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JOB DESCRIPTION:

Abbott is recruiting a Senior Clinical Site Lead to be based in Zaventem, Belgium.

The Senior Clinical Site Lead (Sr CSL) drives study execution, operational excellence and site management across Abbott therapies and Business Units as per local and international regulations and abiding by Abbott’s procedures.

Role and Responsibilities

  • Act as the main point of contact internally and externally for study sites
  • Coordinate, implement, execute and support clinical studies
  • Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels and required data quality.
  • Identify appropriate investigators as defined by study-specific requirements
  • Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution as per working instructions
  • Facilitate all aspects of the start-up process in coordination with Site Operations team and lead activities to ensure site activation and project enrollments within timelines and defined forecasts
  • Develop site-specific strategies to promote appropriate patient enrollment.
  • Identify site successes and challenges and assist in implementing techniques that promote study goal achievement.
  • Attend study procedures and follow-ups when indicated per study specific requirements
  • Monitor clinical studies at sites to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.
  • Continuously evaluate site study performance and provide timely feedback to site.
  • Lead, initiate, coordinate and/or perform activities to ensure clinical study and regulatory compliance on site and as indicated, per Key Compliance Indicator and supports audits as applicable.
  • Ensure adverse events, device complaints and protocol deviations are reported in an efficient and timely manner per regulations and Abbott procedures
  • Resolve and/or facilitate resolution of identified issues including identification of cause and actions to prevent reoccurrence (drive development of CAPAs as needed and identified).
  • Promptly report the findings of monitoring visits as per timelines and standards identified in working instructions
  • Collaborate with Site Operations teams to ensure complete submission of study and filing of site and study documents
  • Contribute to site budget discussions and provide field perspective. Coordination with contracts associates on contract execution. 
  • Proactively, and with minimal guidance, look for ways to facilitate strong performance and capabilities of study sites within their region.
  • Work with sites to further develop their capabilities for clinical studies execution and protocol compliance
  • Communicate to leadership and study teams proactively and in a timely manner, all study and site updates critical to clinical priorities.

Your Profile:

  • Degree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology or clinical research.
  • At least 5 years of relevant experience in clinical research and/or clinical site management
  • Fluency in English (both written and verbal) and local/country. Any other European language is an asset
  • Knowledge in the use of MS Office, Clinical Database (preferably Oracle)
  • Communication, prioritization, organizational and time management skills
  • Team player with positive constructive attitude
  • Strong self-development abilities and able to work independently
  • Proficient knowledge of medical terminology.
  • Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA).
  • Expertise in study conduct, follow up and monitoring
  • Advanced knowledge of clinical and outcomes research study design.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ability to work in a highly matrixed and diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Ability to travel at least 70%, including internationally.

Abbott offers an attractive salary combined with good opportunities to grow and develop. If you recognize yourself in this profile and you would like to know more, please apply online.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Research and Discovery

DIVISION:

MD Medical Devices

LOCATION:

Belgium : Building Figueras Da Vinci Laan, 11 Box F1

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 75 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

Read Full Description
Confirmed 11 hours ago. Posted 6 days ago.

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