Vice President of Clinical Operations
Company: CARDINAL SERVICES LTD.
Location: Los Angeles
Posted on: January 27, 2023
Job Description:
Research & Development (RDItrials.com) is a research laboratory
and biobank that serves as a Contract Research Organization to the
largest In Vitro Diagnostic companies (Laboratory Medical Device
Manufacturers) in the industry. RDI manages between 20-40 sample
collection and validation studies a year and have supported 120+
assays through the FDA (510K, PMA, and De Novo) and CE regulatory
pathways.
The Senior VP - Clinical Operations will be a member of the
executive management team responsible for building and leading a
high performing team that manages and conducts all of our Clinical
Trial operations. He/she will also be able to solve problems with
improved systems today and then beable to foresee challenges that
may arise from scaling and proactively eliminate them.
He/she is responsible for overseeing both Business Development and
Operations to understand and match our client's needs for
biological samples and or lab equipment with our network of
physicians and labs. He/she will drive the sales process to convert
client's requests into signed clinical trial projects and then
ensure that our operations are conducting high quality, inspection
ready studies that adhere to Good Clinical Practices.
The Senior VP - Clinical Operations is first and foremost a servant
leader to the operations team and devotes his/her attention to our
clients and the conduct of their clinical trials, our physicians
and lab partners. This includes overall responsibility for design
and successful execution of clinical studies under adherence to GCP
and other regulatory requirements. The position will manage a
multisite team that includes senior managers with their teams of
clinical project managers and Clinical Research Associates (CRA) as
well as administrative support staff.
Responsibilities
- Work with our clients in R&D and Clinical Affairs to
understand their sample and instrumenttesting needs and identify
ideal physicians and labs in our network
- Develop executable Statements of Work for clients that clearly
outline all deliverables andpriced to hit company profit
margins
- Source samples and instruments quickly for our clients by
working with the OperationsDirector and Project Manager to conduct
feasibilities with physicians and labs quickly
- Push all projects forward, identify roadblocks and remove them.
You will ruthlesslyprioritize projects and use creative problem
solving that the team may not see to get our projectscompleted
quickly.
- Lead the development, review and implementation of departmental
SOPs and processes.Clinical Trials are a regimented process but
there is ample room to improve and make ourprocesses more
efficient.
- Provide mentorship and career development to direct reports. Be
a servant leader to thegrowing organization.
- Earn and maintain the trust of our clients and physicians. You
will also direct resources toexpand our network of physicians and
labs.
- Staff projects appropriately, understanding when to flex up or
down on staffing needs, in linewith business objectives
- Identify and recruit new 'stars' incrementally - in step with
expected revenue growth
- Site Health: work with site director to assist in expanding our
network of physicians and labsbut also to ensure their interactions
with RDI are high quality and encourage them to continueworking on
our studies in the future
What we look for
- Clinical Trials Experience: experience and knowledge of
clinical lab operations and the assaydevelopment process from
R&D, through clinical trials, and post-marketing
- Diagnostic Industry Experience: 7+ years of management position
in IVD, life sciences ormedical device industry, or CRO; In-depth
understanding of clinical trials, and common IVDproduct development
processes and requirements.
- Systems-first Problem Solving approach: an ability to solve
problems as they occur butdevelop solutions to prevent them from
occurring again.
- Clinical Trial Software Fluency: understands critical software
used to conduct Clinical Trials(eTMF, eCRFs, 21 CFR Part 11
compliant) as implementing technological solutions is critical
toour ability to scale
- Site Health: work with site director to assist in expanding our
network of physicians and labs
- Entrepreneurial leader mindset: high IQ and EQ, takes pride in
being an excellent problem-solver. Leader who is excited to do the
hard work to establish (and sometimes re-establish) the foundation
of a growing business and support the team along the way
- Financial and Contract Acumen: an executive with an MBA or
similar background to be able toprice projects, negotiate
site/vendor contracts
- Hustle: Comfortable in a fast-paced small company environment
and able to adjust workloadbased upon changing priorities
- Diplomat: broker agreement across the company and with partners
or stakeholders; is arespected member of the team; strong
motivator; approachable; entrepreneurial, while hittingthe
numbers
- Track Record of Success: has beaten success metrics 90% of the
time throughout his/hercareer; performance reviews are in top
echelon; promotions were earned faster than most
Keywords: CARDINAL SERVICES LTD., Los Angeles , Vice President of Clinical Operations, Executive , Los Angeles, California
Didn't find what you're looking for? Search again!
Loading more jobs...