Senior/Principal Clinical Team Manager – Internal Medicine

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

📋 Description

• Responsible for meeting the final start-up and clinical deliverables (typically clean data from evaluable patients as outlined in the study protocol) within the timeframe stipulated in the contract with the client.

• Analyzes data on intricate issues and makes sound business decisions with guidance from line management.

• Works to ensure that all start-up and clinical deliverables fulfill the client's expectations regarding time, quality, and cost.

• Maintains profitability by ensuring that start-up and clinical activities are performed within the contract scope, through effective management of the country start-up and clinical team.

• Generally operates independently on projects of moderate to high complexity and may take on regional lead or Clinical Study Manager roles.

• Oversees all clinical and start-up activities, including operational and quality aspects of assigned studies, of moderate to high complexity, in accordance with ICH GCP guidelines.

• Ensures timely regulatory submissions (if applicable) are appropriately addressed.

• Contributes to the preparation of forecast estimates for start-up and clinical activities.

⛳️ Requirements

• Bachelor's degree or an equivalent and relevant formal academic/vocational qualification.

• Prior experience that provides the knowledge, skills, and abilities necessary to perform the job (approximately 5+ years).

• Knowledge, Skills, and Abilities: Strong leadership capabilities, effective in mentoring and training, and able to motivate and integrate teams.

• Excellent planning and organizational skills to facilitate effective prioritization of workloads for oneself and team members.

• Strong interpersonal and problem-solving skills to collaborate in a multicultural matrix organization.

• Solid understanding of change management principles.

• Comprehensive grasp of the practices, processes, and requirements of start-up and clinical monitoring.

• Strong judgment, decision-making, escalation, and risk management abilities.

• Effective oral and written communication skills, including proficiency in the English language.

• Ability to assess personal and team workloads against project budgets and adjust resources accordingly.

• Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management.

• Exceptional attention to detail.

• In-depth understanding of relevant regulations such as ICH/GCP, FDA guidelines, etc.

• Proficient computer skills to effectively utilize automated systems and software applications, including Outlook, Excel, Word, etc.

• Capable of independently managing clinical-only studies.

🏝️ Benefits

• Continued career advancement opportunities.

• Award-winning training.

• Benefits focused on the health and wellbeing of our employees.