The Project Manager fulfills the requirements of managing clinical trials (at the country or regional level, typically) to ensure timely delivery of project required objectives and timelines within the scope of the client agreements for assigned projects and the project budget. In doing so, the Project Manager is responsible for the cross-functional team’s compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines and other applicable regulations. The Project Manager is responsible for the overall execution of the project and may be the principal liaison with the client to ensure effective and timely communication of project progress, issues and plans for resolution of those issues.
Job Duties and Responsibilities:
- Project Guidelines and Communication
- Develops clear and measurable project management plan in conjunction with the Director, Clinical Operations – Project Management and Sponsor representative(s).
- Management (within the country or regional geography) of clinical projects including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality and GCP.
- Defines timelines, milestones and scope of work limitations to project staff.
- Establishes project metrics and project report schedules with client representatives. Provides at least monthly project updates.
- May act as the primary liaison between the project team and the sponsor/customers and service providers.
- Project Analysis and Management
- Identifies critical project success factors for tracking, analysis and reporting including probability and impact of potential project risks.
- Manages adherence to project budget and contracts and assists in the identification and development of scope change documents.
- Monitors project status, budget expenditures, and identifies problems and recommends solutions.
- Coordinates assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget.
- Develops budget and expense review strategy; creates scope definition documents and creates proactive cost containment strategies and communicates with project team; regularly reviews budget/expenses with project team.
- Identifies out of scope work and initiates the scope change process with sponsor representatives.
- Ensures the site contract and budget negotiation process is completed in accordance with project timelines and coast parameters.
- Responsible for review and approval of project grants, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members.
- Accountable for development, oversight and delivery of project team training.
- Determines needed project processes, trains and maintains project team knowledge/application of project processes.
- Establishes and communicates team performance expectations and guidelines.
- Manages performance of all service providers, delegating appropriate and challenging assignments to encourage growth, development and responsibility.
- Provides performance evaluation input for Clinipace project team members and service providers.
- Participates in development and review of departmental Standard Operating Procedures (SOPs), guidelines, and intradepartmental procedures and other continuous process improvements programs, as assigned.
- Business Development
- Collaborates with Director, Clinical Operations, Project Management and Directors, Business Development in the development/presentation of Clinipace capabilities/proposal defenses.
- Supports the development of project proposals by participating as requested. Represents Clinipace Project Management at professional, marketing and new business meetings.
Supervisory Responsibilities: No supervisory responsibilities.
- Bachelor’s degree required; Advanced degree preferred or equivalent clinical research experience.
- 5+ years of clinical project management experience or equivalent applicable experience in clinical research industry, Infectious Disease/Oncology study knowledge preferred.
- Expertise in project management - demonstrated ability to successfully manage people/projects. Proactive problem solving abilities and follow through.
- Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making.
- Extensive knowledge of clinical research - Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to review protocols, programs, and assess the success of a project.
- Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, project team member and internal Clinipace relationships. Ability to conduct effective presentations.
- Computer skills - Working knowledge of MS Office suite and MS Project or equivalent. Able to generate business correspondence, create forms and generate reports as required.
- Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
- Ability to communicate in English (both verbal and written)
- Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.