Discover new opportunities to grow your career as a Covance by Labcorp FSP Start Up Project Manager.
Covance by Labcorp FSP are looking to hire a Start Up Project Manager in Hungary, Budapest. In this position you will be fully dedicated to our sponsor.
At Covance by Labcorp, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).
As a Covance by Labcorp employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance by Labcorp has an FSP opportunity to match your area of expertise.
Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance by Labcorp studies.
With the support of exceptional people and an energized purpose, you'll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.
- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
- Development of local language materials including local language Informed Consents and translations.
- Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
- Deliver the expertise in country based regulations, laws and procedures
- Provide an oversight and tracking of clinical research-related payments
- Overlook payment reconciliation at study close-out
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
- Previous significant experience in submission process on a country level
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
- Thorough understanding of the drug development process
- Fluent in local office language and in English, both written and verbal
- Good organizational and time management skills
- Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred
- Excellent communication skills, oral and written
- Self-motivation with the ability to work under pressure to meet deadlines
- Works well independently as well as in team environment
- Detail and process oriented
- Positive attitude and approach
- Interact with internal and external customers with high degree of professionalism and discretion
- Multi-tasking capability
- Good computer skills with good working knowledge of a range of computer packages
- Ability to lead and develop junior staff
- Flexible and adaptable to a developing work environment
- Proven clinical research experience
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