Manager, Clinical Operations

Role Overview

• Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned areas including Site Selection support, site contracts support, regulatory/ethics submissions, site activities including site activation as well as On-Site Monitoring and/or Central Monitoring through Study Close Out.
• Provides training, consultation and oversees metric compliance and quality related to operating activities of assigned staff to ensure project deliverables are met.
• Collaborates and oversees Clinical Operations Team to ensure fulfillment of customer requirements and compliance with related regulations.
• Supports senior management in operational level planning.
• May participate in business development presentations as a subject matter expert in Clinical Operations functions within the Company.
• Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counseling.
• Review workload for all staff in reporting chain, participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced and staffing needs are identified in a timely fashion.
• Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
• Assist in recruiting new staff, including participation in interview process and new hire onboarding.
• Proactively work to ensure staff retention and turnover rates remain within expected levels.
• Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP. Ensure all staff follow required training and complete required documentation. Provide regular updates to management accordingly.
• Work closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, customers, and auditors. Able to contribute to BU level process improvements.
• May conduct several types of sign off and assessment visits to ensure Clinical Operations on-site performance. Develop and oversee training plans to address performance deficiencies. Ensure staff adhere to training guidelines, training records maintenance, and individual and corporate training needs are identified and addressed.
• Organize and chair clinical staff meetings at regular intervals. Manage issues and provide follow up for action items requiring resolution.
• Facilitate and support project and team/country reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis. Use department systems, reports, and dashboards to identify performance issues, process gaps and monitor overall performance progress in line with departmental goals and metric targets. Oversee all quality control efforts of assigned teams.

Requirements

• Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required.
• Preference to have experience in the industry, managing clinical portfolios, and in clinical operations.
• Strong experience in Regulatory & Startup process.
• People management experience in managing 15-16 direct reports.
• Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirements.
• Excellent communication, presentation, interpersonal, and change management skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Strong time management, technical and organizational skills. Ability to work independently and within a team environment.
• Knowledge of basic financial concepts as related to forecasting and budgeting. Understands project budgets.
• Must demonstrate good computer skills and be able to embrace modern technologies.
• Ability to travel as necessary (up to 25%).

Tech Stack

• Google Cloud Platform

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.