Clinical Team Manager, Manager

  • Full-time
  • Department: Clinical Operations

Company Description

Founded in 1997 by a  Medical Doctor, Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for  complex trials in Rare Diseases, Oncology and Neuroscience.

Job Description

The Clinical Team Manager (CTM) Manager supervises the Clinical Team Managers (CTMs) and provides oversight to ensure successful performance and completion of projects at Ergomed. The CTM Manager participates in the interviewing and hiring process, recommends staffing solutions, and manages the performance, training, and growth opportunities of the CTMs.

Duties and Responsibilities:

·         Serve as main point of contact for CTMs for any non-project and project specific needs.

·         Manage performance and support training needs and growth opportunities of CTMs.

·         Communicate regularly with CTMs to ensure their knowledge, understanding, and compliance with assigned project goals and departmental and corporate strategies and objectives.

·         Partner with Project Directors/Project Management to oversee project deliverables.

·         Ensure project priorities are established with the Project Directors/Project Managers and Sponsors.

·         Oversee CTM partnership to ensure effective management of the CRAs as their main point of contact with communication, problem solving and necessary tools.

·         Ensure the CTM is a proactive member of the project team liaising closely with the Project Manager on all clinical monitoring related issues.

·        Ensure monitoring visit reports are being reviewed and approved on time and of quality.

·         Manage effective CTM headcount utilization.

·         Support Business Development by assisting with resource planning for new projects.

·         Participate with the Ergomed Executive Management Team to determine and operationalize corporate strategy and vision for the continued growth of Ergomed.

·         Participate in Clinical Operations-related recruiting, interviewing and hiring.

·         Conduct new employee orientation and onboarding.

·         Work with all operational units to help investigate issues and promote effective resolutions.

·         Assist in the development of quality standards and programs.

·         Provide excellent customer service to both internal and external clients; ensure the same from the CTMs.

·         Review and approve weekly timesheets for Ergomed tasks.

·         Review and approve requests from CTMs for time off.

·         Perform other duties as assigned by Ergomed senior management.

Qualifications

• BA/BS in a Life Science field or commensurate experience.

• Five (5) years of experience in clinical research.

• Prior site monitoring experience.

• Personnel management experience, including performance review, time management prioritization, resource allocation, etc.

• In-depth knowledge and experience of the drug development process including study initiation, clinical monitoring, drug safety, regulatory affairs, data management and analysis, and clinical study report generation.

• Ability to travel approximately 10% both domestically and internationally.  Must possess a valid driver’s license, passport, and maintain a personal credit card or have an available line of credit for charging travel expenses.

• Excellent oral and written communication skills.

• Excellent interpersonal and organizational skills with strong attention to detail.

• Knowledge of the principles, methods, and procedures of clinical research.

• Knowledge of FDA, ICH and GCP guidelines for the conduct of clinical trials in human subjects.

• Ability to motivate and provide technical leadership, advice, guidance, and direction to all levels of staff.

• Exhibit staff development and performance management skills.

• Ability to analyze and interpret data and prepare evaluative summary reports.

Additional Information

We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology.

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