Clinical Project Manager

The Project Manager leads the Parexel and Sponsor teams by combining a depth of clinical research experience and project management skills with insight into sponsor pressures and an ability to develop the right solution for each sponsor. This requires in-depth business understanding, knowledge, experience and flexibility to make informed and effective decisions independently. By providing overall leadership of EP clinical trials or programs, the Project Manager ensures the project teams achieve operational excellence and successful execution of the clinical operations and logistical strategy. The Project Manager is accountable for the successful delivery of projects/programs (on time, on budget, to the highest quality) compliant with ICH, GCP, and other applicable documents and regulations.

The Project Manager is accountable for the financial aspects of project(s) including input into revenue recognition, milestone payments, and monthly pass through invoices. Fully understands and ensures compliance with relevant SOPs, contract terms, system requirements and metrics. The Project Manager
oversees Project Assistants to assure development of the project plan, team lists, and maintenance of
central files /regulatory files.

Primary duties:

• Provide a central point of study contact and single point of escalation on behalf of the functional teams (clinical, data management, biostatistics, medical writing, logistics, contracts, finance, medical and pharmacovigilance)
• Proactively communicate with the sponsor and internal groups ensuring
• Prioritize effectively and respond to urgent requests within team or from sponsor
• Maintain a positive, results-orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
• Communicate to Line Managers any needs or concerns regarding level of training or performance of any team member
• Communicate fiscal, contractual, resource, deliverable and sponsor-related issues /or Regional Client Director or Sr. management as appropriate
• Accountable for sponsor satisfaction as measured by client survey responses and repeat business Pre-award Activities (as required)
• Review relevant materials (e.g. request for proposal, proposal, etc.)
• Attend strategy meetings and provide input
• Prepare for Bid Defense
• Prepare project management strategy
• Prepare monitoring and site management strategy
• Attend the Bid Defense Meeting
• Attend relevant handover meetings on award

Leadership skills that include ability to:

• Lead a virtual team across locations and cultures
• Negotiate and influence with diplomacy in order to achieve results
• Make decisions even in ambiguous situations to achieve project timelines and quality
• Proactively identify and solve problems by using a logical, systematic approach
• Conduct root cause analysis in business problem solving and process improvement development
• Gain trust and confidence with a sponsor as well as within Parexel
• Enlist the support of team members in meeting goals
• Manage multiple and varied tasks with enthusiasm, with attention to detail, strong customer focus, ability to interact professionally
• Effective time management in order to meet daily metrics or team objectives
• Personal skills that include:
• Ability to take initiative and work independently
• Ability to successfully work in a team environment
• Sense of urgency in completing assigned tasks
• Commitment to high quality work and respective consistent performance
• Excellent interpersonal, oral and written communication skills
• Independent learning ability
• Action oriented

Knowledge and Experience:

• Approximately 2 years Project Management experience with Parexel or 3 to 5 years related work
• experience in project management or related fields
• Experience as Functional Team Leader in clinical/data management/logistics functions or proven
• experience in coordinating clinical trials
• Presentation, speaking skills (business development experience desirable)
• Budget/Contract experience desirable
• Knowledge of guidelines, ICH-GCP and other applicable local and international pharmaceutical industry
• regulations
• Solid computer and internet skills including knowledge of MS-Office products such as Excel, Word,
• PowerPoint, and Project

Education:

• BA degree with 1 to 2 years related work experience as a clinical research project manager.
• Advanced degree preferred.
• Additional Business degree or PMP or equivalent an advantage
• Scientific/Medical/Pharmacology background an advantage