Senior Project Manager

Group: Project Management

Reports to: Senior Director, Project Management

The Senior Project Manager provides management and leadership to plan, prepare and execute multiple high quality clinical projects and/or programs.   Responsible for managing more complex and high profile clinical projects and/or programs. 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, medical writing, finance, and business development. Externally interfaces with the sponsor, and external vendors.

Responsibilities Include:

• Responsible and accountable for multiple clinical trial(s).
• Manages the project(s) within the approved budgets and timelines.
• Develops detailed plans and timelines and prioritizes the tasks within the plan to achieve project goals. Adjusts plans in a timely manner in response to client and internal needs.
• Maintains and updates timelines and notifies internal team and external team regarding required timeline adjustments.
• 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 regular updates regarding the status and progress of the trials to the client and the internal and external team as needed.
• 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, including any external integrations.
• For paper based trials, manages the complete project development process, from initial setup through database lock, including development of case report form (CRF) 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.
• Responsible for vendor management, including IVRS.
• Supports the coordination and attends investigator meetings, representing the clinical project team.
• For trials that have Data Monitoring Committee (DMC), works closely with the sponsor, biostatistician, and other relevant personnel to develop the DMC Charter, select committee members, and convene, provide reports to, and disband the DMC.
• For trials that have a monitoring and/or safety component, works closely with the relevant personnel to ensure project goals are met.
• 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.
• Provides guidance and mentorship to less experienced Project Management staff.
• Assists with the strategic long-term planning for the Project Management department.

Minimum Requirements

• Education Requirements:  BS/BSc/BA, preferably in a health, science or CRO/pharmaceutical industry-related discipline.
• Work Requirements: 4 or more years of Clinical Project Management, or relevant Management work experience required; 2 or more years as a Senior Project Manager in a CRO preferred.  Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by case basis.
• Skills:  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 and lead 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