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 Monitoring according to Regulations and Enterprise QMS.
Contribute to Philips’ each BU applicable products and input for the CDMA Clinical activities request and excellent balance the time plan, budget, and business priority of the Clinical Studies.
To succeed in this role, you’ll need a customer-first attitude and the following
BS/BA in scientific or relevant discipline. GCP Certification of NMPA and Clinical Study monitoring and management training as priority considering.
Self-motivated individual who can manage multiple tasks and priorities in an efficient manner.
Able to prioritize and address delegated tasks in matrix organization.
Able to work effectively with internal and external clinical research stakeholders who need study support.
Minimum of 3+ years Prior experience providing administrative support in a clinical trial, data management or Institutional Review Board or regulatory setting.
Site assessment/monitoring experience is required.
Able to interpret content of documents to accurately file.
Highly effective organizational capability.
Able to communicate effectively with internal colleagues and external collaborators.
Able to perform document/file audits and report deficiencies to CRAs and Managers.
Clinical Operations Competencies - Apply
In return, we offer you
A path towards your most rewarding career with high level of autonomy. We welcome you to a challenging, innovative environment with great opportunities for you to explore.
How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
