Clinical Project Leader

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What we offer

Joining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

 

Job Description

Keyrus Life Science is looking for a Clinical Project Leader to join our consulting team for a client project based in Liège. 

Your challenges will be : 

  • Participate to the CRO selection process by reviewing all related documents (i.e. RFP documents …).
  • The CPL selects CRO/third parties in collaboration with the CTM/COM.
  • Verify that all 3rd party vendors that have been contracted directly by the sponsor have been audited/qualified. 
  • Collaborate with the CTM to make sure the partner is qualified by the QA department prior to the study start
  • Coordinate the preparation of all study related documents, such as the protocol synopsis, clinical study protocol, ICF, (e)CRF, project plan, insurance, Clinical Study Report … and review the main documents
  • Coordinate the development of the safety monitoring plan / safety tables
  • Collaborate with the CRO to organize the Investigator/CRA meeting by reviewing presentations or selecting meeting venues
  • Check that all activities performed by external partners (CRO, central lab, IWRS provider, …) are performed according to our client expectations, if delegated to a CSL.
  • Closely monitor all work performed by the external partners to ensure the quality of the service with respect to the mutually agreed timelines and budget
  • Ensures Site Initiation Visits and monitoring visit (usually performed by the CRO) are prepared
  • Participate to the site staff training to the use of the investigational product, to the data collection and to the study specific procedures
  • Provide all study related documentation to the CTA in a timely manner to allow the CTA to maintain the Trial Master File throughout the entire study duration and to be ‘inspection ready’
  • Demonstrate leadership and maintain a good relationship with all internal and external partners
  • Participate in all risk management meetings for each study. Ensure Risks are escalated to project and to COM if applicable
  • Develop overall budget and timelines at project level in collaboration with COM
  • Organize or facilitate the clinical team meeting with the support of the CTA/CSL/CSLa
  • Ensure a strategic planning of all clinical studies in accordance with the clinical development plan
  • Represent the clinical development in the project team meetings
  • Work closely with the COM to put in place preferential partnerships/subcontracting to establish synergies, to improve efficiency and quality for all clinical studies. Make sure the CRO tracker is kept up to date and share the information with the entire team
  • Provide support to the development of the Clinical Department by assisting in the review of SOP’s …
  • Participate to the continuous improvement of all clinical processes

Profile

  • Master in biomedical sciences or other life science degree
  • Min. 5 years experience in clinical trial related function
  • Min. 2 years experience in CRO/Vendor manager and project management

 

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skilfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.  

Additional information

  • Remote status

    Hybrid remote

Or, know someone who would be a perfect fit? Let them know!

Liège

4000 Liège Directions

Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.

What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.   

With us, you will be part of our family and feel our human approach culture as of Day 1! 

Already working at Keyrus Life Science Belgium?

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