Description:
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.