Operations Manager

DEPARTMENT: Medical Writing

REPORTS TO: Director

SUMMARY

Accomplishes department objectives by managing staff; planning and evaluating department activities. Oversees deliverable timelines and company commitments to Sponsors for all data and report deliverables. Independently facilitates and oversees the coordination, quality control of study/data, which accurately reflect the study data and fulfill all protocol and regulatory requirements. Manages project coordinators and oversees project coordinator functions, processes, and data QA practices for company.  Provides guidance and sets standards regarding specific study data collection processes and provides assistance/mentoring/training to various departments and their staff to ensure high quality data collection and documentation practices. Assures company deliverables are on-time, provides forecast and dates for deliverables, and communicates scheduling variances from planned dates to Sr. management. Assists in reprioritization of specific study related activities to maximize on-time production in dynamically changing environment.  Works with data analysts, and report writers on assembly, writing, editing, and producing on-time and high-quality reports and protocols. Responsible for inter-departmental communication on department milestones which effect report timelines.  These duties to be accomplished by manager and the assigned staff.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Manage project coordinators and their corporate functions; responsible for overseeing, mentoring staff, scheduling and assigning tasks for direct reports.
  • Manage staff effectiveness by communicating expectations: planning, monitoring, and appraising results; coaching, counseling, and disciplinary actions; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.
  • Produce, maintain, and provide weekly updates of CBSET deliverable tracking tools – present and future. Update company-specific timeline tracking tools as agreed upon by corporate agreements.
  • Maintain accountability in deliverable production processes and notify department management of potential issues before they occur such that department management can assist to alter staffing priorities or duties to meet on-time reporting goals.
  • Advance deliverable tracking tools for the company.
  • Schedule and lead company deliverable meetings to ensure on-time reporting.
  • Coordinate CBSET/Sponsor-driven objectives by developing strategic goals to meet and/or exceed projected departmental timelines.
  • Coordinate and oversee the organization/completion and assembly of raw data, and constituent reporting.
  • Participate in study-specific pre-initiation meetings; suggest courses of action for data collection enhancements or protocol edits.
  • Coordinate and communicate with participating departments, sponsors and outside vendors to help ensure timely delivery.
  • Oversee process improvement projects to enhance departmental efficiency, data collection, or data presentation.
  • Assist in identifying software and hardware needs for department improvement, and other departmental functionality.
  • Perform all other related duties as necessary/assigned.
QUALIFICATIONS:
  • Education: Bachelor’s or Master’s degree in biological sciences. Exceptional experience in a related field could substitute for the education requirement.
  • Experience: Minimum four years experience in a regulatory pre-clinical or clinical testing environment with involvement in medical writer related activities. Exceptional experience in related preclinical/clinical areas could substitute (e.g., study coordination or data coordination).
  • Certification/Licensure: Driver’s license
    • Management Development Program
    • Microsoft Project
  • Other:
    • Knowledge of domestic and foreign regulations as they relate to reporting requirements and to study conduct.
    • Proficiency with Windows-based word processing, spreadsheets and presentation software.
    • Ability to multi-task with good communication, interpersonal, and organizational skills.
    • Ability to adjust priorities in order to adhere to stringent deadlines.
    • Ability to perform under pressure in a fast-paced, multi-task, deadline-oriented environment.
    • Advanced working knowledge of Microsoft Word, Excel, and Adobe Reader.
WORK ENVIRONMENT:
  • General office working conditions, with generally quiet noise conditions.
  • Exposure to laboratory areas with mild noise/odors.
COMMENTS:
  • This position may require occasional domestic travel or performing duties on weekends and/or holidays.

All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

If you are interested in this opportunity please send your CV to jobs@cbset.org.