Abbott Supervisor Clinical Study Coordinator in Zaventem, Belgium
The Clinical division of Abbott Medical Devices in Belgium is looking for a SUPERVISOR for the CLINICAL STUDY COORDINATOR team .
Working under general supervision, the Supervisor provides direct supervision over the Clinical Study Coordinators (CSC) and provide administrative support to the clinical study teams.
ROLES & RESPONSIBILITIES
- Supervisor Responsibilities
Supervises the department’s CSCs. Ensures employee compliance with Abbott policies and procedures.
Develops and trains staff; critiques, mentors, evaluates, and coaches.
Provides back up support to study teams as needed.
Ensures that the Study needs are met in a timely and efficient manner.
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align with study goals.
Ensures that the CSC personnel are updated and advised on new or changed processes, procedures, and policies.
Oversees the workload of the CSC staff so that the work is balanced and the skills match the workload.
Identifies and promotes the process of continuous quality improvements.
- Provide support to Clinical Project Teams
Coordinates filing activities for the study teams while ensuring that the services provided are of high quality. Ensure maintenance of essential study records.
Collects/organizes investigator and site information and prepare/follow-up on site activation documents.
Track study related information (site/study status, enrolment, IRB/EC status, regulatory documents).
Create site regulatory/subject binder(s) as well as other study related documents and ship to sites.
Assist with creation and maintenance of consulting agreements for committee members or consultants.
Collect, file and de-identify adverse event source documents.
Assist team personnel with site activation and closure activities.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Provides input to the department’s standards, practices, and policies.
Performs other related duties and responsibilities, on occasion, as assigned.
EDUCATION & COMPETENCIES
An Associate or Bachelor degree from an accredited university or college.
Requires leadership skills/experience sufficient to assume the responsibilities of this supervisory position.
Must be able to use discretion and handle sensitive/confidential information.
The ability to evaluate and negotiate with vendors, suppliers, and contractors.
Must have organizational skills, attentiveness to detail, verbal and written communication, interpersonal, organizational and basic math skills.
Ability to effectively communicate at multiple levels in the organization.
The demonstrated ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar and punctuation.
A general familiarity with clinical trials research processes. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.
Proficiency in operating a personal computer. Must be proficient in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software.
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
Ability to work with a diverse work force.
Ability to work effectively within a team in a fast-paced changing environment.
Ability to multi-task, prioritize and meet deadlines in timely manner.
Ability to travel approximately 10%, 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 email@example.com