Project Manager II
Summary of Job Responsibilities:
The Project Manager II 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, and medical writing. Externally interfaces with the sponsor and external vendors.
- Responsible and accountable for multiple clinical trial(s).
- Manages the project(s) within the approved budgets and timelines. . Proactively recognize any change in scope and collaborate with Business Development to ensure timely completion of change orders.
- 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.
- Act as the key client contact on assigned projects and develop successful working relationships with client to help secure repeat business.
- 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.
- 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.
- 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.
- With oversight from the Director, Project Management, the Project Manager II will assist with the training of less experienced Project Management staff.
- Participate in Business Development Activities, as appropriate.
- Education Requirements: BS/BSc/BA, preferably in a science or CRO/pharmaceutical industry-related discipline.
- Work Requirements: At least 3 or more years of CRO-specific or pharma related experience, or equivalent. Two or more years of Project Management or Management experience 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.
- 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 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.
- Qualified candidates will have the ability to mentor and delegate.