Manager II, Team Lead - 100577 - Fremont, CA - 0300 – Fremont

The Clinical Line Manager will provide regional management to assigned staff members in the Clinical organization. Through collaboration with clinical core team members, ensures clinical programs are carried out to a standard consistent with regulatory, corporate and clinical policies/procedures. Influence the development of policies and procedures across functions. Contributes to and adheres to Clinical department budget. Develops and executes Clinical staffing plan. Facilitates the appropriate resourcing of projects, programs, and staff training and development. Ensures clinical deliverables are of the highest standards. Interfaces with other departments, senior Clinical management, medical directors, senior functional management, and acts as BSC representative with CRO’s.

Duties and Responsibilities:

• Responsible for managing staff based on a combination of the number of people and the type/level of direct reports.
  
• Responsible for training, mentoring, development, and supervision of clinical staff in accordance with BSC policies.
  
• Develops staffing plans for the clinical functions.
  
• Makes hiring decisions and leverages/allocates appropriate resources to support the clinical organization.
  
• Interfaces with Therapeutic Leads / Directors and other management to develop objectives for clinical functions and to gather performance feedback.
  
• Manages interpersonal issues and manages conflict resolutions.
  
• Ensures that best practices of study conduct are leveraged across the clinical organization and implements process efficiencies where possible.
  
• Coordinates global harmonization among staff through other clinical functional line managers.
  
• Responsible for the provision of meaningful metrics to support the clinical organization.
  
• Demonstrates thorough knowledge of and ensures staff adheres to the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BSC SOPs and policies.
  
• Develops and maintains Clinical Sciences infrastructure such as the drafting and/or reviewing of SOPs and Work Instructions.
  
• Contributes to the preparation of and manages to budgets for the clinical function.
  
• Ensures staff is trained on the study specific materials, which include protocols, study tools, etc.
  
  
  
  Minimum Education & Experience:
  Bachelor’s-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. Master level degree (or equivalent), or qualification in clinical trial management preferred. 8+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 3+ years experience managing people and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Previous experience with complex, global trials is preferred. Potential for up to approximately 30% travel to other BSC facilities, research laboratory or hospital settings, and meetings.
  
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