Study Start-Up Manager

General Description:

• Clinical Operations leadership role with project responsibilities and accountability in the delivery of Study Start-Up (SSU), initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, SOPs, and local regulations

• Ensures SSU clinical trial activities are executed to expected and specified timelines and quality standards

• Monitors start-up metrics and compliance with CTMS business rules and global eTMF standards

• Responsible for managing and addressing SSU performance

• Actively drives best practices and process improvement to optimize efficiencies in delivery

• Leads team in achievement of study, departmental, and organizational goals by providing guidance, support, and development opportunities

Essential Functions of the Job:

• Demonstrates mastery of skills required to conduct SSU activities from selection through activation

• Manage SSU resource allocations and conduct ongoing assessments to ensure balanced workload for quality delivery

• Provide country-specific SSU expertise to project teams

• Assignment as SSU Lead, providing back-up support as needed for direct reports' studies.

• Competent in communication and influencing skills to ensure timely follow-up, risk mitigation, issue resolution, and updates to teams

• Manage and maintain local SSU tools and resources

• Familiar with ICF GCP, relevant country regulations/guidelines, and SOPs

• Facilitate SSU Forum discussions

• Support in resource forecasting activities

• Contribute to the development of local workflows to streamline output and deliverables

Supervisory Responsibilities:

Line Management

• Interview and onboard new hires; ensure ongoing training compliance

• Conduct regular 1:1s to assess workload, provide guidance and feedback, develop team

• Conduct mid-year and year-end performance check-ins and reviews

Computer Skills:

• Proficient in Microsoft Office - Outlook, Word, Excel, PowerPoint, Teams

Other Qualifications:

• Knowledge in the execution of clinical trials, understanding of ICH/GCP

• Effective prioritization in the achievement of goals

• Strong written and verbal communication skills

• Highly organized

• Diligence in follow through

• Two years of management experience

• Line management experience

• Functional Service Provider model knowledge and/or experience

• Mentoring and training team members

Travel: Up to 10%

Education/ Experience Required:

• Bachelor's degree or higher in a scientific or healthcare discipline preferred.

• Minimum of 5 years progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, or CRO environment

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.