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
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)
Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Publisher)
Ability to manage competing priorities and work in a dynamic fast-paced environment
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
Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
Continuously building the company we all want to work for and our customers want to work with.

Clinical Support Specialist II

Key skills