sCLINICAL SYSTEMS EXPERT

Business & Decision Belgium
Sint Lambertusstraat 141 Rue Saint Lambert
1200 Brussels
Belgium
Phone : +322 774 11 00
Fax : +322 774 11 99
Contact

Job detail

Functional Area:

• Data Management

eClinical Systems Services include:

• Electronic data capture (eDC) systems
• Clinical trial data captured within eDC systems
• Integration systems between eClinical Systems (eDC, electronic patient reported outcomes (ePROs), safety data management system, electronic health record systems (EHRs), IV/WRS, CTMS, Laboratory Data Management Systems, etc.)
• Clinical trial data integrated between eClinical Systems

Duties and responsibilities:

 

Clinical Development Project Responsibilities may include:

• Taking an active role on assigned Clinical Development Projects through overseeing and taking Sponsor accountability for the External Parties eClinical Services with respect to scientific/technical content, quality, budget and timing
  
  
• Taking an active role and Sponsor accountability in the screening, evaluation and selection of External Parties delivering eClinical Services for the Clinical Trials
  
  
• Review and approval of budget proposals and contracts of External eClinical Systems Partners for eClinical Services of clinical trials
  
  
• Interacting effectively with the representatives of the  functional areas (Development Project Leaders, Operational Leaders, ICT Project Leaders, Medical Leaders, Safety Officers, CTLs, Biostatisticians, Data Managers, Medical Writers, Quality Monitoring personnel, Regulatory personnel, etc.) to ensure the  eClinical Systems processes and deliveries are fully integrated with the needs of the distinct  functional areas
  
  
• Playing an active role in generic training and support/assistance of External eClinical Systems Parties in the use of specific controlled procedures, generic process flows, timelines and established specifications for eClinical deliverables
  
  
• Participating in yearly review of the External eClinical Systems Parties controlled procedures, process flows, documents and deliverables for consistency with controlled procedures (where applicable) and adherence to Regulatory requirements
  
  
• Attending or participating in meetings as appropriate
  
  
• Participating in the strategic allocation/outsourcing of eClinical Services to External Parties
  
  
• Participating in the strategic selection process of new External eClinical Sytems Parties, as well as evaluation of the quality of their work
  
  
• Taking an active role in overseeing the planning for the eClinical Services in view of submissions for all of the
  
  
• Taking an active role in design of generic documents and specifications, in particular pertaining to the generation of regulatory submission data standards (e.g. SDTM mapping in close collaboration with  Statistics and Medical, …)
  
  
• Close follow-up of the External eClinical Systems Parties resourcing capabilities
  
  
• Participating actively in the creation, review and implementation of new SOPs, Work Instructions, guidelines, processes, documents and other tools to ensure efficient and compliant eClinical Services delivered by the External eClinical Systems Parties

Job requirement

Experience/Skills/Competencies:

• Outstanding written and oral communication skills
• Excellent organizational skills and demonstrated ability to manage projects
• Experience in effectively prioritizing and managing multiple tasks simultaneously
• Excellent interpersonal skills
• Effective problem solving & negotiation skills
• Highly motivated and creative
• Excellent team player
• Able to plan work to meet deadlines and work under pressure
• Accurate, conscientious and thorough
• With preference 5 years of experience in Clinical Drug Development within the Pharmaceutical Industry or related Industry; or with proven professional track record.
• Medical domain: infectious diseases
• In depth understanding of current clinical drug development processes and regulatory requirements
• Knowledge of applicable international guidelines regarding eClinical Systems for clinical trials
• Excellent knowledge of English, both spoken and written
• Knowledge of eClinical Systems (eDC, ePRO, Electronic Health Records, etc.)
• Knowledge of technology platforms for data exchange and integration
• Knowledge of Clinical Data Management Systems (CDMS)

Education:

 

University degree – medical, paramedical (pharmacy, biology, veterinary, etc.), technical (engineering, …) or equivalent by relevant work experience.