Internally, the Senior Project Manager interfaces with clinical monitoring and site management, clinical data management, SAS programming, biostatistics, pharmacovigilance, and medical writing. S/he also interfaces internally with business development, corporate compliance and company leadership, and externally with sponsors and external vendors.
Primary Duties + Responsibility:
- Responsible and accountable for one or more projects.
- Manage assigned projects from start-up to closeout within the approved budgets and timelines.
- Proactively recognize any change in scope, and work collaboratively with contracts and Business Development to develop and ensure timely completion of change orders.
- Develop detailed project plans and timelines and prioritizes the tasks within the plan to achieve project goals. Leverage resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables. Responsible for overseeing production and ensuring the quality and timeliness of project deliverables.
- Responsible for effective communication within the project team and with functional management.
- Provide regular updates regarding the status and progress of the projects.
- Act as the key client contact on assigned projects and develop successful working relationships with client to help secure repeat business.
- Participate in qualified vendor selection and manage vendor activities.
- Coordinate and provide oversight of all elements of the project lifecycle from initial set-up to final invoicing.
- Responsible for the identification of project risks and the development and implementation of the mitigations for these risks.
- Represent the clinical project team at investigator meetings and support meeting coordination.
- Responsible for ensuring the project is “audit ready” at all times (project team training records, central files, system validation, etc.).
- Demonstrate thorough knowledge of and coach others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
- Provide guidance and mentorship to less experienced Project Management staff.
- Participate in Business Development Activities. May also provide support in the review and development of proposal budget quotes and strategy.
- Take a leadership role in department continuous improvement initiatives.
- Execute other duties as may be required by the members of the Veristat Management team as training and experience allow.
- Strive to consistently uphold Veristat core values.
Experience & Minimum Requirements:
- Bachelor’s degree in life/health sciences or related discipline, or equivalent required.
- 6 to 8 years of relevant clinical research experience in a Clinical Research Organization/Pharmaceutical Company, with a minimum of 3 years of Project Management experience in a CRO or pharmaceutical company required. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by case basis.
- Familiarity with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
- Excellent clinical trial project management, written and oral communication, organizational, and interpersonal skills are required.
- Proficiency in English (written and verbal).
- 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.
- Ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members.
- Ability to mentor and delegate.