Senior Clinical Trial Manager

Location US
Job ID
2021-2323
Type
Salaried Full Time Employee

Overview

Social & Scientific Systems (SSS), a division of DLH Corp works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. Please join our dedicated staff in an environment that values diversity and supports health, well-being, and professional growth.

 

FUNCTION: Under general supervision of a Practice Area Director, Director of Clinical Operations, or Senior Project Director, leads and directs multiple small clinical trials, a large fast-paced clinical trial, or multiple clinical trials conducted at a network of clinical research sites.

Responsibilities

  • Develops contract work plan schedules, study milestones, cost estimates and budgets; identifies areas of risk and incorporates risk mitigation plan; using a tracking system, develops timelines and schedules of deliverables and manages resources to achieve
  • Prepares high-quality reports (financial, project, etc.) for senior-level managers on project status.
  • Formulates and implements staffing plans; proposes additional staff and training to meet project needs; coordinates with other company operating units on cross-company staff assignments; works closely with supervisors to conduct performance and salary reviews; addresses performance problems and manages staff conflicts in accordance with company
  • Develops study-specific role-based training plans for regulated clinical trials.
  • Develops metrics to measure clinical research site performance or uses existing metrics to monitor site performance. Develops improvements to metrics or methods of measurement.
  • Serves as primary point of contact and company representative with the client; communicates and negotiates effectively with the client on status/changes to ongoing scope of work, schedules and budget; informs client of contract issues and problems timely and proactively develops solutions.
  • Manage and coordinate all vendors involved in the clinical trials, e.g. central lab, CROs, including managing the RFP processes and overall budget for each.
  • Uses company resources to manage costs within budget; manages expense authorization process, develops and updates cost projections; and provides cost and milestone reports to
  • Develops and oversees implementation of Quality Assurance (QA) plan; manage expectations for quality with client.
  • Identifies new SSS business opportunities with existing clients; communicates opportunities to management.
  • Performs additional duties as required. 

Qualifications

  • Bachelor’s degree in a clinical field or equivalent experience, plus ten years of experience managing federally funded clinical trials in a highly regulated environment.
  • Master’s degree in a clinical field with at least three years of experience managing federally funded clinical trials in a highly regulated environment.
  • Excellent communication, organizational and staff management skills. Experience with project management tracking systems and budgets preferred.

DLH is committed to fostering a diverse workforce and is proud to be an Affirmative Action/Equal Opportunity Employer of Minorities/Women/Protected Veterans/Individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by law.

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