Director, Clinical Monitoring, Functional Service Solutions

Advanced Clinical
Nationwide, United States
Closing date
4 Oct 2020

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Clinical Research, Clinical Trials Manager / Administrator
Full Time
Contract Type
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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 Director of Clinical Monitoring, Functional Service Solutions (FSS) serves as head of clinical monitoring solutions within the FSS department. The Director of Clinical Monitoring FSS effectively manages all aspects of clinical monitoring operations, including meeting all time frames and targets to the sponsor's satisfaction. The role directs the scope of work, objectives, quality of deliverables, and other clinical monitoring activities for functional service programs (FSP engagements). In addition, this position will perform clinical monitoring and site engagement tasks, being hands as needed to satisfy the clients' deliverables. Serve as primary project contact with the client to ensure appropriate communication channels are maintained and reporting schedules adhered to. Ensure the development of project plans for all phases of the project lifecycle. Work with Business Development to finalize the project budget and scope of work and manage project budget(s) to meet financial and company goals, proactively ensuring adherence.

Managerial Responsibilities
  • Understand the Advanced Clinical overall financial plan and our contribution to and support of Advanced Clinical's overall financial goals.
  • Maximize productivity to exceed AC budget goals.
  • Identify possible improvements to current processes, determine new processes that are needed, and initiate a plan to improve or develop said processes.
  • Train, mentor, monitor, and supervise Clinical Research Associates and other appropriate clinical personnel.
  • Work directly with client on FSS projects involving Clinical Monitoring and Site Engagement including performing clinical monitoring and site engagement tasks to ensure quality, compliance, and oversight to applicable regulations.
  • Coordinate teams and assignments of resources across projects to ensure all targets and deadlines are met.
  • Conduct performance evaluations for direct reports according to company policy and procedures
  • Write training and establish training programs for CRAs on new processes.
  • Participate in recruitment and selection of CRAs
  • Create and verify accuracy of billing reports.
  • Deliver Clinical Monitoring Engagements to customer KPIs, KQIs, and SLAs ensuring compliance to all country regulations
  • Creating and using tools to track and report compliance of CRAs to ICH guidelines and GCP.
  • Co-Monitoring of team
  • Standard Operating Procedures (SOPs)
    • Be familiar with and follow department SOPs.
    • Ensure staff is adequately trained on and following SOPs.
    • Create and review Standard Operating Procedures (SOPs) to recognize and prevent potential regulatory issues.

Business Development
  • Assist with RFP/RFI completion
  • Provide strategy and pricing estimates for proposals
  • Attend sales meetings as requested by Business Development

Monitoring Responsibilities
  • Coordinate, attend, and lead client operational visits and teleconferences.
  • Participate in or take responsibility for the review of regulatory documents as and prepare site visit reports.
  • Responsible for multiple projects and must work both independently and in a team environment.
  • Participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
  • Participate in clinical training programs and developmental programs in the field of clinical research.
  • Direct the allocation of resources to clinical monitoring projects by assigning staff to clinical studies that are appropriate to their experience and training.
  • Ensures Monitoring staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
  • Act as a CRA or Manager for a defined project or to assist with milestone achievement.
  • Participate in clinical operations quality or process initiatives.

Perform other duties as requested by management

Work with Business Development in pursuit of their goals

Participate with Marketing and Solutions department toward corporate objectives
  • Bachelor's degree in a health-care or scientific discipline with 10 yrs of industry experience working on clinical trials and 6 years of experience in a senior leadership capacity; or equivalent combination of education, training and experience.
  • Efficient and effective time management skills with ability to successfully manage competing priorities.
  • The ability to establish and maintain effective working relationships with executive management, coworkers, managers and clients.
  • Advanced knowledge of, and ability to, apply GCP/ICH and all applicable regulatory guidelines.
  • Exceptional leadership skills and prove industry vision.
  • Superior written and verbal communication skills including excellent command of English with Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.

Role Competencies:
  • Proficiency of the skills and knowledge relevant to the function. Success in performing most complex assignments with little supervision.
  • Communicates complex issues clearly and credibly with widely varied audiences. Ensures appropriate individuals are informed.
  • Proactively discovers the needs of customers and creates new solutions, services, and processes to meet the customer's changing needs. Works in partnership to improve customer experience.
  • Develops consensus and alignment on ideas and recommendations affecting own team or other teams. Facilitates discussions and gives consideration to a range of interests, opinions, possibilities and situational variables.
  • Creates new and relevant ideas and leads others to implement them. Challenges convention purposefully. Critically assesses established methods.
  • Assesses the effectiveness of systems and current processes; streamlines standards and processes and develops innovative approaches to program development and implementation.
  • Builds and manages strategic relationships to establish mutually beneficial working arrangements, openly sharing knowledge and insights.
  • Demonstrates awareness, flexibility and willingness to adapt approach and/or apply different leadership styles when the situation or individual requires it. Can test assumptions and own stories by seeking ideas and stories of others. Depicts high level of self-discipline.
  • Establishes reputation as a credible and trustworthy source for employees to voice concerns, and share anything that might be negatively impacting their competence and commitment on current goals and tasks. Identifies and responds to underlying attitudes or behavior patterns such as cultural norms and personality differences. Reacts purposefully to frustrations of others. Resolves escalated conflicts among stakeholders through effective dialogue.
  • Accepts constructive feedback and adapts leadership style/actions/behaviors. Creates a sense of well-being by taking an active interest in the opinions and ideas of others, and partnering in efforts to align. Plays to the different strengths and development levels within a team to maximize effectiveness. Helps others through emotional or tense situations, tactfully bringing disagreements into the open, engaging in healthy debate.
  • Facilitates the creation of effective SMART goals by team members, ensuring they tie to wider team and company strategies. Stays knowledgeable on industry trends. Anticipates outcomes of decisions made by the business based on experience and following trends. Monitors financial performance and efficiency of own team.
  • Help and encourage others to identify and leverage transferable skills, and develop the goal or job specific skills necessary for current and future roles. Able to diagnose development level on goals and tasks, and provide the matching leadership style to build competence and commitment, thereby accelerating development.
  • Establish strategies or methods for accomplishing major new directives. Keeps informed on trends in the industry and develops strategies to realize opportunities or mitigate risks.
  • Swiftly administers action if needed and deals with difficult questions head on. Commits to completely new activities that are innovative and feasible or styles of approach that are necessary but feel less comfortable. Measures the risks involved while taking a course of action.
  • Holds self and team accountable to upholding the REAL values. Integrate the REAL values into team processes. Celebrate when witnessing team members exhibiting these values.

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:

Career Development Opportunities:

Community Programs:

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.

Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences.  Visit our website to learn more about how we deliver a Better Clinical Experience:

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