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Site Operations Manager- Contractor

Science 37 · Remote · Remote

Posted by Science 37 on their careers site · View the original posting

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Open 57 days

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POSITION OVERVIEW

The Site Operations Manager I is a member of the Clinical Operations department accountable for on-time and on-budget delivery of clinical studies using the highest quality standards.

The Site Operations Manager I will have a broad therapeutic knowledge leading the multifunctional study management team within a matrix environment. The study management team is collectively responsible for planning, solutioning, recruiting, executing, and close-out of clinical studies, within the scope of the client agreement. In doing so, the Site Operations Manager I will oversee all operational aspects of clinical trials according to and in compliance with corporate and project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines and other applicable federal (FDA) and state regulations, to achieve established goals within timelines and budget.

The Site Operations Manager I is the single point of contact to client study teams working with internal and external stakeholders. This individual is accountable for the delivery of the project objectives on-time and on-budget and is responsible for end-to-end execution of clinical trials to ensure effective and timely internal and external communication of study progress, issues, and plans for resolution. The Site Operations Manager I is also responsible for efficient resourcing and financial management of studies under their supervision.

DUTIES AND RESPONSIBILITIES

Duties include but are not limited to

Project Guidelines and Communication

  • Develops a project management plan in conjunction with the appropriate cross-functional teams, outlining planning, execution, and closeout milestones in addition to communication and contingency plans
  • Leads multi-disciplinary Study Management Team
  • End-to-end management of clinical studies to ensure appropriate resourcing and timely and high-quality delivery by all functional areas. Ability to identify and organize resources and services needed to accomplish tasks, sets objectives, plans for contingencies, and manages time effectively.
  • Develops and monitors study metrics to continuously assess study progress
  • Acts as the primary point of contact between Science 37 and sponsor project team, and independently leads internal and external project team meetings

Project Analysis and Management

  • Identifies critical project success factors for tracking, analysis and reporting including impact and probability of project risks
  • Monitors and tracks study status, timelines, and budget expenditures; identifies opportunities and recommends implementation plan for efficiency measures
  • Ensures timely data entry, query resolution and prompt resolution of data issues
  • Coordinates assignment of needed resources for study conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget
  • Identifies out-of-scope work and re

[…]
a best-fit approach. Has a good understanding of other company functions and their inter-relationship to achieve project deliverables.

  • Strong motivational and influence skills – Ability to motivate, influence and guide team members; gains commitments from others
  • Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, study team member and internal Science37 relationships. Ability to conduct effective presentations.
  • Computer skills - Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. Willingness to gain expertise in the use of proprietary software.
  • Financial Skills - Manages and tracks multiple study budgets with a good understanding of study financials
  • Practices professionalism and integrity in all actions - Demonstrates commitment to teamwork, cooperation, self-control, and flexibility in all areas of work.
  • Leadership – Communicates and exhibits leadership behavior consistent with the company-wide keystone focus. Ability to have difficult/crucial conversations.

Capabilities

  • Ability to travel up to 20%, as needed, for project team meetings, client presentations and other professional meetings/conferences
  • Ability to communicate in English (both verbal and written)

Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.

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