Abbott Medical is looking for an
**Field Clinical Operations Specialist**
As a Field Clinical Operations Specialist you ensure that assigned clinical projects are planned, conducted and progress/results communicated in compliance with relevant local, national and international clinical trial regulations/guidelines and with the highest standard of quality defined by Company Standard Operating Procedures (SOPs) and by Good Clinical Practice. You participate to the promotion of Abbott professional image as a clinical and scientific company.
**Roles & Responsibilities**
+ Coordinate, implement, execute and support all the assigned Clinical Projects
+ Facilitate/support adequate site activation times, enrollment rate and data quality with regular and frequent visits to the assigned centers
+ Take proactive measures to ensure site activation and project enrollments within timelines and defined forecasts
+ 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 (if applicable) and be responsible of the correct study documents archiving
+ Communicate internally on project progress to stakeholders (internal and external)
+ Develop/coordinate/execute action Plans and collect all projects associated documents
+ Identify and qualify appropriate study sites, physicians and staff in accordance with all internal stakeholders and SOPs.
+ 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
+ Coordinate and communicate regularly with Investigators and Steering Committee / Adjudication committee / DSMB members
+ Ensure regular payments of project fees as per agreements and proper communication between the 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
+ Coordinate data analysis for local projects (when applicable)
+ 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
**Education & Background:**
+ Medical/biomedical/bioengineer/bioscience/scientific background (MS/BS/Engineer/PhD/MD, etc) or relevant previous experience
+ Fluency in English (both written and verbal), any other European/local language is an asset
+ Proficiency in MS Office, Clinical Database (preferably Oracle),
+ 5-10 years of experience in clinical projects, as project leader or CRA, in medical device, biotech or pharmaceuticals industry/CRO
+ Excellent communication, prioritization, organizational and time management skills
+ Team player with positive constructive attitude to solve problems. Eager to learn, stress resistant
+ Strong self-development abilities and able to work independently
+ Organized, on-time, and detailed project management skills.
+ Energized attitude.
+ Proficient knowledge of medical terminology.
+ Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA).
+ 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 leverage and/or engage others to accomplish projects.
+ Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
+ Ability to travel at least 70%, including internationally.
+ Ability to maintain regular and predictable attendance.
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