Clinical Project Manager - Vaccines Start-up
Our client is a fast-moving biopharmaceutical start-up specialized in vaccines. They are currently focused on the implementation of an influenza vaccine candidate which is currently evaluated in a phase I clinical trial, to rapidly move into phase II of the development.
You are looking for a professional challenge that allows you to work in a start-up environment in order to lead Clinical Projects ?
Working in a in Clinical Trial Activities is a great opportunity and as an expert in Vaccinology y and thanks to your experience in the industry you want to apply your competences in this field?
Plus One can offer you this great challenge:
Your key responsibilities:
- You manage project-level operational aspects of clinical trial team: trial timeline, budget, resources and vendors (oversight and coordination of activities by CROs/vendors in conjunction with the CRO’s Project Manager), at all stages of the trial
- You provide regular and efficient updates on trial progress to concerned managers, with respect to vendor appointment process, project plans, trial budget and timeline management, quality standards and risk mitigation
- As problem solver, you indentify, you escalate and propose corrective action for any significant issues which may have an immediate impact on patient safety or conduct of the study, timelines, budget, and/or data quality
- You ensure that effective study plans are in place and implemented for each trial. You set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements
- You lead sponsor study startup process: conduct of the trial kick-off meeting, Clinical Research Associate training, set-up of the trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets
- You act as first point of contact for operational questions for the given trials
- You facilitate and coordinate communication between all stakeholders involved (internal and external)
- You contribute to timely development and/or review of trial-specific documents (Informed consent form, Protocols, DSMB Charter, Case Report Form, Statistical analysis plan, clinical study report...)
- You review and approve site visit reports; ensuring tracking and follow up of action points and resolution of site issues in a timely manner
- You monitor the quality of vendor deliverables
- You review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements
- You ensure all project level study documentation is filed in the TMF in accordance with Company SOPs/all regulatory requirements
- You contribute to improve Clinical Operations Quality System: development and writing of Standard Operating Procedures (SOPs)
- Master’s degree (or PhD) in Life Sciences or Pharmacy
- At least 2 years of relevant industrial experience in clinical operations in Pharma, Biotech or CRO. An experience as a CRA, Scientific Writing or other function which permitted you to have a view on the Clinical Trial Process would be an added value.
- Previous experience in project management would be an important asset.
- Experience in the therapeutic area of vaccination and a headquarter level is an asset.
- Know-how in managing Phase I and II clinical studies from study start-up to closeout.
- You have strong knowledge in ICH/GCP guidelines and regulatory requirements
- Self-starter; able to work independently and within a multidisciplinary team in an international and multicultural environment
- Problem solver, flexible, organized and proactive, pragmatic and with scientific rigor
- Sense of urgency; able to manage multiple and varied tasks and prioritize workload with attention to detail.
- Good communication, listening and negotiation skills
- Fluent in written and spoken English at professional level. Knowledge of French and/or Dutch is an asset.
- Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 20 % of work time
- Advanced level in MS software platform
- A dynamic and ambitious work environment in a high qualified and experimented small team
- An attractive salary with extralegal benefits
- Permanent contract, Full time job (Part-time could be feasible)
- Location: Liège + 20% travelling
- Start date: ASAP