The Clinical Operations Manager (COM) is responsible for managing, executing, and reporting on all clinical trials conducted.
Essential Functions (Including Regulatory Requirements):
administrative aspects related to the clinical studies.
enrollment strategies to improve enrollment
and monitoring budgets
enrollment and follow-up phases of the study.
and action plans to the Sr. Director, Clinical and Data Operations.
sites for compliance resolution.
monitoring/accompanied site/visits and ongoing mentoring of CRA team.
(DSMB) preparation and conduct of the meetings.
least 2 years clinical operations management experience; or equivalent combination of education, training
requirements, i.e., ISO 14155, MEDDEV 2.7,
Informationsverordnung”, MPAMIV), and the Ordinance on Clinical Investigations with Medical Devices
(“Verordnung über klinische Prüfung von Medizinprodukten”, MPKPV).
Skills & Abilities:
planning, time management and coordination skills.
Physical Demands/Work Environment:
General Understanding Requirements:
submissions for pre-CE mark studies, PMCF studies, and IDE clinical trials (a plus).
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