Vice President, Clinical Operations, North America

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Company: AdvancedRPO
Location: Deerfield, IL

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Overview:[

Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.

The Vice President, Clinical Operations, North America provides positive leadership to effectively lead and manage the clinical operations function of the CRO. This is an executive role that requires both strategic and tactical capabilities, excellence in operational processes and innovation in problem solving and business growth initiatives. Responsibilities include overseeing project management, clinical monitoring, document management, and clinical operations quality. The scopes of responsibilities include leadership, policy-making, infrastructure development, personnel development and project feasibility and oversight. Responsibilities also include creating and/or customizing SOPs, hiring of staff, supporting business development activities, and overseeing all clinical projects that include North America. This position will also serve as a credible representation of Advanced Clinical in North America through speaking engagements, networking, and industry publications. This role directs all aspects of Operations including meeting all time frames and targets to the sponsor’s satisfaction. This role is responsible for the execution of the scope of work, objectives, the quality of deliverables, and other Clinical Operations activities, which may be multi-regional or international in scope. This role is responsible to manage and report on the departmental budgets, revenue stream, as well as profit and losses.

This role directs all aspects of Operations including meeting all time frames and targets to the sponsor’s satisfaction. This role is responsible for the execution of the scope of work, objectives, the quality of deliverables, and other clinical Operations activities, which may be multi-regional or international in scope. This role is responsible to manage and report on the departmental budgets, revenue stream, as well as profit and losses.

]Responsibilities:

  • Serves as an executive of the company reporting directly to the SVP, Clinical & Medical Operations or other executive leadership.
  • Lead and develop strategic company initiatives.
  • Understand the AC overall financial plan and contribute to and support of AC’s overall financial goals.
  • Prepare and implement the operational department’s annual budgets and review and approve all respective department staff expense reports and timesheets, as well as invoices payable up to the agreed monetary limit as applicable.
  • P&L oversight of the functional areas within Operations as applicable.
  • Develop strategies and support directors, managers and other staff to drive programs according to agreed timelines; if changes are proposed to agreed clinical milestones and timelines, to assist clinical managers in evaluating the risk of these decisions and developing plans to minimize/mitigate these risks.
  • Accountable customer satisfaction related to operational deliverables.
  • Oversee all aspects of the operational departments including resource planning, deliverables, staff appraisals, performance reviews, and annual salary reviews.
  • Execute strategy for continuing cross-departmental collaboration and company growth, and provide hands-on leadership to create a results-oriented, client focused, team environment.
  • Initiate, lead, and develop strategic business growth initiatives and technology solutions that improve efficiencies.
  • Attend capability and defense presentations with clients to support the development of new business.
  • Attend RFI/RFP proposal strategy meetings and operationally lead strategy development and approve client proposals and budgets.
  • Work closely with Quality and Compliance to ensure quality and continuous process improvement throughout Operational departments.
  • Develop Operations SOPs and ensure staff adherence to company policies, SOPs, federal guidelines and GCPs.
  • Adhere to strict code of confidentiality as it relates to study subjects, sponsors, physicians and policies and procedures.
  • Effectively represent the Operations departments at project review meetings, quality review meetings, and other executive management meetings.

Additional Responsibilities
  • Participate with Marketing and Solutions department toward corporate objectives.
  • Perform other duties as requested by management.

Qualifications:

The ideal candidate should have a degree in a health-care or scientific discipline with fifteen (15) years of industry experience working on clinical trials and ten (10) years of experience in a senior leadership capacity; or equivalent combination of education, training and experience. Candidate must be effective and have efficient time management skills with ability to successfully direct competing priorities. Executive-level operations experience and responsibility in a Clinical Research Organization setting as well as strong leader, manager and team builder skills required. This professional has a proven ability to recruit and retain excellent talent. Have a proven track record of successfully managing multiple director and management-level reports and delivering full-service projects on time, to budget and with the required quality standards. Proven track record of domestic strategic and tactical capabilities, demonstrating both the ability to innovate and execute. Demonstrating experience supporting business development activities P&L and budget experience. Preferred: experience/participation in M&A activities.
Minimum Training Requirements
  • The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:
  • Applicable Standard Operating Procedures
  • Good Clinical Practices (Regulations; Guidances and ICH Guidelines)
  • Advanced Culture, differentiators and operations


What’s in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:


Our Culture: https://careers.advancedgroup.com/embrace-our-culture


Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential

For a complete list of all of our job openings, please visit Advanced Group’s career site here.
It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.