Project Manager

Group: Project Management

Reports to: Associate Director, Project Management

The Project Manager provides management and leadership to plan, prepare and execute one (or more) high quality clinical project(s). Leads the clinical project team members toward completion of deliverables in a timely fashion within an agreed project timeline. General areas of responsibility include: project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to quality standards, Standard Operating Procedures (SOPs), International Conference on Harmonisation (ICH) and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communications between the project team and sponsor, and contract and financial management.

Internally interfaces with database development, clinical data management, SAS programming, biostatistics, and medical writing. Externally interfaces with the sponsor and external vendors.

Responsibilities Include

Responsible and accountable for one or more clinical trial(s). Manages the project(s) within the approved budgets and timelines. Develops detailed plans and prioritizes the tasks within the plan to achieve project goals. Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables. Responsible for effective communication within the project team and with functional management. Provides regularly updates regarding the status and progress of the trials. Responsible for overseeing production of clinical project deliverables, including protocol, clinical study report, study manuals, study tools, operational plans, etc. For electronic data capture (EDC) trials, manages the complete project development process, from initial setup through database lock, including electronic case report form (eCRF) design and edit check design, development, and implementation. Coordinates all output development processes, database transfers, and database integrations. Responsible for the identification of project risks and the development and implementation of the mitigations for these risks. Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed. Supports the coordination and attends investigator meetings, representing the clinical project team. Responsible for ensuring the trial is “audit ready” at all times (project team training records, central files, system validation, etc.). Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.

Minimum Requirements

BS/BSc/BA, preferably in a science or CRO/pharmaceutical industry-related discipline. Two or more years of relevant work experience. One or more years of Project Management or Management experience recommended. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by case basis. Excellent clinical trial project management, written and oral communication, organizational, and interpersonal skills are required. Good working knowledge of drug development process and clinical research methods. Proficiency in English. Qualified candidates will be action-oriented and resilient in a fast-paced environment and will have the ability to build effective project teams, motivate others, delegate, and make and implement decisions. In addition, qualified candidates will have the ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members.

Submit Your Resume

If you would like to be considered for a position at Veristat, please submit your resume to Human Resources at hr@veristat.com