Clinical Research Project Manager - CB0321

TheClinical Research Project Manager takes in charge every step of the clinicalresearch projects (lead, design, setup according to procedures, initiation,operation and closure) involving internal and external parties. He/she ensuresdeliverables are achieved and budgets met. He/she also provides specificexpertise and know-how in clinical research/biobanking.
1A-B, rue Thomas Edison, Strassen 1445, Luxembourg
04/05/2021 11:48:44

Key Accountabilities
  • Support private sponsors, researchers and investigators from other research institutions or hospitals in the setup (contract, admin, approvals, timelines, budget, etc.) and conduct of clinical research projects.
  • Prepare estimates and quotations.
  • Be the main point of contact for the various partners involved in projects including clinicians and researchers.
  • Coordinate and manage a portfolio of life science/clinical research projects according to the contract/scope of work, protocol, budget (setup financial contracts and manage financial aspects during the projects) and fixed timelines.
  • Supervise and assist in the regulatory submissions (national and international to health authorities and the national research ethics committee) according to the applicable laws, administrative and regulatory requirements and obtain approvals.
  • Coordinate biobanking operations (conducted by IBBL departments) and clinical research operations (conducted by nurses, CRA, data monitors) including interacting with CCMS (methodology and statistics).
  • Track and report on deliverables/timelines, and costs vs. budget.
  • Oversee the correct implementation of the data monitoring process.
  • Participate in the quality procedure (evaluation process, drafting procedures, etc.), implementation of SOPs (Standard Operating Procedures) and their validation process.
  • Participate in European consortia and grant applications.

KEY SKILLS, EXPERIENCE AND QUALIFICATIONS
Required:
  • Master’s degree in the field of Medical/Health, Biomedical, or Life Sciences or pharmacy or Biology/Biotechnology related sciences.
  • At least 3 years relevant job-related experience in project management or clinical research or biobanking.
  • Ability to drive projects forward focusing on the deliverables.
  • Ability to interact positively with advisors and regulatory authorities.
  • Independent and multidisciplinary team working abilities, meticulous, attention to detail, clarity, accuracy, motivated, creative and scientifically innovative.
  • Strong oral and written communication skills, be able of summarising ideas and prioritising.
  • Good negotiation skills and diplomatic skills to push projects firmly but diplomatically to get results.
  • Language skills: Fluent in French and English. Any other commonly spoken language in Luxembourg such as Portuguese, German or Luxembourgish would be an added advantage.
  • Good knowledge of MS Office (Word, Excel, PowerPoint).

KEY SKILLS, EXPERIENCE AND QUALIFICATIONS
Desirable:
  • Experience in the domain of clinical research or biobanking (CRO, clinical trial unit or research centre, pharmaceutical industry).
  • Experience in multi-center international clinical projects.
  • Knowledge of the clinical research working rules in Luxembourg/Belgium and Europe (legal context, patient rights, data protection, etc.) and the international directives (International Conference on Harmonization - Good Clinical Practice: ICH-GCP) as well as the Clinical trials - Directive 2001/20/EC replaced by the Clinical Trials Regulation and biobanking recommendations and guidelines (ISBER; etc.).
  • 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).

REF.: CM/CRPM0321/CB/CMPO
2 year fixed-term contract, full time, start date immediately