You are a part of Clinical Affairs orgabization. The Clinical Development Scientist reports to the Director of Clinical Affairs in the business.
location: Cambridge, Massachusetts
job type: Contract
salary: $80 - 95 per hour
work hours: 8am to 5pm
education: Masters
responsibilities:
You are responsible for:
- Leading the development of evidence generation strategies for assigned projects, working within a cross-functional team, in line with the value proposition that addresses the evidence needs of all key stakeholders
- Delivery of Clinical Development Plans, describing the plans for clinical evaluation, as per internal and external requirements (US,EU, China, etc)
- Working closely together with internal (project owners, regulatory, clinical study managers, statisticians, business leaders, etc.) and external (clinical consultants such as key opinion leaders and subject matter experts) stakeholders to ensure that studies yield well-founded conclusions.
- Design and development of study protocols in compliance with project standards, specifications and applicable regulatory guidelines (GCP, ICH, FDA, ISO, EU MDR). Manage and oversee study execution, analysis of results and generation of final study reports to support Philips regulatory clearances, claims, epidemiology/surveillance, reimbursement, health economic outcomes and/or market access.
- Deliver assigned clinical programs, working in partnership with Clinical Operations.
- Lead the development and dissemination of evidence generated from clinical evaluation plans to deliver Clinical Evaluation Reports in accordance with EU and China requirements, Clinical Study Reports and Clinical Summaries, and manuscripts
- Lead clinical evidence, epidemiology/surveillance discussions with regulators (deficiency requests/FDA, Notified Bodies, etc.), advisory boards, associations, and societies
- Keeping current with regulatory guidance and requirements in the global environment.
- Ensuring appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, etc.
- Support Medical Safety function to help support signal detection, signal evaluation
- Advance the Philips Data network strategy by developing innovative data partnerships
- Support the creation of data infrastructure efficiency through creation of systematic processes including data dictionaries, including the evaluation of real-world data vendors, and data access and transfer models.
- Support the Data Governance Council in leading understanding of deidentification and data use standards (including, data tokenization)
qualifications:
- Experience level: Director
- Minimum 7 years of experience
- Education: Masters
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
