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.