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Senior Clinical Affairs Specialist

Company: HP Inc
Location: Palo Alto
Posted on: June 10, 2021

Job Description:

Position Overview

This position will be in Vancouver, WA, Corvallis, OR, Bay Area, CA, Germany or Remote

You will be a part HP's new exciting IVD business and manage global clinical initiatives and help to develop the clinical strategy, processes, and infrastructure required to support a new business. You will be working with cross-functional teams to bring new products to the international market.

The Senior Clinical Affairs Specialist is a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing clinical strategies and managing complex issues that may have significant impact on the business. This critical role advises projects and/or product development teams on clinical strategy and helps to ensure compliance with Good Clinical Practice (GCP). The Senior Clinical Affairs Specialist will design, implement; and monitors clinical studies for new and modified in vitro diagnostic products. The successful candidate will ensure that the clinical studies are designed to validate the products' intended use and meet regulatory requirements. The position will also provide oversight of CROs and other third-party vendors. This individual is responsible for providing technical expertise and teaching and coaching others on IVD regulatory requirements.

Responsibilities

  • Prepare and/or approve design validation plans; clinical protocols; clinical brochures; case report forms; sample consent forms; statistical plans; and other required documents for clinical studies.
  • Work to identify and qualify clinical investigators and clinical sites; proposes and negotiates budgets for clinical studies; initiates and track payments to sites and manage expenses within study budget.
  • Manage or coordinate all aspects of the clinical monitoring process in compliance with GCP guidelines and regulations including review of all required essential documents necessary for study initiation and ensure audit ready study files throughout the duration of the study.
  • Conduct site visits to provide training for investigator and staff; determine protocol and regulatory compliance and prepare required documentation ensuring data reported is accurate; complete and verifiable, as required
  • Maintain and document professional communication with the clinical sites;
  • Conduct data reviews; prepare data summaries; create the clinical sections of regulatory submissions; strategize and/or coordinate responses to regulatory agencies' questions regarding the clinical study.
  • Identify unsatisfactory results early and take immediate action to resolve issues in a proactive manner
  • Lead the business in development of processes/procedures for and implementation of clinical requirements.
  • Collaborate with and ensure business teams consider the impact of current or emerging clinical issues; facilitate and ensure company practices are consistent with the corporate risk posture.
  • Review and approve documentation for compliance with US, EU, and other international regulations
  • Evaluate and approve proposed changes to products and controlled documents; develops, approves, and implements action plans based on the changes.
  • Review and approve labeling (Instructions for Use, labels, promotional materials) for compliance to standards, guidelines, regulations, and regulatory approvals/clearances.
  • Prepare and deliver training programs to the department and other functional groups to ensure compliance.
  • Monitor changes in the regulatory environment, evaluates impact, and communicates to interested parties.
  • Identify and manage areas of potential noncompliance
  • Participate in the internal audit program and support external audits or inspections
  • Other activities as required by the business

Required Knowledge/Skills, Education, and Experience

  • Bachelor's Degree, Master's Degree, or Ph.D in Engineering, Science or equivalent
  • Typically 10+ years experience, including graduate or postgraduate research, with a minimum of 4 years of experience in an FDA regulated industry required; preferably with IVDs.
  • Prior experience in supporting clinical trials for 510Ks in the US and IVDD/IVDR in the EU
  • First-hand knowledge of applicable US (21 CFR 820) and EU (ISO 13485) quality system requirements; Understands: Design Control, GCP, In-Vitro Diagnostic Regulation, Essential Requirements, labeling requirements, and regulatory requirements of pertinent regions.
  • Highly developed writing and interpersonal skills with the ability to work on diverse teams located at different geographical locations
  • Demonstrated experience developing effective clinical strategies
  • Ability to apply advanced skills to resolve complex problems not covered by existing procedures or practices independently
  • Strong networking and communication skills
  • Good time and project management skills with the ability to multi-task
  • Strong leadership skills

#LI-post

About HP

You're out to reimagine and reinvent what's possible-in your career as well as the world around you.

So are we. We love taking on tough challenges, disrupting the status quo, and creating what's next. We're in search of talented people who are inspired by big challenges, driven to learn and grow, and dedicated to making a meaningful difference.

HP is a technology company that operates in more than 170 countries around the world united in creating technology that makes life better for everyone, everywhere.

Our history: HP's commitment to diversity, equity and inclusion - it's just who we are.

From the boardroom to factory floor, we create a culture where everyone is respected and where people can be themselves, while being a part of something bigger than themselves. We celebrate the notion that you can belong at HP and bring your authentic self to work each and every day. When you do that, you're more innovative and that helps grow our bottom line. Come to HP and thrive!

Keywords: HP Inc, Palo Alto , Senior Clinical Affairs Specialist, Other , Palo Alto, California

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