Covance Associate Start-up Project Manager in Budapest, Hungary
Discover new opportunities to grow your career as a Covance FSP Associate Start-Up Project Manager.
Are you someone with previous regulatory submissions experience looking for developing your career within this area?
At Covance we are recruiting for a Start-Up Associate Project Manager to work sponsor dedicated into a top 5 pharmaceutical company to be based in Hungary, Budapest.
At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).
As a Covance 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 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 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.
FINANCIAL (as applicable):
Assistance with the ownership of country and site budgets.
Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Oversight and tracking of clinical research-related payments
Payment reconciliation at study close-out.
COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable):
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.
MANAGEMENT & QUALITY OVERSIGHT:
Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
Contributes to the development of local SOPs.
Education / Qualifications
- 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
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
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
Job Number 2019-28269
Job Category Clinical Operations Entry Level
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.