Chef de projet Operations cliniques / Clinical operations Project manager
LKV2023-001-CPClinOps
Paris

Full Time

LinKinVax is developing a unique and innovative vaccine platform to accelerate the delivery of safe, effective and scalable vaccines, based on the work of the Vaccine Research Institute (VRI), a French laboratory of excellence created in 2011. This DC Targeting vaccine platform is universal and adaptable to changes and mutations in target pathogens.

Five vaccines will be offered to the market over the next five years, including a vaccine already in clinical trials for HIV in 2021, and two vaccines that will be in clinical phase in 2023 (SARS-CoV-2, HPV-related cancer). In addition, LinKinVax supports upstream research to adapt its platform to new pathogens.

LinKinVax is the result of the association of leading French scientists and entrepreneurs and benefits from a portfolio of 10 patent families extended internationally.

For more information, please visit https//:www.linkinvax.com

Our company is now recruiting an experienced Clinical Operations Project Manager who will support the implementation of the clinical development plan and will report to the Director of Clinical Operations and be part of the development team.

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Mission

The LinKinVax Clinical Operations Project Manager will manage a portfolio of clinical trials in collaboration with sponsors and various academic, hospital or private partners, as well as with internal teams on all trials, from feasibility to closure, whether they are clinical operations with academic or industrial promotion. He/she will develop, implement and coordinate trials in a transversal manner with multidisciplinary teams (CRA, TEC, DM, stat, medical writer, regulatory affairs officer, coder, etc.) as well as with healthcare professionals, ensuring compliance with regulations, budgets and deadlines.

He/she will manage all the missions inherent to this function, directly or with internal or outsourced resources, from the implementation/design to the closing of the projects.

 

MAIN ACTIVITIES

Conduct / Validation of the feasibility of clinical study protocols:

  • Planning and Coordination of each study, monitoring and control of resources, budget, schedule, deliverables and KPIs related to the projects
  • Responsible for the identification and follow-up of partners (CROs and others): validation of specifications/contracts, selection and management of participants and partners
  • Coordination of activities related to the preparation of test documents, submissions, monitoring, data management and statistical activities
  • Coordination of stakeholders and partners for deliverables in accordance with schedules and budgets
  • Coordination of the management of the project’s products/drugs: interface with the regulatory authority and the responsible pharmacist for the release of batches, supply and restocking, follow-up, destruction…) in collaboration with the CRO, or the Sponsor,
  • Training of the teams in the studies entrusted to them
  • Reporting
  • Organization and facilitation of national or international meetings (KOM, DSMB, data review meeting …)
  • Identification and evaluation of potential risks and problems, and implementation of corresponding action plans
  • Risk assessment and implementation of a risk management plan
  • Participation with the quality team in the implementation of a quality monitoring plan
Job profile

Scientific background, with a specialization in Clinical Research.
4/5 years of higher education in life sciences or clinical development: Master’s degree in biology and health or drug sciences with a specialization in clinical trials and drug development / research and engineering in biosciences / research and development … , Pharmacist with a research option or industrial sector ….

Proven professional experience in clinical research, as defined below, acquired in a CRO, pharmaceutical laboratory or biotechnology company.

Clinical Research Experience:

  • Clinical Research Associate: minimum 3 years followed by minimum 5 years as a Clinical Project Manager
  • Experience in early phase research essential, phase 1 and 2 of academic and industrial trials conducted in France and in an international environment
  • Therapeutic areas: oncology, infectious diseases
  • Interactions as a sponsor or in an academic promotion context
  • Experience in the field of biologics, in the vaccine sector would be a plus

 

KEY SKILLS

Cross-functional project management (clinical development, regulatory affairs, public affairs, CMC, quality, etc.) in multidisciplinary teams

Clear and structured oral and written communication

Sense of priorities and organization within and between projects

Ability to adapt and manage change flexibly

Experience working in matrix and international organizations

Fluent in French and English, both written and spoken, covering the field of clinical operations

Scientific rigor, excellent organizational and communication skills, autonomy, anticipation, with a recognized ability to analyze and summarize

Knowledge of and compliance with international regulations (GCP, ICH…).
Mastery of office automation tools (Outlook, Powerpoint, Excel, Word, and even Access)

Ethics

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