Senior Clinical Study Manager

A global Pharmaceutical company is looking to hire a Senior Clinical Study Manager on a 15 month fixed-term contract. The ideal candidate will be available to start in late January 2026, and will be happy to work in a hybrid capacity. This is an excellent opportunity to join a growing team with a great work culture. 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.What you should bring to the role: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.