Clinical Project Manager

Clinical Project Manager

Agensi Pekerjaan EPS Consultants Sdn Bhd
3-6 years
Not Specified

Job Description

Title: Clinical Project Manager
Location: Kulim
  • Facilitates communication between the PMCF teams (internal or external vendor), Business Unit teams and Medical Director to ensure on-time delivery of high-quality regulatory documents for medical devices. These regulatory documents include: Post Market Clinical Follow Up (PMCF) plans and reports, statistical plans and reports and other relevant PMCF documentation.
  • Manages the successful completion of deliverables for regularly scheduled updates of PMCF documentation as well as ad-hoc updates.
  • Develops deliverable project plans/schedules; working closely with the Global Scientific Affairs management, medical writers and BU teams to ensure timelines are met.
  • Schedules deliverable kick-off meetings to confirm deliverable scope, project schedule, assigned SMEs, and availability of source documentation.
  • Responsible to drive the effort in successfully delivering the required documents by the required timelines.
  • Collaborates with cross functional business partners to mitigate risk.
  • Proactively partners with cross functional business partners for example: broader Post Market Surveillance (PMS) team, risk management teams, QA/RA.
  • Implements an effective communication model and tools with cross functional team members that provides deliverable status updates and supports timely completion of deliverables.
  • Anticipates potential deliverable schedule conflicts and challenges for proactive solutions.
  • Ensures escalation of risk management response strategies to Global Scientific Affairs Management
  • Through the implementation of project management and productivity tool, maintain and track progress and produce applicable reports
  • Partner with other project leaders to ensure coordination of activities and timelines, facilitating efficient use of resources to ensure compliant deliverables
  • Partner with Regulatory and Quality Operations as well as IT project management to develop systems and IT tools requirements to support effective standard processes

  • Bachelor of Science/Arts degree in business or a technical, engineering, or science discipline and at least 3 years’ experience in medical device related field. During or additional to those years of experience, direct project management experience is required.
  • PMP certification preferred.
  • Knowledge of Design Controls and experience with FDA and ISO regulations.
  • Requires track record of detailed program management exhibiting comprehensive planning and thorough communication. Experience using MS Project or equivalent tools to schedule and manage development projects.
  • Must be proficient participating in cross-functional teams, as well as coordinating and communicating to multiple stakeholders. Able to manage project prioritization, scheduling, resource utilization, budgeting, and performance validations.
  • Excellent written and oral communication skills.
  • Have a flexible mindset, able to work in a fast-changing environment with competing priorities
  • Strong organizational skills, attention to detail, and business acumen

Job Details

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