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Manager (Safety Operations Team)

3 months ago

Kuala Lumpur, Kuala Lumpur, Malaysia Novasyte Full time
Essential Functions

  • Contribute and assist in global initiatives e.g. Change Management
  • Subject Matter Expert (SME) Committees
  • SOP Review Committees
  • Retention, Engagement, training, processes etc.
  • Develop and implement plans for measuring and improving employee engagement ensuring global consistency. Maintain open and regular communication with direct reports to ensure a supportive working environment.
  • Contribute to, implement and support operational decisions as determined and instructed by senior management.
  • Manage Safety Operations staff in accordance with organization's policies and applicable regulations.
  • Management of project resource assignments, staff hiring and staff terminations in collaborations with operations specialist managers. Assists with staff training professional and career development.
  • Collaborate with other operations specialist's managers to address problem areas, work scheduling for current and projected projects, staffing needs, equipment needs, and projected peak workloads, ensuring global consistency.
  • Monitor, assess and report utilization of staff. Identify and implement solutions for poor utilization of staff, ensuring global consistency.
  • Ensure direct reports are cross trained on Safety service offering
  • Lead and encourage direct reports in continuous improvement of department work processes, procedures and infrastructure. Instruct and lead direct reports in efficient management of project budgets through effective timesheet reporting. Work closely with operations specialist managers.
  • Monitor and ensure that project processes and department deliverables meet expected quality, financial and productivity targets. Assist with meeting department utilization and realization targets.
  • Ensure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, work instructions and client expectations.
  • Ensure that staff have been trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Work Instructions and project instructions.
  • Work with Safety Management constructively in a matrix framework to achieve project and customer deliverables.
  • Ability to track and monitor project financials and budget.
  • Ability to independently engage customers on escalation and scope expansion.
  • Responsible for ensuring 100% compliance towards people practice and processes.

Qualifications:

  • Bachelor's degree in life sciences or related field and up to 7 years of relevant experience, inclusive of up to 4 years of PV experience and up to 3 years of Line management experience.
  • Indepth knowledge of Safety service lines.
  • Willingness to increase knowledge across Safety service lines and develop new skills.
  • Proven Staff management skills, strong leadership, motivational and influencing skills.
  • Ability to work on multiple projects and manage competing priorities.
  • Effective mentoring and developed coaching skills.
  • Excellent presentation, report writing skills and customer focus skills.
  • Ability to achieve results through communication and facilitation in a matrix service delivery environment with shared accountabilities.
  • Sound judgment, decisionmaking and problem solving skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Understanding on basic Project Finance.
  • May require occasional travel.
  • Flexibility to operate in shifts.


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