Field Clinical Operations Specialist
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**Ensure the execution of Clinical Projects through the UK. Although this is a field based we expect applicants to live within a commutable distance (within two hours) from a major airport and be based within an area which has** efficient **transport links (rail & road) throughout the UK.**
+ Implement and support all the assigned Clinical Projects particularly within Cardiac Rhythm Management and Electrophysiology.
+ Facilitate/support adequate enrollment rate and data quality with regular and frequent visits to the assigned centers
+ Take proactive measures to ensure project enrollments within timelines and defined forecasts
+ Coordinate timely and quality data collection
+ Arrange ad-hoc meetings or activities for data quality improvement
+ Guarantee data quality through periodic reporting on CRF status, site compliance and regular visits to the centers
+ Ensure compliance in safety reporting
+ Guarantee periodic communication to ECs and CA according to the applicable legislation and be responsible of the correct study documents archiving
+ Coordinate projects monitoring activities in cooperation with the Field CRA
+ Communicate internally on project progress to stakeholders
+ Develop/coordinate Clinical Project Plans and all projects associated documents
+ Identify and qualify of appropriate study centers, physicians and staff in accordance with all internal stakeholders and SOPs.
+ Train field people assigned to projects
+ Ensure project products availability and traceability (if applicable)
+ Ensure study/country/center specific essential documents are generated and filed in project administrative binders/OC database and project folders on internal network
+ Define requirements and coordinate service providers (if applicable)
+ Coordinate and communicate regularly with Investigators and Steering Committee / Adjudication committee / DSMB members
+ Ensure regular payments of project fees as per agreements
+ Ensure proper communication between the Italian Investigators and BCC/US for sub analysis, publications and data management for Global projects
+ Take active role in presenting clinical activities in local internal and external meetings
+ Ensure full compliance to all Abbott procedures and process such as all Clinical SOPs; HR procedures; Quality and Regulatory SOPs; 231 Law; Code of Business Conduct Coordinate data analysis for local projects
+ Be the clinical reference point for local clinical activities in the assigned area
+ Support statistical analysis for local projects
+ Plan and support physicians on scientific communication for local projects
**Education and experience** :
+ Candidates must hold at least a BSc degree in a relevant discipline and / or have experience in the medical devices industry.
+ Experience within clinical projects, as a project leader or CRA, in medical device, biotech or pharmaceuticals industry/CRO or clinical setting.
+ Must have strong communication and leadership skills, and good PC utilization skills.
+ Experience in cardiology medical devices is required, preferably within Electrophysiology and/or Cardiac Rhythm Management.
+ Must be willing to travel extensively both in and outside of the UK.
As you'd expect from a global healthcare company, we offer a fantastic range of benefits including competitive salaries, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org
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