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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

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