Clinical Project Manager

Philips Consumer Lifestyle offers rich, new consumer experiences that meet consumers' desire for wellness and pleasure, starting from our consumer insights and guided by our brand promise of Sense and Simplicity". We are a highly consumer driven organization looking at the individual's interests in terms of their Space, their Mind, their Body, and their Appearance.Philips Consumer Lifestyle is one of three market-driven sectors within Royal Philips Electronics, delivering lifestyle solutions for personal wellbeing. Consumer Lifestyle's headquarter is based in Amsterdam with its highly international workforce of approximately 25,000 employees spread over 50 countries with sales in more than 100 countries. Philips Consumer Lifestyle operates in the business activities TV, Audio and Video, Personal Care, Small Domestic Appliances, Mother & Child Care, Electronic Accessories and Professional & Business Solutions.Examples of our products are the Whole-fruit juicer, Swarovski encrusted headphones, Aurea ambilight television, Wake-up Light, arcitec shaver and the One-touch espresso machine. Clinical and Scientific Affairs Your Responsibilities: The Clinical Project Manager (CPM) coordinates clinical studies with outside partners such as dental professionals or research sites/Universities in support of product development and substantiation of marketing claims. The CPM represents the department on project teams in support of new product development/product life cycle support. ESSENTIAL COMPETENCIES, DUTIES & RESPONSIBILITIES:Define & align the objectives / goals of clinical studies:* Interact with project team to develop marketing claim requirements* Align study objectives and timing with project team, marketing, legal counsel and clinical personnel (VP C&SA, Director Clinical Operations)Select site for clinical studies:* Select site(s) for clinical studies based on study and regulatory requirements Organize & monitor clinical studies, including reporting (final protocol):* Initiate and organize clinical studies supported by external vendors* Negotiate study contract (supported by Director Clinical Operations)* Write study protocol (supported by internal personnel)* Support preparation of the study* Monitor study progress and timelines * Interpret statistical analysis of study outcome with Support Core* Write and/or respectively review, study-related documentsManage and monitor clinical study budget:* Follow and track study expenses versus budget (supported by Director Clinical Operations)* Give input for budgeting for next year's AOP (Annual Operating Plan)Project Lead:* Attend regular meetings with project teams to define and develop the scope of C&SA contribution in creation of new products and support of existing products.* Communicate and organize C&SA activities in support of project teams/product development Your Profile: Clinical Research/Test Methods Competencies:* Communication skills (interact with project leads from R&D & marketing on function development and claim requirements)* Writing skills (study related documents, protocols, reports, etc.)* Regulatory requirements knowledge - US, UK, EU, IRB, ADA, OSHA/WSHA, HIPAA* Basic clinical and statistical study design principles* Oral pathophysiology, microbiology, biomarkers* Quality management and GCP * Screen and select new external vendors/Investigators* Literature search and review* Web-based data collection applications, knowledge of key areas of ComplianceNon Clinical Competencies:* Relationship Management - Build and maintain relationships with dental professionals, research sites, including universities and external vendors, internal stakeholders* Build and maintain relationships with project stakeholders (R&D, Marketing, Operations, etc)* Presentation Skills - Present findings to internal stakeholders, external collaborators* Communication Skills - Act as study monitor and single point of contact and investigator; submit monthly reports to Director. Work cross-functionally within the organization to develop and meet deliverables* Influencing Skills - Work with investigators on ensuring clinical plan is on schedule. Work with project team to align on clinical objectives* Negotiation Skills - Negotiate contracts with sites and investigators, director, Clinical Operations to approve* High-capacity multi-tasking, ability to prioritize and function effectively and quickly on multiple projects* Critical thinking and Interpretive skills - view CSA as an extension of the larger business, work proactively to understand the context of the CSA deliverables, network within and outside the company as appropriateAdministrative Competencies:* Time Management Skills - Ensure reports and studies delivered as per project plan* Basic Management Skills - Capable of handling several projects simultaneously* Writing Skills - Research protocols and study reportsQualities:* Strong Interpersonal Skills - Ability to work with internal and external resources and stakeholders* Detail Oriented - Accuracy in recording and analyzing information* Ability to work 5 days per week, 40 hours Contacts: Philips Notes Philips is an Equal Opportunity Employer Job ID: 49617 Apply here View all "Philips" jobs Learn more about Philips Send this Job to a Friend