Manager, Operations - Data Monitoring & Endpoint Adjudication Committees (DMC/EAC)

Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Connecting the clinical research ecosystem, Advarra delivers solutions through a site-centric approach that unifies and accelerates the drug development lifecycle, making clinical trials safer, smarter, and faster.

General Summary

Advarra is a clinical research compliance company. Biostatistical Services focuses on oversight of research through Data Monitoring Committees (DMC) and Endpoint Adjudication Committees (EAC). The DMC/EAC Operations Manager provides leadership level support to the biostatistical services team, manages the overall process of planning, scheduling and controlling DMC/EAC projects from initiation through to project closeout. The position is responsible for ensuring the operations team's timely completion of DMC/EAC administration tasks including creating, monitoring and closing out integrated project timelines, assisting in the optimization of resource allocation and processes involving intra- and inter-organizational and cross-functional teams focused on the development, conduct and delivery of clinical research and post-market process. The Manager works with team members and collaboratively with inter-departmental stakeholders to establish and maintain operational success as defined by Advarra's Corporate Leadership Team.

This position is available remotely.

Principal Duties & Responsibilities

Operations Management

• Provides management and operational oversight to the team of DMC/EAC coordinators and monitor the overall performance of the DMC/EAC projects from initiation through delivery, interfacing with the team while organizing interdepartmental activities ensuring the completion of the project/program on schedule and within budget constraints.
• Meet regularly with team members basis to ensure that project/program milestones are met.
• Coordinates activities of staff to ensure that project components are implemented according to SOP's, project charters, and timelines.
• Coordinate with project accounting and consulting teams to unsure DMC/EAC projects are set-up appropriately for billing and project accounting activities as appropriate.
• Ensures that information regarding new organizational initiatives, programs and policies is disseminated, and that initiatives are implemented as planned.
• Build relationships with clients and keep clients abreast of current status through frequent project status updates.
• Maintain lists of potential members in the talent database and interact with DMC/EAC committee members to support their on-boarding, contracting, and retention.

Leadership

• Identifies opportunities and strategizes solutions to improve operational accuracy, consistency and efficiency.
• Train, develop, and evaluate staff
• Identify, communicate and address management performance issues on a timely basis, and escalate all others.
• Provide leadership and direction through operational and organizational change.
• Maintain accessibility and availability for staff to escalate questions or complaints.
• Perform regular and annual performance reviews of staff.
• Support management in the engagement of staff to foster team morale.
• Represents Biostatistical Services in audits.

Training

• Ensure staff training and professional development strategies are sufficient and successful.
• Provide on-the-job training and professional development to management and staff where appropriate.
• Monitor and develop process improvements to established systems.
• Identify opportunities to improve people, process, and policy and collaborate with management to evaluate and prioritize those opportunities.

Additional projects

• Additional project support and execution as directed by Executive Director, Biostatistical Services.
• Assign and oversee projects delegated to select areas of management and staff.
• Other duties as assigned

Job Requirements

Education

• Bachelor's Degree

Experience

• 3+ years experience in a regulated industry - preferably in clinical research
• 3+ years successful supervisory experience
• 2+ years of specific DMC, EAC or similar research oversight committee administration preferred

Knowledge/Skill/Abilities

• Advanced knowledge of federal and international regulations and guidelines pertaining to Data Monitoring Committees, Endpoint Adjudication Committees and general clinical research
• Knowledge of Good Clinical Practice guidelines
• Working knowledge of protocol design and clinical trial conduct
• Developing and motivating teams
• Supervisory and management of entry level team members as well as exempt level professionals
• Excellent written communication skills and interpersonal skills
• Demonstrated experience using sound judgment concerning business decisions and sensitive client and/or employee issues
• Creative, strategic, and critical thinking problem-solver
• Strong computer skills with demonstrated proficiency in MS Office tools
• Cultivate and manage business relationships
• Edit technical and/or medical documents using current software/platforms
• Convert technical/medical information to lay terms
• Read and comprehend advanced technical/medical documents
• Compose business text such as letters, memos, e-mails and reports; edit, revise, correct, proofread
• Highly organized and efficient; process and procedure oriented
• Able to provide focused and accurate work with a high attention to detail under time constraints
• Able to manage conflicting demands and priorities

Physical and Mental Requirements:

• Sit or stand for extended periods of time at stationary work station
• The employee must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus
• This position requires regular oral/written interaction with clients, team members and management in English
• Periodic traveling may be required within the United States, infrequent international travel

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EEO Statement

Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated. EEO/M/F/Disabled/Vets

Advarra employees must be fully vaccinated against COVID-19 as a condition of employment unless a medical or religious exemption is approved. Being fully vaccinated means that an individual is at least two weeks past their final dose of an authorized COVID-19 vaccine regimen. This offer of employment is contingent on meeting these requirements and may be rescinded after 10 days if employee is not compliant or has not entered into the process to become compliant or request exemption. Employees must be either fully vaccinated or have received an approved exemption as of their first day of work. Requests for exemption should be coordinated through your recruiter.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)