Clinical Site Lead (Medical Devices) at Abbott

Prague, Prague, Czechia

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Background in engineering, science, health science, nursing OR equivalent or related experience in cardiology (job description cuts off here)

Responsibilities

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

Skills

Clinical Study Management

Site Management

Study Execution

Regulatory Compliance

Data Quality

Monitoring

Clinical Investigation Plans

Medical Devices

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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