Job Overview:
The Project Manager (PM) fulfills the requirements of managing clinical trials (typically at the country or regional level) to ensure timely delivery of project required objectives and timelines within the scope of the client agreements for assigned projects and the project budget, with quality. In doing so, the PM 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 PM 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. The PM may also responsible for Clinical Trial Management when necessary.
Job Duties and Responsibilities:
Includes duties including but not limited to those listed below:
Project Responsibilities:
61 Develops clear and measurable project management plan in conjunction with Client representative(s) and internal stakeholders.
61 Management (typically within the country or regional geography) of clinical projects including deliverables from all functional areas and vendors in accordance with contractual timelines, client specifications, quality and GCP.
61 Establishes project metrics and project report schedules with client representatives. Provides at least monthly project updates.
61 May act as the primary liaison between the project team and the client/customers and service providers.
61 Identifies critical project success factors for tracking, analysis and reporting including probability, impact and mitigation of potential project risks.
61 Manages adherence to project budget and contracts.
61 Manages adherence to project timelines and develops creative solutions to ensure on-time delivery as needed.
61 Monitors project status, budget expenditures, and identifies problems and proactively recommends solutions.
61 Coordinates assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget.
61 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.
61 Identifies out of scope work and initiates the scope change process with client representatives and internal stakeholders.
61 Ensures the site contract and budget negotiation process is completed in accordance with project timelines and cost parameters.
61 Responsible for review and approval of project grants, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members.
61 Accountable for development, oversight and delivery of project team training.
61 Determines needed project processes, trains and maintains project team knowledge/application of project processes.
61 Establishes and communicates team performance expectations and guidelines.
61 Manages performance of all service providers, delegating appropriate and challenging assignments to encourage growth, development and responsibility.
61 Assume Clinical Trial Management responsibilities for applicable study or country, if applicable.
Organization/Departmental Responsibilities:
61 Provides performance evaluation input for the Company project team members and service providers.
61 Reviews and complies with the Company Standard Operating Procedures (SOPs)
Business Development Responsibilities:
61 Collaborates with assigned the Company team members in the preparation of bid defense materials and presentation of project management capabilities at bid defenses.
Supervisory Responsibilities:
No supervisory responsibilities.
Job Requirements:
61 Education:
o Bachelor’s degree required; PMP certification/advanced degree or equivalent clinical research experience a plus.
61 Experience:
o At least one year of clinical project management experience or equivalent combination of education, training and experience in clinical research industry.
o 5+ years of clinical research background, including medical and/or scientific experience is preferred.
61 Skills/Competencies:
o Successful project management skills - demonstrated ability to successfully manage people/projects. Proactive problem-solving abilities and follow through. Highly self- motivated and proactive with the ability to work independently. Sound judgement and decision making skills. Exceptional attention to detail and ability to work simultaneously on multiple priorities
o Strong leadership skills – Aligns goals for self, team and department with the goals of the Company. Builds and develops unified teams that take action to achieve goals. Shows flexibility and ability to persevere as objectives change.
o Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making.
o 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.
o Financial Management – Good understanding of financial management (time and cost, forecasting, revenue recognition, margins, invoicing and utilization).
o Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Client, project team member and internal the Company relationships. Ability to conduct effective presentations.
o 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.
o Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
61 Capabilities:
o Ability to communicate in English (both verbal and written)
o Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.