The Project Manager (PM) has overall responsibility for the successful planning, execution, monitoring, control and closure of multiple projects. These projects will be managed from initiation to close-out and will cover data management, statistics and medical writing. Acting as the primary contact for the customer for all delivery activities, the PM is also responsible for the budget, scope management, timelines, delivery efficiency and quality of the projects they are responsible for managing.

The PM will have a broad understanding of clinical trials methodology and regulatory requirements and a good knowledge of electronic data capture implementation and project management tools.

Existing processes should be proactively challenged by the PM to ensure the team is working in the most efficient way possible. They should also facilitate any appropriate changes to promote best practice throughout the business.

This role requires strong team leadership skills as team motivation, direction and focus are essential to the success of any project. In addition to this, high levels of collaboration within and between departments are expected, including exceptional communication and team working skills and the ability to engage with internal and external customers. Customer satisfaction, referrals and repeat business play a large part of the role.

The PM will share their knowledge and experience with members of the project team to help broaden their commercial awareness and competency.

 

DUTIES AND RESPONSIBILITIES:

  • Lead, encourage and support cross-functional project teams to deliver to requirements, budget and deadlines
  • Communicate frequently with internal project teams regarding scope, requirements, timelines, milestones and customer relationships
  • Identify training and development needs and liaise with line managers to ensure project team skills are appropriate for successful delivery
  • Lead project kick-off meetings, establishing clarity of customer requirements and project plans, providing expert guidance to customers throughout the set-up phase
  • Establish and develop strong customer relationships throughout the life of projects, managing expectations and conflict
  • Communicate frequently and responsively with customers and clinical partners regarding timelines, requirements and scope, providing formal status updates and instigating frequent and proactive contact
  • Engage with customers to ensure a positive and stress-free customer and site experience via a consultative and risk management approach
  • Keep abreast of project status and ensure delivery requirements and deadlines are clear and achieved via frequent communication with project teams
  • Escalate significant issues promptly to senior management and/or account management
  • Coordinate project requirements with clinical partners and third party vendors
  • Ensure that project documentation is created and updated, e.g. EDC Delivery Plan, technical specifications, Statistical Analysis Plan, Clinical Study Report
  • Ensure deliverables are met on time and delivered to quality standards
  • Ensure that key project documentation is quality controlled
  • Ensure project files are maintained and fully traceable
  • Share EDC expertise with project teams, customers, sites and other users
  • Represent the department in audits, where required
  • Understand at an advanced level and adhere to quality and regulatory standards (GCP, 21 CFR part11, customer procedures and Datatrial procedures)
  • Provide user feedback to the R&D function for the product roadmap
  • Manage project budgets and scope, conducting frequent project reviews to ensure profitability is maximized and provide management information
  • Forecast, manage and adjust resources required to meet project deadlines and invoicing milestones
  • Provide project teams with budgeted hours for project activities and clear expectations of productivity requirements and monitor and provide feedback on observed performance, taking proactive and remedial action
  • Drive the accurate assessment, communication, implementation and delivery of scope changes (e.g. protocol amendments)
  • Assess resource requirements are provided by project functional leads
  • Identify, mitigate and monitor project risks
  • Conduct project lessons learned reviews at appropriate stages in projects and ensure actions are addressed
  • Proactively identify improvements and solve problems or instigate solutions using a logical and systematic approach
  • Ensure that project management systems and status sheets are kept up to date
  • Assist business development activities via expert technical input (e.g. bid defense meetings)
  • Perform other reasonable tasks as requested by management

MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:

  • Relevant experience in a project management role managing multiple projects through the full project lifecycle within the pharmaceutical industry, preferably at a CRO
  • Qualified to an appropriate standard, preferably to degree level in a life sciences or technical subject

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

  • Leadership of project teams including experience of facilitating and encouraging global and/or virtual teams and maintaining effective relationships and gaining trust
  • Excellent customer focus and sees things from customer’s perspective
  • Adopts a right first time attitude
  • Manage multiple projects to tight deadlines and to budget and high quality
  • Excellent organizational and planning skills and flexible and adaptable to change
  • Excellent prioritization of tasks and resources
  • Solution-focused, initiative, good judgment and effective decision making and problem solving through consulting
  • Risk management
  • Team orientated and ensures that self and others deliver on commitments; shares best practices
  • Committed to delivery with a high sense of urgency, drive and resilience
  • Good negotiation and influencing skills
  • Learns quickly, asks questions and applies knowledge
  • Effective and proactive written and verbal communication
  • Demonstrates and generates enthusiasm in day to day work
  • Ability and willingness to travel locally and internationally
  • Embraces and demonstrates company values (teamwork, trust, clear leadership and direction, quality – resulting in ‘happiness’)
  • Ambassador for Datatrial
  • Thorough knowledge of the end-to-end reporting process (data management, statistics, medical writing)
  • Broad understanding of clinical trials methodology, terminology and regulatory requirements
  • Good understanding of electronic data capture system set-up and use
  • Electronic data capture software set-up and end user experience
  • Third party vendor management
  • Project management software experience (MS Project or other)

CONDITIONS OF EMPLOYMENT:

  • Verification of educational requirements, employment history, professional references, and certifications/training.

WORKING CONDITIONS AND PHYSICAL EFFORT:

  • Work is normally performed in a typical interior/office work environment
  • % of Travel Required- 10-15

 

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