Clinical Study Manager

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  • Vakgebied Engineering
  • Dienstverband Fulltime
  • Vacaturenummer VAC-10017106
  • Locatie Eindhoven
  • Type overeenkomst Secondment via YER
  • Branche High Tech

Over deze vacature

Support the Global Design Community in executing their Clinical Research work to create meaningful and innovative solutions for people, while complying with all clinical study-related procedures in line with PEPF 16.2.16 and 16.2.6 Manage Clinical Studies, EU Medical Device Regulations, Philips Global Privacy Rules and Local Laws like the European GDPR.

To succeed in this role you feel comfortable working in a dynamic, flexible and creative environment that works with speed to deliver on-time and with quality, while procedural aspects are taken care of carefully to ensure correct fieldwork enrollment in healthcare settings and handling of recurrent regulatory and administrative actions. As you are part of a dynamic team of experienced professionals, you are comfortable and capable working independent, taking the lead in stakeholder management of internal and external ethical committees, and proactively managing new ways of working in projects to prevent procedural inconsistencies and incidents.

Functie

Job Title: Clinical Study Manager

In this role, you have the opportunity to

Support the Global Design Community in executing their Clinical Research work to create meaningful and innovative solutions for people, while complying with all clinical study-related procedures in line with PEPF 16.2.16 and 16.2.6 Manage Clinical Studies, EU Medical Device Regulations, Philips Global Privacy Rules and Local Laws like the European GDPR.
To succeed in this role you feel comfortable working in a dynamic, flexible and creative environment that works with speed to deliver on-time and with quality, while procedural aspects are taken care of carefully to ensure correct fieldwork enrollment in healthcare settings and handling of recurrent regulatory and administrative actions. As you are part of a dynamic team of experienced professionals, you are comfortable and capable working independent, taking the lead in stakeholder management of internal and external ethical committees, and proactively managing new ways of working in projects to prevent procedural inconsistencies and incidents.

You are responsible for

Provide leadership in execution and management of clinical studies to deliver high quality data to support Philips businesses on time and in compliance to all applicable regulations and Philips procedures

Support output to Daily Management Board through consistent updates and maintenance of the Clinical Trial Management System, Privacy Kit, and Orion-ICBE

Execute controls according to the PEPF 16.2.6 for clinical studies and clinical investigations

Registration of changes and creation of amendments to re-admit in official procedures, and check of consistency in documentation during the project

Verification that documentation and project execution are aligned

Systematic cleaning and compliance archiving during and at the end of the project initiative.

Ensure communication with team is strong, ensuring feedback is provided in real time through provision of mentoring and leadership coaching.

Ensure projects supported by clinical operations team have been prioritized and resourced.

Ensure global process and procedures for clinical study execution are followed and gaps in understanding addressed through regular training.

Ensure all audit requests, responses, and effectiveness checks are supported, addressed and closed according to jointly agreed timelines.

You are a part of
Philips Design, a global Design organization within Philips. We believe that good design is about creating solutions that satisfy people's needs, empower them and make them happier, all of this without destroying the world in which we live. Our global creative force of some 400 professionals is located in our studios in Europe, North America and Asia.

Our world-class People Research team at Design works across many global locations in multiple business areas for international markets, with one core purpose - to bring meaningful people focused innovation. They bring their skills to bear in defining, conducting, and translating people research for vision, innovation, healthcare consulting and strategic purposes. Through leading research techniques, outcomes are articulated and clear insights and trend directions are derived that increase domain knowledge. By means of outstanding (experience design) translation skills, coordination and multi-stakeholder facilitation skills they support the creation of meaningful and innovative solutions in a future connected world.

To succeed in this role, you should have the following skills and experience
• Bachelor or Masters in Science or Healthcare discipline
• At least 7 years related experience in (conducting) clinical studies (healthcare setting , CRO, medical device and/or pharmaceutical company and/or industry)
• Good command of written and spoken English language
• Excellent verbal and written communications skills
• Several years of clinical monitoring experience including use of eTools such as EDC, ePRO, eConsent, etc.
• Experienced program manager fluent in financials and resource management and metrics reporting up to leadership.
• Excellent interpersonal and organizational skills
• A pro-active, committed and motivated attitude
• A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations
• Ability to work very accurate and thorough
• Excellent record-keeping skills; good documentation practice
• Ability to maintain excellent working relationships with a broad range of clinical study staff.
• Ability to work well in a team environment but also independently without significant oversight
• Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
• Flexibility in work hours and ability to travel as needed.

In return, we offer you
An exciting and unique opportunity to work in a dedicated team of highly engaged and talented team members that are part of the global Design Research community at Design. You will gain opportunities to go beyond your core competencies in an environment that rewards those that take ownership and deliver.

Bedrijf

With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.

Aanbod

Philips Design, a global Design organization within Philips. We believe that good design is about creating solutions that satisfy people's needs, empower them and make them happier, all of this without destroying the world in which we live. Our global creative force of some 400 professionals is located in our studios in Europe, North America and Asia.

Our world-class People Research team at Design works across many global locations in multiple business areas for international markets, with one core purpose - to bring meaningful people focused innovation. They bring their skills to bear in defining, conducting, and translating people research for vision, innovation, healthcare consulting and strategic purposes. Through leading research techniques, outcomes are articulated and clear insights and trend directions are derived that increase domain knowledge. By means of outstanding (experience design) translation skills, coordination and multi-stakeholder facilitation skills they support the creation of meaningful and innovative solutions in a future connected world.

Profiel

Philips Design, a global Design organization within Philips. We believe that good design is about creating solutions that satisfy people's needs, empower them and make them happier, all of this without destroying the world in which we live. Our global creative force of some 400 professionals is located in our studios in Europe, North America and Asia.

  • Bachelor or Masters in Science or Healthcare discipline
  • At least 7 years related experience in (conducting) clinical studies (healthcare setting , CRO, medical device and/or pharmaceutical company and/or industry)
  • Good command of written and spoken English language
  • Excellent verbal and written communications skills
  • Several years of clinical monitoring experience including use of eTools such as EDC, ePRO, eConsent, etc.
  • Experienced program manager fluent in financials and resource management and metrics reporting up to leadership.
  • Excellent interpersonal and organizational skills
  • A pro-active, committed and motivated attitude
  • A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations
  • Ability to work very accurate and thorough
  • Excellent record-keeping skills; good documentation practice
  • Ability to maintain excellent working relationships with a broad range of clinical study staff.
  • Ability to work well in a team environment but also independently without significant oversight
  • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
  • Flexibility in work hours and ability to travel as needed
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