Accountable for achieving the final start-up and clinical deliverables (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer
Interprets data on complex issues and makes good business decisions with support from line management
Works to ensure that all start-up and clinical deliverables meet the customer's time/quality/cost expectations
Maintains profitability by ensuring start-up and clinical activity is conducted within contract scope, through efficient management of the country start-up and clinical team
Typically works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities
Manages all clinical and start-up activities, operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP
Ensures timely regulatory submissions (if appropriate) are addressed
Provides input into preparation of forecast estimates for start-up and clinical activities

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
Knowledge, Skills and Abilities: Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
Strong interpersonal and problem-solving skills to enable working in a multicultural matrix organization
Solid understanding of change management principles
Comprehensive understanding of the practices, processes, and requirements of start-up and clinical monitoring
Strong judgment, decision making, escalation, and risk management skills
Effective oral and written communication skills, including English language proficiency
Capable of evaluating own and team members workload against project budget and adjust resources accordingly
Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
Strong attention to detail
In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Capable of independently managing clinical only studies.

Senior/Principal Clinical Team Manager – Internal Medicine

Key skills