Healthcare Project Manager Salary in Florham Park, NJ

The Senior Trial Manager, Clinical Operations is responsible for conduct of global clinical studies.  With minimal oversight, manages CRO and vendor performance to ensure that clinical studies are completed in accordance with contract specifications and management’s expectations. RESPONSIBILITIES  Oversee and manage all operational aspects of phase I – IV global clinical trials in order to achieve a high quality product for the marketplace and business success for Shionogi Inc. Manage external partners, consultants, vendors and budget to ensure the timely and cost-effective implementation of clinical trials. Coordinate the assessment of CROs and preferred vendors for implementation of clinical development plan. Review contracts, work orders and invoices prior to submission to senior management for approval. Establish and maintain effective communication and collaboration with functional area peers including Pharmacovigilance, Drug Supply, Quality Assurance, Regulatory Affairs, Legal, Medical Writing, Biostatistics and Data Management to meet program objectives and support achievement of goals. Responsible for resource requirements (time, financial, manpower) within Clinical Research and management within agreed upon parameters. Responsible for completeness and accuracy of the study synopsis, protocol, case report and informed consent forms, clinical study reports, Annual Reports, and IB. Responsible for leading protocol and study specific clinical and operational meetings. Contribute to and support selection of all study-related vendors. Specific Duties Accountable for working closely with Shionogi Biometrics, Data Management, Pharmacovigilance and the CRO (when appropriate) to complete data management and bio-statistical analysis and oversee adherence to study timelines and data quality. Oversight includes the following areas: query resolution, logic edit checks, data line listing review, QA/QC of adverse events, and serious adverse event processing. Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, and completion of Trial Master File. Responsible for initial RFP obtainment and contributes to CRO/vendor selection Responsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs); as well as oversee scope change negotiations. Responsible for negotiating site CTAs in conjunction with the Legal Department and CRO. Responsible for patient recruitment and retention plans Responsible for the set-up of all third party vendor specifications (ie. IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables. Responsible for collecting, preparing and reviewing regulatory documentation for IRB submission prior to study start-up. Responsible for participating and presenting at Investigator Meetings. Responsible for program level budget forecasting and quarterly review. In conjunction with Drug Supply, responsible for assuring sufficient clinical drug supply is packaged, available and shipped to sites for study start up, and that sufficient supply are maintained during the study. Responsible for assuring accurate drug accountability/reconciliation for IP issued during the study to the site and at the end of the study. In conjunction with CRO responsible for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.). Responsible for preparing and/or presenting executive management slide decks. MINIMUM JOB REQUIREMENTS  BA/BS in life sciences or equivalent; or RN/BSN. Advanced degree or certification preferred At least 6 – 8 years of clinical research experience, with a minimum of 4 years having effectively led a project from inception to completion coupled with demonstrated ability to hold team members accountable with minimal oversight. Demonstrated expertise in daily oversight of CRO relationships and activities and a track record for completing trials on time and within budget. Knowledge of pharmacokinetics and pharmacodynamics with other supportive scientific and/or medical background. Experience and knowledge dealing with Phase 1 studies is an advantage. Significant knowledge of pharmaceutical industry, drug development and regulatory processes in order to maintain compliance with all applicable regulatory guidelines, GCP and Company SOPs and policies. Proficient computer skills and knowledge of standard office software. Ability to travel 10%-15% including possible international travel. PREFERRED SKILLS & EXPERIENCE  Previous experience as a Clinical Research Associate preferred, but not mandatory Strong written and verbal communication skills along with excellent interpersonal skills. Able to make effective presentations across functions and to senior management. Demonstrated ability to resolve multifaceted problems and lead multiple projects of diverse scope, analyze data and exercise sound judgment. High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines. Work comfortably within a fast-paced and dynamic work environment and ability to embrace change. Ability to work cross-culturally and lead by example in establishing a close partnership and maintain flexibility in a cross-cultural environment.  ESSENTIAL PHYSICAL REQUIREMENTS  Ability to articulate clearly and conduct verbal presentations with large and small audiences. Ability to travel via automobile and/or airplane. Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time. Ability to operate a computer keyboard and telephone. Ability to sit for extended periods of time – up to four (4) hours at a time. Ability to lift, tug, pull up to fifteen (15) pounds. To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications. DISCLAIMER The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.  You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits. EEO Shionogi Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.  Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Clinical Development

Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal (GI) diseases. We have licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). Phathom currently markets VOQUEZNA® (vonoprazan) tablets for the treatment of Erosive GERD and associated heartburn in adults, as well as VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. In addition, the company is actively investigating the use of vonoprazan as a treatment for Non-Erosive GERD, with a New Drug Application currently under review by the FDA and a separate Phase 3 trial planned to initiate in 2024.We believe we can change the status quo of treatment for acid-related disorders and have assembled a team of seasoned GI and pharmaceutical industry experts with deep expertise in developing blockbuster therapeutics, including anti-secretory agents. Our team of highly driven professionals are passionate in our mission to address unmet needs for patients and improve their quality of life. Phathom is looking for self-motivated, creative problem solvers who are excited by the idea of working in a fast-paced environment and contributing to our growth.The Senior Product Manager, Consumer/Patient Marketing will be a key member of the brand marketing team driving the development and execution of consumer/patient strategies. This position will help drive the growth of a new branded product.Accountabilities:Support development of strategies and tactical plans to support unmet patient needs and drive brand uptake.Drive development and execution of consumer marketing tactics to generate market differentiation and patient demand.Partner with multiple agencies to produce deliverables on strategy, within timelines, on budget, and measures outcomes across multiple channels.Collaborate with market research and analytics teams to develop research stimuli and manage project plans.Ensure research insights are implemented within tactical execution.Coordinate key performance indicators / metrics to enable performance reporting.Execute rep-delivered educational materials to support initiation of new patient starts.Manager development of multiple marketing assets through the LMR process.Day to Day contact for key tactical projects including creative brief approvals, launch timeline management, and financial management.Coordinate and collaborate with cross-functional teams.Coordinate budget tracking to enable accurate financial reportingEducation & Experience:Bachelor's Degree in marketing, communications, or related field requiredA minimum of 5+ years in product marketing or advertising focused preferably on consumers or patients in the biotech / pharmaceutical industry.Demonstrated understanding of consumer/patient marketing best practices, promotional strategy, and commercial policies and practices required.Proven track record of delivering successful execution across multiple promotional channels including digital media, SEM/SEO, patient support materials, point-of-care, social media, and others.Experience with earned media and social influencer campaigns strongly preferred.Previous experience in marketing, market research and/or advertising/communications agency experience recommended.Strong understanding of project management and budget trackingDemonstrated ability to work in a fast-paced environment, managing multiple projects, and working with minimal shared services.High learning agility and ability to lead projects strategically and purposefully through ambiguity and change.

The CompanyIncedo Inc. is a New Jersey headquartered, data, analytics, design and technology solutions firm with offices all around the globe. We work across Wealth Management, Banking, Life Science, and Hi-Tech sectors. We are a global digital transformation expert empowering companies to realize sustainable business impact from their digital investments. We focus on select emerging technologies and build domain-specific solutions which will make the biggest difference to our clients' business.Description:As a Design Trainee, you'll work with a cross-functional, highly capable team of UX Designers, researchers, product managers, and engineers, inventing and iterating end-to-end product experiences. We are looking for designers who are passionate yet capable to analyze customer behaviors and identify opportunities while being able to articulate human-centered approaches in a fast-paced environment. We're a young and passionate team committed to creating a convenient, delightful and intelligent user experience. Job Description:You will be working with our US design team, involved in the end-to-end design process for various products (mobile and web) to serve the global market audience.You will have experience in defining and communicating design guidelines to maintain competitiveness.You will influence and work to bring teams together to drive towards a singular goal of making a product design successful.You will have a chance to collaborate with cross-functional teams to define, design and deliver forward-looking solutions.You will have a chance to experience cross-platform designs (Web/App) and develop your ideas with user research, prototypes, wireframes, storyboards and evaluate your success through usability testing.Collaborate with internal and external stakeholders to test ideas and to quickly iterate on products/featuresWhat you'll getProject experience and a portfolio case study reviewed by our hiring managers to leave with.Domain expertise in either Financial Services, Telecom, or HealthcareExperience working with global teams in India and North AmericaMentorship in a team with a rock-solid Design Process Requirements:Bachelor's/Master's degree in Human-Computer Interaction, UX Design, Interaction Design, or another program with outstanding fundamental design skills and genuine interest to venture into a career in digital design. OR a UX/UI Bootcamp program0-3 years of experience designing mobile sites, web applications, SaaS platforms, or enterprise software (internships count)Good understanding of the design philosophy and practical experience in user experience design and related fields.General understanding of research methodologies.Ability to move, adapt to change, and iterate quickly. Capable of working in collaborative teams to define use cases, and requirements and deliver the best experience for millions of customers.Experience with Figma is a must.Please provide your portfolio in addition to your resume. It can be an attached soft copy or a URL. Profiles without a portfolio included will not be considered.