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 timelines.
Where applicable, act as a Country Lead for projects with no regional Lead assigned.
Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
Review, prepare and negotiate site contracts and budgets with sites.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Distribute completed documents to sites and internal project team members.
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.
Perform quality control of documents provided by sites.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Ensure regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines.
Ensure monitoring measures are in place and implement contingency plan as needed.
May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
Assist in pre-award activities including bid defenses, proposals and oversights of the scope of work at country level.
May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF.
May act as mentor, and prepare and deliver country-specific training, for less experienced staff.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Effective communication, organizational and planning skills
Ability to work independently and to effectively prioritize tasks
Ability to work on multiple projects
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Fluent languages skills in German and good command of English.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s Degree or apprenticeship in life science or a combination of education and experience; or a background in law or economics and contracting experience.
For a Junior Specialist position at least a training in clinical research or law; for a Specialist role at least 3 years of regulatory start-up / submission experience, for a Senior Specialist position at least 5 years of experience.