Clinical Trials Manager

Job Description

Manages the overall planning, conduct and progress of clinical studies, and clinical operation.

Responsibilities :

Project management – Matrix management

Execute clinical trials.

Manage single and multi-center clinical studies worldwide including study timelines, communication, and stakeholders management

Verify study data base integrity

Write clinical study documentation: protocols, Informed Consent, Investigator brochures, financial agreement, CRF and EDC, Submission package for IRB / EC approval, etc.

Manage clinical studies preparation and approval internal process– coordinated with stakeholders involved in the study (R&D, product management, biostatistics, data management, investigators, customer support) to execute a clinical study from planning to publication stages

Conduct and follow up on sites qualification, initiation, monitoring and close out visits

Approve and oversee study payments and payments tracking

Requirements :

3-6 years experience as a study manager (degree dependent) for medical device company or related field

Academic degree in life sciences

Extensive knowledge of ICH / GCP / ISO14155 regulations and guidelines

CRA certificate

Detail oriented and independent

Full working proficiency in English

Able to write reports and business correspondence