Associate Clinical Operations Manager

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 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.

About Us

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.

For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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