Pharmaceutical Research Associates, Inc - Spain Negotiable Full-Time 1 position Overview: ICON plc is a world-leading healthcare intelligence and clinical research organization.
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Responsibilities: The Associate Director Clinical Trials (ADCT) is responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects.
This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs.
S/he performs activities related to the heading of a project team, the supervision/control of third-party providers, the timely performance of all services, as well as problem management by interacting with all departments involved.
Proven success in the oversight and delivery of outsourced clinical trial deliverables.
Support in preparation of regular status reports to SDCO and ADCT / Chief Medical Officer (CMO), including presentation of project status in meetings.
Overlooking the clinical operation trial budget.
Opportune contact with PM and ADCO in case of divergences from the project plan.
Oversight on project timelines and deliverables.
Set-up or oversight of study-related documents such as Study Management Plan, Monitor Manual, etc.
Contribution to and review of study core documents, e.g., synopsis, investigator's brochure, patient informed consent documents, etc.
Supervision/quality control of the project team member's adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective training.
Co-ordination of project activities with other sponsor departments.
Instruction and supervision of CTCs, CRAs, and CTAs (in the scope of a project).
Point of contact in case of problems within the clinical trial.
Support in planning and conduct of project training prior to starting project activities, oversight if project team has appropriate trainings and report training needs to the ADCO.
Organization and conduct of study team meetings.
Review of all clinical trial activities from start-up to close out.
Responsibility for oversight of the Trial Master File (paper or electronic) during the clinical trial and initiation or performance of regular QC checks.
Processing of all relevant issues of the national and international ethics committees and regulatory authorities in adherence to the timelines.
Support in the process of selection and decision on participation of investigator sites.
Organization and participation in investigator meetings.
Oversight and handling of contract negotiations with trial sites/pharmacies/local labs in Germany, correspondence with legal.
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