable for the set-up and maintenance of all logistical activities around IMP / NIMP and Ancillary Supplies (implementing and monitoring the whole supply strategy, ensure IMP are labelled, packaged, released and distributed in the best way to support the start and the quality of the whole Clinical Trial) from the issue of the protocol until the final reconciliation at study end for your assigned projects.

To thrive in this job you will :

translate study protocols into operational demand

have to take ownership and drive IMP label development. The design and customization of core and country labels (at a global level) will be essential for your success, and the bread and butter of a normal day for you here.

be engaged with primary and secondary packaging design and provide input to Drug & Ancillary Supply Forecasting projections, and IMP Distribution Plans, contracting and managing with Covance s drug distribution external partners to make them happen.

coordinate the regulatory and logistics aspects of importation

ensure connection and alignment of the various stakeholders to ensure the delivery of IMP / NIMP and ancillaries on time at the right quality and within budget

You will enjoy having a consultative role advising globally (EU, Americas, AsiaPac) on site storage, resupply, returns, drug inventory and expire date tracking processes.

EMEA AND THE SAME JOB REF

LI-NC1 EMEA Remote

Education / Qualifications :

Required :

University / College Degree (preferably postgraduate degree) AND 4 years relevant clinical research / GMP experience

Thorough understanding of global drug development and the clinical trial project management process, with a special emphasis on investigator sites, patient recruitment and retention

Thorough and practical working knowledge of ICH-GCP Guidelines, Clinical GMP, including relevant international requirements / guidelines for the conduct of global clinical development programs

In lieu of the above requirements, candidates with >

six (6) years clinical research experience including monitoring in the pharmaceutical or CRO industries will be considered

Preferred :

3 years Experience in Clinical Supply distribution / GMP environment

Experience : IS THIS YOU?

IS THIS YOU?

In this job, you will be doing much more than managing drug inventories from pre-study activities to Drug Ready, through maintenance until destruction;

providing global advice as internal expert, and working in collaboration with a wide range of teams needing your input for them to deliver (Clinical Trial Design & Strategy, Vendor Management, Quality Assurance, Business Development and Operations) that s you.

For that reason, we need you to be able to independently interpret complex clinical protocols and create your action plans out of that understanding, so you are familiar with :

The different study and protocol designs

Drug formulation

Stability

Packaging / Labeling design and operations

Drug Supply Logistics

GMP Annex 13

This is why we are particularly interested in candidates who have developed that clinical research knowledge working in an international CRO, ideally with end to end (full service) clinical and ancillary supplies management, directly liaising with third party clinical supplies packaging and labeling projects.

At least 3 years background in Clinical Supply distribution / GMP environment

Also important for this job is your experience in roles where you have had to inspire effective teamwork and motivate staff within a matrix system, so you excel at networking abilities.

You are an expert developing specifications for IxRS systems.

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