Study Start Up Specialist, Senior

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Lead and oversee the process of study setup, including the formulation of the start-up strategy.

• Coordinate and manage regulatory deliverables to ensure compliance with established targets and procedures.

• Act as the primary contact for project-specific Study Start-Up activities.

• Provide strategic regulatory insights and proactively identify and mitigate risks.

• Prepare, gather, review, and track all regulatory information and essential documents for submissions, site initiation, and site activation.

• Investigate discrepancies, inaccuracies, or missing documentation.

• Generate reports and status updates for the study team.

• Communicate with selected sites regarding document finalization, ICF development, and IRB/IEC submissions and approvals.

• Collaborate with study teams, sponsors, clinical monitoring, contracts, and other departments on documents necessary for investigational product release, site activation, and site initiation.

• Manage or coordinate negotiations for investigative-site contracts.

• Assist in feasibility assessments and site identification efforts.

• Organize or review translations of essential documents.

• Participate in project meetings and training sessions.

• Ensure proper filing of relevant documents within the Trial Master File.

• Monitor departmental deliverables, project budgets, hours, and any out-of-scope work; escalate issues as needed.

• Support, mentor, and train departmental staff and new hires.

• Assist in proposal development, budgeting, and business development meetings.

• Contribute to training and improvements in SOP/practice.

⛳️ Requirements

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.

• A minimum of 5 years of experience in the pharmaceutical/CRO industry.

• Demonstrated ability to successfully manage multi-country projects during the start-up phase.

• Exceptional organizational and management capabilities.

• Strong skills in planning, strategizing, managing, monitoring progress, scheduling, problem-solving, and critiquing.

• Effective interpersonal skills in a dynamic, deadline-driven environment.

• High level of self-motivation and the ability to motivate others.

• Comprehensive knowledge of ICH GCP across all areas.

• Proficient in English, both spoken and written.

• Competence in all MS-Office applications, including Microsoft Word, Excel, and PowerPoint.

🏝️ Benefits

• Full-time employment.

• Collaborative, international team environment.

• Flexible work arrangements.

• Commitment to work-life balance.

• Opportunities for career advancement.

• Supportive team culture.

• Chance to contribute to clinical research and enhance patient care.