Responsible for providing operational and administrative support to one or more clinical functions.
Provide administrative support by coordinating documentation and communications, including maintaining and managing shared mailboxes, organizing project files, tracking action items, and ensuring timely follow-up with cross-functional stakeholders.
Enter, maintain and reconcile information in agreed project and clinical tracking systems.
Timeline and milestone tracking.
Perform document management activities including document creation, compilation, formatting, version control, and quality control (QC).
Translation of documents using approved vendors/systems.
Use AI-enabled tools, dashboards, and automated reports to provide logistical, organizational, and analytical support.
Support Trial Master File (TMF) filing and related document process activities within scope, ensuring inspection-ready documentation.
Responsible for providing quality deliverables. Follow project requirements and applicable country rules, with oversight at the project level from functional leads.
Review and comply with applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs), ensure training compliance, and maintain accurate timesheet reporting.
Monitor workload/scope, budgeted effort, and project hours; escalate discrepancies in a timely manner.
Maintains overall awareness in the field of clinical research by completing all necessary and assigned training.

Bachelor's Degree or equivalent combination of education, training and experience.
1 to 2 years clinical operations experience.
Provide operational and administrative support to CRAs and Country Regulatory Specialists within the site activation and regulatory submissions functions.
Good understanding in clinical research, drug discovery, clinical trials (setup, maintenance, closeout).
Must have good communication (Verbal & Written).
Demonstrated understanding of clinical operations and the clinical trial process.
Utilize problem-solving techniques effectively.
Skilled at proactively identifying opportunities for increased efficiency and quality.
Strong documentation and communication skills (written and spoken English) as well as a team-oriented approach.
Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Publisher) and ability to embrace new technologies and demonstrate ability to learn and adopt new technologies and tasks (including AI-enabled tools and dashboards where approved/available).
Ability to manage competing priorities and work in a dynamic fast-paced environment.
Demonstrated ability to work independently as well as part of a team.
Good organizational skills and attention to detail, proven ability to take direction from multiple individuals and set priorities accordingly.
Quality-driven in all assigned activities.
Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.

We are passionate about developing our people, through career development and progression;
Supportive and engaged line management;
Technical and therapeutic area training;
Peer recognition and total rewards program.
Committed to building an inclusive culture – where you can authentically be yourself.

Clinical Support Specialist II

Key skills