Regulatory & Start Up Specialist 1 (f/m) - office based in Brussels, fixed term 6-12 month
Closing Date: 28 Mar 17
Type: Full Time
Salary (£): Negotiable
PURPOSEPerform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements andcontractual/budgetary guidelines. May participate in feasibility and/or site identification activities. ...
Perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and
contractual/budgetary guidelines. May participate in feasibility and/or site identification activities.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU
- Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to
- standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project
- Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
- Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Review, prepare and negotiate site contracts and budgets with sites.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory,
- ethics ICF and IP Release documents, in line with project timelines.
- Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
- May perform Site Selection Visits if a trained monitor.
- May participate in feasibility and/or site identification activities.
MINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelor?s Degree in life sciences or a related field and 1 year?s clinical research or other relevantexperience; or equivalent combination of education, training and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Effective communication, organizational, planning and interpersonal skills
- Ability to work independently and to effectively prioritize tasks
- Ability to work on multiple projects
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Knowledge of applicable regulatory requirements, SOPs and company?s Corporate Standards
- Understanding of regulated clinical trial environment and knowledge of drug development process
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.