Senior Clinical Affairs Specialist
Company: HP Inc
Location: Palo Alto
Posted on: June 10, 2021
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.
- 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
- 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
- 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
- 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
- Highly developed writing and interpersonal skills with the
ability to work on diverse teams located at different geographical
- Demonstrated experience developing effective clinical
- 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
- Strong leadership skills
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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