Global Study Lead
Company: Disability Solutions
Location: Pleasanton
Posted on: October 6, 2024
Job Description:
Roche fosters diversity, equity and inclusion, representing the
communities we serve. When dealing with healthcare on a global
scale, diversity is an essential ingredient to success. We believe
that inclusion is key to understanding people's varied healthcare
needs. Together, we embrace individuality and share a passion for
exceptional care. Join Roche, where every voice matters.The
PositionA healthier future. It's what drives us to innovate. To
continuously advance science and ensure everyone has access to the
healthcare they need today and for generations to come. Creating a
world where we all have more time with the people we love. That's
what makes us Roche.Clinical Operations is dedicated to delivering
compliant evidence to bring value to patients and customers. We are
organized to improve effectiveness and efficiency in how we deliver
value to patients and customers.The Opportunity:Leads the global
study team with full accountability for the study deliverables with
respect to quality, budget, and timelines, in collaboration with
the Study Team, and ensures the development of high-quality study
designs for sponsored studies in collaboration with internal and
external experts. In collaboration with Program Leadership,
prepares different scenarios for evidence generation (e.g.,
studies, real-world evidence) in cross-functional collaboration
(e.g., with Regulatory Affairs, R&D, CDMA Project Teams) to
support global strategies and the planning of timeline and costs.
Develops key study documents, including the Design Validation Plan,
protocol, study training materials, study forms and templates, and
study report. Oversees planning and operational aspects of
companion diagnostics studies sponsored by Pharma partners.
Additionally, the role is accountable for the study-level budget of
assigned studies.
- Adherence to regulations, guidelines and standard operating
procedures, and ensures audit/inspection readiness.
- Execution of sponsored studies for assigned areas of focus for
registrational and/or non-registrational purposes through all study
phases (planning, start-up. conduct and close-out). Overseas study
activities outsourced to a service provider (i.e., CRO).
- Ensure that study results are published in collaboration with
the Publication Team.
- Oversees projects to ensure completion on-time, within scope
and budget; and tracks project performance to analyze the
completion of short and long term goals.
- Build and maintain strong, collaborative relationships with
cross-functional leaders, key internal and external stakeholders
and other alliance partners, including CROs, in meeting business
goals and ensuring operational excellence.
- Build and maintain relationships with international opinion
leaders, investigators and key customers, bringing external
know-how in-house for the development of new products and
innovative study designs.This is a remote based role.Who You Are:
- You are established in career with at least 5 years of
experience.
- You hold a Bachelor's degree in Life Science and/or relevant
expertise in the Healthcare Industry or a related field.
- You have clinical trial management knowledge and experience in
the oversight and conduct of clinical trials within the core
laboratory or serology diagnostics indication areas
- You have a conceptual and practical knowledge of Product
Development and basic knowledge of Clinical Operations or related
areas.Preferred Qualifications:
- You have experience or background in multiple disease areas is
a plus.
- You have clinical trial management knowledge and experience in
the oversight and conduct of clinical trials within the
Personalized Healthcare Solutions (PHCS)/Companion Diagnostic
studies (in partnership with a Pharma partner) area.
- You have clinical trial management knowledge and experience in
the oversight and conduct of clinical trials within the
pathology/tissue diagnostics indication areas.
- Knowledge of best approaches and the role of Clinical
Operations in product development; is aware of Roche's place in the
market and our value proposition to patients and customers.
- Able to serve as a resource for colleagues with less experience
and provides functional guidance; can lead moderate sized projects
with manageable risks and resource requirements.
- Solves complex problems; takes a new perspective on existing
solutions; exercises judgment based on the analysis of multiple
sources of information
- Explains difficult or sensitive information; works to build
consensusRelocation benefits are not available for this job
posting.The expected salary range for this position based on the
primary location of Pleasanton, CA is $94,600 and $207,400 annually
of hiring range. Actual pay will be determined based on experience,
qualifications, geographic location, and other job-related factors
permitted by law. A discretionary annual bonus may be available
based on individual and Company performance. This position also
qualifies for the benefits detailed at the link provided below.Who
we areAt Roche, more than 100,000 people across 100 countries are
pushing back the frontiers of healthcare. Working together, we've
become one of the world's leading research-focused healthcare
groups. Our success is built on innovation, curiosity and
diversity.Roche is an equal opportunity employer and strictly
prohibits unlawful discrimination based upon an individual's race,
color, religion, gender, sexual orientation, gender
identity/expression, national origin/ancestry, age, mental/physical
disability, medical condition, marital status, veteran status, or
any other characteristic protected by law.If you have a disability
and need an accommodation in relation to the online application
process, please contact us by completing this form .
Keywords: Disability Solutions, Pittsburg , Global Study Lead, Accounting, Auditing , Pleasanton, California
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