Director, Risk Based Management & Analytics

FHI Clinical

Posted on: May 12, 2022

Closing: July 31, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

Summary of the Position:

The Director, Risk Based Management (RBM) & Analytics has responsibility for bringing together the tools, technologies, applications, and practices used to collect, analyze, execute and present a corporate Risk Based Management approach, processes and systems.

Essential Functions:

  • Serves as chief architect for corporate Risk Based Management (Monitoring) processes and systems.

  • Manages the selection, acquisition, set-up, and validation of systems used by FHI Clinical to deliver RBM services to our sponsors.

  • Provides technical expertise to develop, set up and test study level Risk-based Monitoring system.

  • Assists functional leads in defining key risk indicators (KRIs) for studies.

  • Ensures RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards, and regulatory requirements.

  • Coordinates the integration of data to determine operational trends and impact.

  • Support analytics visualization projects.

  • Works collaboratively with FHI Clinical operational staff and technology service providers to design, build and maintain integrative data and analytics reports from external data, internal data, and other data sources to support reporting and research.

  • Works collaboratively to optimally apply data warehouse, BI architecture, data science and visualization tools and techniques (i.e., dashboards).

  • Identifies and understands business and clinical issues to map these issues into quantitative questions.

  • Assists with the establishment of cross-functional alignment on metrics serving as the “single source of truth” for operational metrics globally.

  • Communicates insights and analytical findings to a broad range of audiences.

  • Represents RBM solutions to customer and project teams and in meetings.

  • Monitors and reports key performance indicators as appropriate.

  • Authors Standard Operating Procedures (SOPs) and Work Practice Instructions.

  • Reviews journals, abstracts, and scientific literature to keep abreast of new developments and to obtain information regarding RBM and emerging methods. Uses this information to broaden or improve our corporate approach or processes related to RBM.

  • Contributes to or develops case studies examining evidence of the impact of RBM at the study and corporate level.

  • Actively participates in industry groups that engage in RBM discussions and the development of white papers, guidelines, or regulations.

  • Manages and ensures maintenance of a positive and productive liaison with internal and external contacts, including regulatory agencies, clients, and related institutions.

  • Leads/attends formal interactions (face-to-face meetings, teleconferences, etc.) with clients.

  • Participates in Kick-off Meetings, Investigator Meetings, and other study-related meetings.

  • Responsible for managing project workflow including prioritizing project objectives and establishing timeframes for projects. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.

  • Manages related project budgets, including out-of-scope activities.

  • Participates in business development activities including proposal and budget development and presents at bid defense meetings by phone or in person.

  • Participates in corporate initiatives as assigned.

  • All other duties as assigned.

Knowledge, Skills and Abilities:

  • Good understanding of the drug development process, laws, regulations, and related guidance, as appropriate.

  • Ability to establish and maintain effective working relationships with coworkers and clients.

  • Expert in planning and delivering work on timekeeping quality in mind.

  • Ability to work on several projects.

  • Ability to follow standard operating procedures consistently; provides independent thought to develop new standard operating procedures or assist in process improvements.

  • Project leadership experience.

  • Make adjustments or recommended enhancements in systems and processes to solve problems or improve the effectiveness of the job area.

  • Ability to adapt quickly to a rapidly changing environment.

  • Established client-facing communication skills – ability to manage situations, negotiate conflicts, and influence others to achieve objectives.

  • Strong follow-up and organizational skills.

  • Expected and empowered to make decisions without direct supervision. Ability to work well independently and within a team.

  • Handle confidential and sensitive matters with discretion.

  • Able to communicate in English, effectively and accurately, both orally and in writing.

Position Requirements:

  • Education: BS or equivalent in life science or related field

  • Preferred Job-related Experience: Minimum of 10 years clinical trial experience for a pharma, biotech, and/ or contract/academic research organization. At least 10 years of experience in clinical operations and project management is required.

  • Professional Skills/Expertise:  Significant experience with regulated systems including but not limited to Electronic Data Capture (EDC/eCRF), Clinical Trial Management Systems (CTMS), financial and resource tracking systems, pharmacovigilance (PVG), Electronic Trial Master File (eTMF),  and Interactive Voice/Web Response (IVR/IWR).

Additional Eligibility Qualifications:

  • Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint), SharePoint, Adobe Professional.

  • Excellent oral and communication skills with technical writing experienced required.

Physical Expectations:

  • Standard office working environment.

  • Ability to sit and stand for extended periods of time; ability to lift 5-30 lbs.

Travel Requirements:

  • The expected travel time is 20% for this position.

  • Willingness to travel internationally and a valid passport required.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.  Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.

FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.

FHI Clinical

Posted on: May 12, 2022

Closing: July 31, 2022

Salary($): Undisclosed

Position Type: Full Time

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