Position Summary
Contributes to clinical feasibility assessment and strategic planning of clinical trials / studies assigned. Executes on assigned clinical trials / studies in one or more assigned therapeutic area(s). Provides guidance and oversight to internal and external project team members for the successful management of clinical operation activities.
Main Responsibilities
* Contributes to the oversight of integrity of clinical data, obtained from conducted clinical trials, to ensure data meets GCP standards, along with the Program Leader's supervision.
* Provides support in the preparation of clinical status updates to the Project Management Office (PMO) and to the Upper Management.
* Assists PL in assessing best strategic path forward for a clinical trial / study and contributes to clinical strategy recommendations.
* Manages direct reports through performance evaluations and addressing professional development.
* Participates and contributes to internal and external training for clinical trials (e.g. kick-off meetings, Investigator meetings).
* Ensures appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable).
* Assist in the identification of study team protocol-specific training requirements and creates a trial-specific training plan for the study team.
* Contributes to the Request for Proposal (RFP) process and participates in vendor selection.
* Oversees third party vendors performance.
* Assists in evaluation of vendor performance to ensure early mitigation/resolution of potential issues and serves in key role to develop/implement corrective action plans as appropriate.
* Performs Sponsor Site Visits at selected sites to oversee the site and the monitoring performances.
* Oversees in-house and vendor monitoring activities including selection of sites, identification of Protocol Deviations and implementation of Corrective and Preventive Actions (CAPAs).
* Drafts, reviews and approves relevant documents.
* Oversees study centres to ensure timely execution of the clinical studies generating quality data.
* Provides clinical input in the development of case report forms, data management plan, and data listings review.
* Provides assistance in the management of the TMF process, including ongoing maintenance, accurate filing and administration of QC plan.
* Ensures responses to site audits are adequately managed by designated clinical staff.
* Contributes responses to vendor/site audits, along with the Program Leader's supervision.
* Prepares responses to internal audits, along with the Program Leader's supervision.
Qualifications
* 8+ years of experience in clinical research, including 3 to 5 years in a study management/leadership role.
* Strong leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel.
* Bachelor's degree in relevant discipline.
* Strategic thinking abilities for proactive planning and decisive decision making.
* Advanced ability to set and meet deadlines, multitask, and prioritize based on program and/or study needs.
* Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings. Advanced ability to train and mentor CRAs.
Dublin, County Dublin, Ireland
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