JOB DESCRIPTION:

Job Title: Project Manager or Senior Project Manager
Job Location: Remote – United States or Canada
Special Note: The person hired for this position must be able to speak both Mandarin and English

JOB REQUIREMENTS:

Education

• Bachelor’s degree preferred; Advanced degree preferred or equivalent clinical research experience.

Experience

• Minimum of 2+ years of experience managing clinical trials while working as a Clinical PM or similar title and level of responsibilities at a CRO is required
• 5+ years of experience in the clinical research industry.

Skills/Competencies

• 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.

  Capabilities

• Ability to communicate in English (both verbal and written)

• Infrequent travel may be required

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JOB DUTIES AND RESPONSIBILITIES:

• Develops clear and measurable project management plan in conjunction with the Director, Clinical Operations – Project Management and Sponsor representative(s).
• Manage 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.
• 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 Caidya 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.
• Collaborates with Director, Clinical Operations, Project Management and Directors, Business Development in the development/presentation of Caidya capabilities/proposal defenses.
• Supports the development of project proposals by participating as requested. Represents Caidya Project Management at professional, marketing and new business meetings.