Clinical Research Project Manager

The Clinical Research Project Manager (CRPM) is in charge of the entire lifecycle of a clinical research project from the development (lead and design) up to the implementation (set-up and initiation) and execution (operation and closure). The CRPM ensures that projects are delivered within timelines, scope, and budget. For the current position, we’re looking for an experienced project manager able to coordinate large clinical study.

Key Accountabilities

• Liaise with all stakeholders (private sponsors, researchers and investigators from Research Institutions / Hospitals, administrative support teams within LIH) to shape the initial concept in line with the project originator requirements and the Translational Medicine Operations Hub (TMOH) goals/vision.
• Identify and document the project scope, risks and objectives.
• Ensure that all projects are managed according to the contractual agreements, study protocol, budget, fixed timelines and applicable policies/procedures.
• Track and report on progress, risks, deliverables/timelines, and costs vs. budget, through project management tools/templates.
• Coordinate and monitor progress of biobanking operations (inventory, processing, sample and kit management etc), clinical operations (site management and start up activities), data management and statistics activities, as well as required IT development if applicable. Make adjustments on project schedule and goals when needed.
• Evaluate project performance indicators and facilitate risk identification with the Subject Matter experts and address mitigation plans.
• Prepare cost estimates, setup financial contracts and manage financial aspects during the projects based on the scope of work/resources and quotations.
• Manage and/or support financial reporting process across different funding bodies (FNR, EU grants etc)
• Act as a liaison between internal stakeholders (eg. from biobank, data management, clinical operations, finance/accounting, legal, IT, communication etc), consortium partners (public and/or private) and principal investigators and keep them informed.
• Oversee the correct implementation of data entry and query management during the studies according to the monitoring plan.
• Participate in departmental initiatives and performance improvement activities (evaluation process, working groups, training, revision of operating procedures, enhancement of tools and Dashboards).
• Participate in European consortia and grant applications.
• Communicating with TMOH board to keep the projects aligned with goals/priorities.
  
  

Key Skills, Experience and Qualifications

Required

• Master’s degree in the field of Life Sciences or equivalent.
• At least 3 years experience in project management in clinical research or Laboratory / Biobanking.
• Ability to manage projects autonomously focusing on the deliverables.
• Ability to interact positively with advisors and regulatory authorities as well as key stakeholders.
• Independent and multidisciplinary team working abilities, meticulous, attention to detail and clarity in communication, accuracy, motivated, creative and scientifically innovative.
• Strong oral and written communication skills, able to summarise ideas and prioritising.
• Good negotiation and diplomatic skills to push projects firmly in order to get results.
• Language skills: Fluent in English and in French. German or Luxembourgish would be an asset.
• Good knowledge of MS Office (Word, Excel, PowerPoint).

Considered as an asset

• Previous experience in the domain of clinical research or biobanking (CRO, clinical trial unit or research centre, pharmaceutical industry etc).
• Knowledge of the biomedical research environment and ecosystem in Luxembourg.
• Knowledge of the clinical research working rules in Luxembourg/Belgium and Europe (legal context, patient rights, data protection, etc.), the international directives (ICH-GCP), regulatory requirements for clinical trials, biobanking guidelines (ISBER).
• Knowledge of regulatory requirements for clinical trials. Certified clinical research (DIU-FARC, DIU-TEC, etc.) or biobanking certificate. PRINCE2 or equivalent; experience in a PM tool (MS project or equivalent).