CDMA Contract Services Manager
Company: Disability Solutions
Location: Pleasanton
Posted on: October 3, 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
PositionWe advance science so that we all have more time with the
people we love.At Roche Diagnostics, we develop diagnostic tests,
instruments and digital solutions with the power to transform
healthcare for people around the globe.Roche is committed to not
only advancing diagnostic solutions that can support healthcare
professionals in making critical decisions for their patients'
health, but also improving the way these essential tools are
integrated into health systems around the world, at a lower cost,
while still achieving the best possible outcomes.The CDMA Contract
Manager (manager) will have key responsibilities and work cross
functionally with internal and external stakeholders, including
Legal, Procurement and Finance. The manager will build and maintain
strong relationships to meet business goals and ensure operational
excellence.
- You will draft, review, and negotiate clinical trial agreements
(Master Service Agreements, Work Orders, and Clinical Trial
Agreements) and site budgets with US and ex-US institutions.
- You will evaluate changes in study protocols to determine the
impact on clinical trial site budgets; you will develop, negotiate,
and finalize budget amendments; you will focus the majority of your
time related to the conduct of clinical trials.
- You will provide continuing support on executed agreements
(e.g., drafting amendments, extensions, and terminations,
interpreting contractual language in response to issues or
questions that arise); you will adhere to regulations, guidelines,
and standard operating procedures, and ensuring contract
compliance.
- You will work closely and communicate with members of the
Lifecycle Finance teams and other internal stakeholders; provide
timely updates on contract and site budget status', identifying and
escalating any potential critical path items as appropriate.
- You will track, maintain, and update assigned contract
information within the CDMA tracking tools, to ensure completeness
and accuracy.
- You will perform other tasks that may be assigned from time to
time to support the overall CDMA function.This is a remote based
position.There is no relocation support for this position.Who You
Are:(Required)
- You have a Bachelor's degree in Life Sciences, Business
Administration, or a related field; (An advanced degree (e.g.,
Master's or MBA) can be a plus.)
- You have demonstrated experience in clinical contract
management, particularly within the diagnostic industry; you have
demonstrated negotiation and communication skills; you have an
understanding of legal terminology and concepts related to clinical
trials and contract law; you are familiar with compliance
requirements and ethical considerations in clinical research.
- You have a proven track record of negotiating and managing a
high volume (30-40 ongoing contracts) of clinical trial agreements,
vendor contracts, and other relevant legal documents; you have
demonstrated experience reviewing/evaluating contract terms and
identifying potential risks or issues related to clinical studies
in a high-paced research environment.
- You have demonstrated knowledge of all clinical trial
processes, phases, and regulatory requirements (e.g., ICH-GCP
guidelines); you have demonstrated working experience with various
clinical trial stakeholders, including CROs, investigational sites,
and regulatory bodies; you have strong analytical skills to
interpret and ensure compliance with contracts.
- You have demonstrated problem-solving skills with experience in
conflict resolution and the ability to handle complex contract
disputes; additionally, you have the ability to anticipate
potential challenges and develop strategic solutions.Preferred:
- You have excellent organizational skills, including the ability
to efficiently evaluate, prioritize and handle multiple changing
projects and priorities.
- You have strong written and verbal communication skills;
including the ability to communicate with all levels within the
organization; the ability to facilitate clear and concise
interactions with internal and external stakeholders.
- You have experience working collaboratively, fostering
professional and constructive relationships as part of a team;
while also working independently to produce data and meet
challenging timelines and goalsThis is a remote based
position.There is no relocation support for this position.The
expected salary range for this position is $67,550 - $148,070.
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, Pleasanton , CDMA Contract Services Manager, Executive , Pleasanton, California
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