Clinical Study Manager
I am recruiting for a Clinical Study Manager for a multinational pharmaceutical, they are a European leader and one of the largest globally in their field.
Clinical Study Manager
The role: Provides guidance and oversight to internal and external project team members for the successful management of clinical operation activities in accordance with International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, applicable regulatory requirements, company standard operating procedures (SOPs), and study protocols, along with the Program Leader's supervision.
Location: Dublin, Ireland. (Hybrid).
Salary: Excellent salary, bonus and benefits available. Contact John Finn for more information.
* 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.
* Participates and contributes to internal and external training for clinical trials (e.g. kick-off meeting, Investigator meeting). Assist in the identification of study team protocol-specific training requirements and creates a trial-specific training plan for the study team.
* Ensures appropriate training is conducted for clinical research organization (CRO) staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable)
* Contributes to the Request for Proposal (RFP) process and participates in vendor selection.
* Oversees third party vendors performance (e.g., CROs, central laboratories) including on time study completion, budget adherence, and quality deliverables along with the senior management. In particular it may include the review of monitoring reports, approval of clinical plans, regular review of protocol deviations and the oversight of the Trial Master File (TMF) status. Continuous monitoring of vendor activities.
* 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, to increase the communication with the site and awareness of protocol burdens. Documentation of the Sponsor Visits and follow-up of appropriate corrective and preventive actions
* Leads meetings with CROs, vendors, and multi-functional teams on a day-to-day basis to ensure quality, on budget and timeliness of deliverables.
* Oversees Clinical Trial Design/Performance. Ensures transparency in data collection, insurance certification and compliance with regulation
* Aid in the management of the Trial Master File process, including ongoing maintenance, accurate filing and administration of QC plan.
Your knowledge and experience:
* Master's degree or bachelor's degree in relevant discipline.
* Typically requires 5-8 years of experience in clinical research, including 2 years in a study management/leadership role.
* Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings. Advanced ability to train and mentor CRAs.
* Good strategic thinking skills that enable proactive planning. Good verbal, written, and interpersonal skills. Good motivational, decisive decision-making and issue resolution skills. Good ability to prioritize and effectively manage changing priorities
If you are interested in this Clinical Study Manager's position, please contact me through LinkedIn or directly to arrange a confidential follow up call: 01 645 5222, Mobile: 087 621 4254, [email protected] and 086 0257479, [email protected]