Sr. Project Manager, Phase IV and RWE

Job Overview:

Overview

Please note, this is a fully remote position.

At times working under the direction of a Project Director; the Senior Project Manager oversees and manages domestic, regional and/or global projects. Responsibilities typically include developing and managing project teams, communications, risk, scope, schedule, cost, quality, and stakeholders, effectively ensuring that variance from plan is proactively and effectively mitigated and client expectations are met. The Senior Project Manager is expected to have a working knowledge of drug development and clinical trial execution. They also compile and drive documentation for the project, ensuring the accuracy and quality of regulatory data. The Senior Project Manager may also have line management and / or business development responsibilities

Operational delivery
  • Accountable for project delivery with regards to agreed time, scope, cost and quality
  • TEAM COMMUNICATION: Serve as key client contact for assigned projects, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
  • Lead core project team(s) and facilitate team's ability to lead extended project team(s), ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders. Depending on size and scope of project(s), this job duty may be performed in collaboration with a Project Director
  • Serve as escalation point for project issues to internal and external stakeholders, as appropriate
  • TEAM COMMUNICATION: Proactively identify and resolve conflicts as needed
  • COST: Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s)
  • SCOPE: Deliver project(s) to scope, schedule and costs, ensuring all remain on track with the contract and with financial performance targets. Initiate and implement appropriate actions to proactively manage the change control process both internally and externally
  • RISK: Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Covance and client requirements
  • QUALITY: Create and manage variance to required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary. Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member's respective supervisors
  • Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract
  • Define and manage project resource needs and establish succession plans for key resources

Business Development
  • In collaboration with relevant departments, prepare and deliver presentations for new
    business as required

Perform other duties as assigned by management

Travel:Up to 30% travel required both domestic and international including overnight stays.

Education/Qualifications:

Required:
University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution

Preferred:
Master or other advanced degree
PMP certification

Experience:

Minimum of seven (7) years of relevant clinical research experience in a pharmaceutical company/CRO, including at least two (2) years of full project management responsibility

On the Job Experience:
  • Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
  • Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)
  • Experience managing projects in a matrix and virtual environment
  • Excellent communication, planning and organizational skills
  • Demonstrated ability to lead by example and to encourage team members to seek solutions
    independently
  • Demonstrated ability to handle multiple competing priorities and to utilize resources
    effectively
  • Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
  • Financial awareness and ability to actively utilize financial tracking systems
  • Good knowledge of project management processes
  • Ability to work independently and mentor junior project team members
  • Ability to negotiate and liaise with clients in a professional manner
  • Ability to present to staff at all levels


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