Covance Start-up Project Manager in Budapest, Hungary

Job Overview

Are you someone with previous regulatory submissions experience looking for developing your career within this area?

At Covance we are recruiting for a SSU Associate Project Manager to work sponsor dedicated into a top 5 pharmaceutical company.

Responsibilities:

  • Assignment of site numbers

  • Identification of patients documents required for translation

  • Assessment of local sourcing availability of drug

  • Start-up timelines estimation

  • Oversight and coordination of CTC tasks during validation (support)

  • Coordination of collection of site documents required for EC/HA submission

  • Local ICF adaptation

  • Review and adaptation of patient recruitment and retention materials

  • Recruitment materials –

  • Cooperation and support of contract/financial team during contracting process

  • Providing update to study team members, i.e. CRM, CRAs, RCPM, CTC regarding current start-up status

  • Local IMP, drug and non-clinical supplies management

  • Coordination of preparation of ITFB

Get to know Covance

Here, you'll own your career, make an impact and be a part of a leading company that has supported development of 50 out of the top 50 prescription drugs in the market. Empowered by our LabCorp partnership and data for more than 70 million patients, we can offer clients a complete set of end-to-end clinical trial solutions aligned to global therapeutic needs. In return, you’ll be empowered in a flexible team environment with mentoring and training to get the most out of your career.

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.

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

  • In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered

  • 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

Experience

  • 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

Job Number 2018-24051

Job Category Hidden (23502)

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.