Sr Clinical Support Specialist

• Responsible for providing operational and administrative support to one or more clinical functions. Responsibilities may include but are not limited to:

• Provide administrative support by coordinating project documentation and communications, including maintaining 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, milestone tracking, and risk projection. Investigate and provide clear rationale for delays, provide support on contingency plan to mitigate risk

• Perform document management activities including document creation, compilation, formatting, version control, and quality control (QC).

• Translation of documents using approved vendors/systems

• Support audits and inspections as requested.

• 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.

• Training and mentoring junior-level Clinical Operations Associates

• 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

Qualifications:

• Bachelors Degree or equivalent combination of education, training and experience.

• 2 to 4 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.