Social & Scientific Systems (S-3)

Program Manager

US-MD-Silver Spring
Job ID
2017-1678
Category
Clinical
Type
Regular Full-Time

Overview

Social & Scientific Systems (SSS) 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 of employee-owners in an environment that values diversity and supports health, well-being, and professional growth.

 

 

Responsibilities

  • Lead and coordinate all programmatic activities associated with the development and execution of study protocols and lab work
  • Oversee staff supporting the contract
  • Track the program budget(s) and produce monthly reports
  • Manage project(s) scope of work, work breakdown structures and ensure that timelines, deliverables and client expectations are met as agreed.
  • Develop comprehensive project portfolio plans designed to establish portfolio milestones and communication processes. The Program Manager is expected to work with core team members in the CTC and individuals from other SSS departments to ensure delivery of a quality project(s).
  • Develop study-specific project plans, including project management, communication, safety and escalation plans. The Program Manager will collaborate with the clinical monitoring group on the development of the monitoring plan and required resources to staff the program successfully. The Program Manager will review and approve all project plans for all assigned Identifies areas of risk and opportunities and incorporates risk mitigation plans as necessary within project plans; develops timelines and schedules of deliverables and manages resources to achieve mitigation of the identified risk(s).
  • Responsible for reviewing study protocol, managing internal team’s review and providing feedback to Client in a timely manner.
  • Identify and manage third party vendors as required by SSS / client contract. Oversee vendor deliverables and manage expense authorization process.
  • Oversee and approve the development of study start up documents including informed consent form template, regulatory binder set-up, investigator study manual and arranges for appropriate distribution.
  • Responsible for IRB submissions, recording and tracking all IRB correspondence.
  • Responsible for the oversight and development of investigator recruitment materials including feasibility assessments.
  • Track all study activities and reports on the on-going status of tasks to completion.
  • Develop study-specific project tools including source document worksheets, study diaries, custom trip report templates and other tools as necessary to ensure quality data.
  • Mentor and provide training and orientation to project team members.
  • Plan and participates in investigator meeting per scope of work.
  • Provide project oversight and line management responsibilities to levels I and II Project Managers and other project staff in CRB. Provide performance expectations and feedback for all project team members.
  • Work with multiple stakeholders and meet tight deadlines
  • Help determine the financial and personnel resources needed to achieve contract objectives

Qualifications

 

  • M.S. or Registered Nurse with at least 8 years of experience in clinical sciences
  • Relevant Clinical research experience with at least 3 years in a program manager capacity required.
  • Project Management Certification preferred
  • Prior Experience working with U.S. Army preferred
  • Experience working with the federal government considered a plus

Knowledge, Skills and Abilities:

  • Must have excellent verbal and written communication skills; excellent interpersonal and client management skills
  • Strong working knowledge of GCPs, ICH guidelines, FDA and/or EU guidelines
  • Experience managing multiple Phase I-IV clinical studies
  • Experience with project management tracking systems
  • Solid experience overseeing study budgets and strong negotiating skills
  • Excellent organizational and time management skills
  • Proficiency in all MS-Office applications including Microsoft Word, Excel and PowerPoint, MS Projects a plus.
  • Must possess a professional and customer service oriented demeanor
  • Experience working in matrix environments; ability to work well in a team environment
  • Ability to perform job specific responsibilities with minimal supervision
  • Exercise sound judgment and able to make decisions independently
  • Experience with direct line management, providing feedback and conducting performance reviews
  • Demonstrate problem solving skills, strong sense of urgency and keen attention to detail




SSS 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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