Job Title
Associate Clinical Operations Manager
Job Description
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
You are responsible for
· The Clinical Operations Associate Clinical Operations Manager and Clinical Research Associate (CRA) and responsible for management and monitoring of clinical research studies involving human subjects from its inception to close-out according to budget and timelines.
· Ensures that assigned site staff are appropriately trained to the study protocol and to ensure study and data integrity in support of a broader Clinical Evidence Strategy.
· Produces work abiding by applicable Regulatory statutes (such as GCP) and withstanding scrutiny in the event of an audit.
· Actively interfaces with various internal and external stakeholders including Clinical and Medical Affairs Management and functional teams, internal customers, Regulatory, Legal, CRO/vendor staff, and clinical research staff.
· Qualifies, Selects, Trains and Monitors internal and external study Investigators and study documentation.
· Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
· Has extensive knowledge of multiple company products and services.
· Frequently interacts with subordinate supervisors and functional peer groups.
· Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
· May be the lead for site management and expected to communicate well with internal and external business partners including key opinion leaders.
· Works on issues where analysis of situation or data requires review of relevant factors.
· Exercises judgment within defined procedures and policies to determine appropriate action.
· Communicates externally with sites, vendors and internally with project teams, marketing, regulatory and R&D.
· Sensitive to ensuring communication is clear, concise and accurate with guidance from the Manager, Clinical Operations.
· Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.
· Independently monitors and may execute more complex clinical studies with guidance from Leader or Manager
· Strong influence on Business magnitude
· Typically acts as a lead, coordinating the work of Specialist or Coordinator, but is not a supervisor.
· Responsible for creating monitoring reports and follow-up documentation and ensuring completion of updates in CTMS / Medidata and other PIL
You are a part of
Clinical Operations as a team of CMA, our mission is responsible the Clinical Studies Management and M onitoring according to Regulations and Enterprise QMS.
Contribute to Philips’ each BU applicable products and input…