A global pharmaceutical company is looking to hire an experienced Clinical Study Manager on a permanent basis.
Working ideally in a hybrid model, the successful candidate will work onsite 3 days per week providing guidance and oversight to internal and external project team members for the successful management of clinical operation activities.
Key Responsibilities
* Contribute 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.
* Provide support in the preparation of clinical status updates to the Project Management Office (PMO) and to the Upper Management.
* Participate and contributes to internal and external training for clinical trials (e.g. kick-off meeting, Investigator meeting).
* Ensure appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs.
* Assist in the identification of study team protocol-specific training requirements and creates a trial-specific training plan for the study team.
* Contribute to the RFP process and participates in vendor selection.
* Oversee 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 TMF status.
* Assist 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.
* Perform 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
* Lead meetings with CROs, vendors, and multi-functional teams on a day-to-day basis to ensure quality, on budget and timeliness of deliverables.
* Review site and vendor invoices to ensure that project expenses are in accordance with work conducted.
* Review escalated issues from study clinical research associates (CRAs) to ensure adequate mitigation plans are implemented (e.g., investigational site monitoring and site audit report findings).
* Oversee in-house and vendor monitoring activities including selection of sites, identification of Protocol Deviations and implementation of Corrective and Preventive Actions (CAPAs).
* Draft, reviews and approves relevant documents including (but not limited to) informed consent, site worksheets, pharmacy manual, central laboratory manual and clinical monitoring plan along with the Program Leader's supervision.
* Oversee study centres to ensure timely execution of the clinical studies generating quality data.
* Offer clinical input/review to clinical documents (e.g., protocols, investigator brochures, pharmacy manual, clinical study reports)
* Provide clinical input in the development of case report forms, data management plan, and data listings review. Collaborates with Biometry to ensure timely data transfers for data cleaning, review and analysis.
* Contribute to the review of protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis, along with the Program Leader.
* Contribute to the resolution of escalated study conduct issues from study centers, regulatory authorities and institutional review boards (IRBs)/independent ethics committees (IECs).
* Track and assist in the development of study specific timelines, including management and mitigation of deliverables.
* Partner with Manager of Clinical Trial Material supplies to ensure timely manufacturing, packaging, labelling, and shipping of supplies are created according to regulatory/country specifications in required timeline, along with the Program Leader's supervision.
* Maintain awareness of serious adverse events that are reported and ensures SAE/ Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting to IRB/IEC and Principal Investigators, when applicable.
* Provide assistance in the management of the TMF process, including ongoing maintenance, accurate filing and administration of quality control (QC) plan.
* Ensure responses to site audits are adequately managed by designated clinical staff
* Prepare responses to internal audits, along with the Program Leader's supervision.
* Provide support to preparation of site inspections, attends site inspections, and supports responses to site inspections, as necessary
* Assist in the preparation of internal inspections, attends internal inspections, and contributes to responses to internal inspections, along with the Program Leader's supervision.
* Supervise quality of the clinical trial and ensures implementation of CAPAs to quality deviations and misconducts, along with the Program Leader's supervision.
PERSON SPECIFICATION
* Master's degree or higher-level degree in relevant discipline
* 5-8 years of experience in clinical research, including 2 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.
* Advanced 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.
For additional information, and to arrange a confidential discussion, please apply now with an updated CV.