Company description

Consultys, the market reference in pharmaceutical and biotech consulting

Consultys, a national and international partner, has more than 360 employees working on major projects for the world’s leading pharmaceutical and biotech groups.
Driven by a company philosophy based on human values, proximity and professional excellence, Consultys offers the resources to help every individual to achieve optimal performance.

Job description

ABOUT US: For nearly 15 years, the largest laboratories in the world have been showing their confidence in our company. Specialized in pharma, biotech and medical devices, we support our customers from research to product launch.  
 
We cultivate a human-scale company spirit that allows us to personally follow our 360 employees – each of them known for their technical and scientific expertise. Through our regional subsidiaries in France, Belgium and Switzerland, we offer everyone geographical stability, without a mobility clause in the contracts.   

JOB DESCRIPTION:

CONSULTYS BENELUX is looking for a Clinical Support Specialist to reinforce its Consulting team. As a consultant you will bring your expertise to our customer team. For this particular project, the main objectives are: 
 

• Provide operational support to Global Clinical Project Management (GCPM) to deliver projects within planned timelines and according to the required standards of quality and compliance 
• Develop TMF Plan, conduct ongoing and final QC checks of TMF for sections owned by GCPM; providing CRO or Partner with queries/feedback to ensure correctness and completeness of documents and of TMF overall 
• Provide support to COL/CPM for setting-up studies in the Clinical Trial Management System (CTMS), provide information to CTMS team to ensure data fields owned are kept up to date 
• Conduct ongoing and final QC checks of the CTMS, liaise with Partners/CPM to provide feedback and ensure resolution of issues 
• Liaise between Partners, CPM, Study Physician, QA and Legal on local Informed Consent questions and ensure fast resolution 
• Check Data Standard COA Repository and liaise with CPM and OC to identify vendors and obtain licensing agreements 
• Responsible to manage the Letter of Authorization/Delegation of Authority/Power of Attorney process and obtain LOA/DOA/POA signatures for GCPM 
• Manage Activity Notification Form (ANF) process and reconciliation for study specific activities that is out of scope for the Partner (e.g. Data Review Boards, KOL interaction) 
• Request the set-up of study mailboxes for all studies and ensure access management 
• Request and review the aggregate financial reports for studies managed by GCPM from Compliance and highlight any significant payments to COLs and CPMs.
• Assist COLs and CPMS with documenting due diligence to mitigate potential bias  Perform spot checks on Site Regulatory Packages (SRP), Form FDA1572s and PI CVs as necessary 
• Drive the implementation of new technologies/systems in clinical trials managed by GCPM 
• Act as subject matter expert on systems and continue to find efficiencies between systems and Partner systems (e.g. IMPACT, TMF, Mikado, U Pilot, SharePoint) 
• In collaboration with CPM, support audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner 
• Participate in Clinical Study Team meetings and/or other trial-related meetings when their specific expertise is required 
• Contribute to process improvement initiatives and share best practice experience   
• Occasional travel may be required 

 
START DATE: asap  WORK LOCATION: Walloon Brabant, Belgium 
 
ABOUT YOU:   

• Bachelor’s (+experience) or master’s degree (+a previous experience or internship) in Life Sciences 
• Knowledge of clinical development environment required
• Experience with Clinical trial set-up and document review is an advantage 
• Ability to proactively analyze and challenge processes and propose solutions 
• Ability to learn and master new technologies and systems and train colleagues on technologies and systems 
• Good verbal and written English and French language skills 
• Knowledge of GCP and ICH Guidelines, FDA and/or EU regulations 
• Positive attitude towards Change Management 
• Basic knowledge of medical terminology 

Searched Profile

BSc or MSc biomedical Sciences, other diploma in Life sciences will also be considered (pharmacy, biomedical, clinical...)

We offer

Do you want to integrate the consulting world into a human-sized company that values the individual and the performance? Do you want to invest in long-term innovative projects? To share your skills in a close-knit team where experiences are shared freely? 

So, join us! We offer you an attractive salary and fringe benefits (company car + fuel card, RTTs, 13e, 14e, chèques repas + ecochèques, ADV, assurance groupe, frais de représentation net)

You will work in a stimulating international environment, with numerous opportunities for personal development. 

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