JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott  

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:  

• Career development with an international company where you can grow the career you dream of. 
• Competitive remuneration package including company car, private Medical & Life plan, and continuous learning opportunities within an excellent multinational working environment.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.  
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity 

For our Abbott Medical Devices business in Czechia we are looking for an experienced professional to join our international clinical team as a Clinical Site Lead. This is a field-based position that requires frequent travelling across assigned territory - mainly Prague and Czechia, plus occasionally other EU locations.

The Clinical Site Lead (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. The CSL is the subject matter expert in Clinical Investigation Plans and product/disease state throughout the lifecycle of the study: startup, enrollment, compliance and follow up, data quality, monitoring and study/site closeout.

What You'll do:

• Act as the main point of contact internally and externally for study sites.
• Coordinate, implement, execute and support clinical studies within assigned country/region.
• 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.
• 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.
• 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.
• Promptly reports 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.
• Train and retrain site personnel to ensure compliance with the study protocol and local regulations, as required or needed.
• Communicate internally on project progress to stakeholders.
• Provide continuous updates and follow up on studies and sites to Clinical Operations and Study Management.
• Be the point of contact for discussions, collaboration and updates with local/regional commercial teams.

Required qualifications and background:

• Background in engineering, science, health science, nursing OR equivalent or related experience in cardiology or clinical research.
• Fluency in English (both written and verbal) and Czech.
• At least 2 years of relevant experience in clinical research and/or clinical site management.
• 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.
• Experience working in a broader cross-division business.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to travel at least 70%, including internationally.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. 

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. 

     

The base pay for this position is

N/A

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

     

JOB FAMILY:

Clinical Affairs / Statistics

     

DIVISION:

MD Medical Devices

        

LOCATION:

Czech Republic > Prague : Evropska 2590

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 75 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable