The Data Management, Project Manager (DMPM) 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 for data management and may include statistics and medical writing activities. Acting as the primary contact for the customer for all delivery activities, the DMPM is also responsible for the budget, scope management, timelines, delivery efficiency, and quality of the projects they are responsible for managing.

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:

  • Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality, and budget
  • 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 department director and project team
  • Coordinate project requirements with clinical partners and third-party vendors
  • Performs project forecasting of hours and identification of resource requirements and manages project budgets including identification of out of scope work and participation in the contract modification process
  • Mentors junior level staff and peers on all associated tasks within a study or program
  • Identify training and development needs and liaise with line managers to ensure project team skills are appropriate for successful delivery
  • Ensure deliverables are met on time and delivered to quality standards
  • Ensure that key project documentation and project files are maintained and up to date
  • Understand at an advanced level and adhere to quality and regulatory standards (GCP, 21 CFR part11 and customer procedures) and MedSource SOPs and processes
  • Share EDC expertise with project teams, customers, sites, and other users
  • Represent the department in audits, where required
  • 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 study metrics are kept up to date
  • Participates in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required
  • Participates in the development and implementation of processes, procedures, and training for the data management function as directed, and facilitates appropriate changes to promote best practice throughout the business
  • Perform other reasonable tasks as requested by management

MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:

  • Bachelor’s Degree, preferably in Life Sciences, Computer Science, or other related scientific discipline
  • 8 – 10 years’ experience in data management at a pharmaceutical, biotech, or research facility
  • Relevant experience in a project management role managing multiple projects through the full project lifecycle within the pharmaceutical industry, preferably at a CRO

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
  • Manage multiple projects to tight deadlines and to budget and high quality
  • Excellent organizational and planning skills; 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
  • 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
  • Embraces and demonstrates company values (teamwork, trust, clear leadership and direction, quality – resulting in ‘happiness’)
  • Thorough knowledge of the end-to-end reporting process (data management, statistics, medical writing)
  • Electronic data capture software set-up and end user experience

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
  • 15-20% Travel Required

MedSource is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

 

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