Covance Start-up Specialist I in Munich, Delaware

Job Overview

Covance is searching for a Study Start Up Specialist I to be office based in Munich. Candidates from other European countries with fluent or good German language skills are also very welcome.

Essential Job Duties:

  • Provide local support for clinical trial supply coordination, if applicable.

  • Ensure documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.

  • Collect, review, process, and track regulatory & investigator documents required for effective and compliant study site activation.

  • Ensure that all assigned start up activities are on track and support study deliverables.

  • Proactively manage sites to ensure timely site activation. Participate in team meetings to progress trials and identify site issues that might impact the timelines.

  • Escalate study issues appropriately and in a timely fashion. When needed, assist in preparation of Site Activation project specific plans.

  • Provide accurate projections and timelines to study teams agreed with Sponsor.

  • Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol. Review and update study documents when there are changes in study personnel/study amendments.

  • Liaise with Covance Regulatory department regarding document submission requirements, if applicable.

  • Proactively resolve informed consent issues and other potential difficulties with study sites.

  • Prepare submissions to IRB/IEC, and regulatory authorities if GRS requires input.

  • Liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/approval issues. Ensure high quality site documents are filed in the (e)TMF in a timely manner according to study plans.

  • Negotiate site contracts and budgets with sites, if applicable. Proactively track progress of contract and budget milestones/developments, intervening and escalating as appropriate. Undertake tasks delegated by senior team members, depending upon country and situational requirements.

  • Perform other duties as assigned by management.

Education / Qualifications

  • University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (eg. nursing certification, medical or laboratory technology).

Mandatory:

  • High proficiency with German language and English. Any other language is a plus.

Experience

  • Minimum of 2 years of experience in clinical development or regulatory process

  • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines

  • Familiarity with investigator start-up documents and contract/budgets negotiation process

  • Previous interaction with operational project teams and investigative sites Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them

Job Number 2018-25875

Job Category Clinical Study Start Up

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.