PlusOne

Project Manager - Clinical Data - Louvain-la-Neuve

Company

Our client is a leading, therapy-focused data services CRO providing expert clinical trial services: Biostatistics and eClinical Services to ensure your clinical data is ready for submission. They combine advanced Biostatistics, regulatory and medical expertise, and innovative integrated eClinical Solutions to increase efficiency and mitigate risks throughout the drug development process.

Role

The Project Manager is the key client contact for projects. The company is performing multiple tasks (randomization & trial management systems (RTSM), clinical data management, client support and system validation, biostatistics, and/or medical writing). His/her role will be to ensure that the project is completed on time, within budget, and with high quality meeting the client’s expectations.

As a Project Manager, your key responsibilities will be to:

  • Oversee the project team providing RTSM, clinical data management and statistical analyses for clinical trials.
  • Ensure optimal relationship with clients by day-to-day communication, project meetings, reporting, and quality assurance.
  • Ensure a positive relationship between different departments to ensure optimal data processing and efficient communication.
  • Ensure that appropriate documentation is filed in the Trial Master file and that the services are produced and maintained for each project.
  • Create and maintain the project planning and ensure that milestones and Team Lists are up to date and communicate to team in case of modifications.
  • Assist Quality Assurance to prepare customer audits of their projects, and attend the audit as necessary.
  • Detect, resolve and/or escalate project problems and conflicts.
  • Review contract and budget amendments.
  • Perform regular project budget analysis in order to ensure that the project is on time and in budget.
  • Ensure that team members assigned to the project receive the appropriate project specific training.
  • Develop and update SOPs/WINs/Guidance documents with respect to Project Management processes.

Profile

  • Master’s degree in science, a health related field or biostatistics
  • At least 5 years’ experience in clinical trials
  • Good knowledge of different areas of expertise (RTSM, Clinical Data Management and Biostatistics)
  • Experience in Project Management in Clinical Research managing project teams, planning and budgets
  • Experience of at least 2 years in either Clinical Data Management or Biostatistics
  • Excellent level of leadership, self-motivation, business acumen and negotiation
  • Thorough knowledge and understanding of CROs and the pharmaceutical industry
  • Good problem-solving and interpersonal skills (communication, organizational and time management skills)
  • Commitment to quality
  • Strong independent worker and team player
  • Excellent knowledge of English, both oral and written and good communication skills
  • Ability to manage multidisciplinary project teams
  • Ability to travel to meet with clients, prospects and attend face-to-face meetings
  • Knowledge of Microsoft tools: Excel, Word, PowerPoint, MS Project

Offer

A unique opportunity to work in an innovative, dynamic and future-oriented company. A strong international environment.

Publication date

09.09.2021

Contact person

Leonard

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