NAMSA

Manager, Clinical Operations

NAMSA

full-time

Posted on:

Location Type: Remote

Location: United States

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About the role

  • Assists in planning, and coordinating both global and regional clinical, biostatistics and data management operational activities of the Clinical Department as applicable.
  • Manages select Clinical Associates within the Clinical Department.
  • Allocates workload for all clinical, biostatistics and data management projects; May take on all the duties and responsibilities of one or more of the functions of the direct reports and/or lead projects, as needed
  • Confirms appropriate regulations and procedures are applied and followed for relevant operational services. Works with regional Director and global leaders to balance alignment with local requirements and global approach.
  • Works with staff to ensure client expectations are met including schedule, cost and quality of services.
  • Assists direct reports in developing effective strategies for communicating with and motivating project team members.
  • Intervenes and problem-solves with challenging clients as necessary.
  • Provides opportunities and coaching to promote education and further direct reports’ understanding of the clinical development process including client business strategy, local regulatory and marketing requirements, and challenging financial, technical, client service and timeline issues.
  • In conjunction with the global team, proposes and implements systems to support internal improvement and NAMSA’s long-term growth.
  • Maintains qualified staff by recruiting, selecting, orienting, and training Associates, and developing personal growth opportunities via training plans, quality oversight/assurance and/or career path planning.
  • In support of the clinical department financial goals, may assist with budget forecasting requirements/capacity; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions.
  • Participates in meetings with prospective clients.
  • May present on clinical topics at regional and local conferences, seminars and NAMSA events, as needed, and supports team member involvement in these activities.
  • Provides scope of project and relevant information to support the creation of proposals. Identifies opportunities to bring in new projects/clients.
  • Offers opportunities to clients for expansion of services to be provided by NAMSA.

Requirements

  • Bachelor’s degree or equivalent experience in a related field, with a minimum of 5 years of relevant experience.
  • Fluency in English and local language, if different, required.
  • Knowledge of Good Clinical Practices and other regulations which apply to clinical trials at various stages of development (feasibility, pivotal, post-market)
  • Familiarity with Medical Device product development process.
  • Familiarity with the role of study management, data management and biostatistics in the clinical trial process.
  • Familiarity with the type and quality of data needed from a clinical trial and how it should be presented
  • Learn and familiarize with all aspects of the clinical trial process including, but not limited to protocol development, site selection/ qualification, site initiation, monitoring, close-out, investigator meetings, DSMB/CEC, central lab management, and site compliance escalation.
  • Familiarity with the global regulatory landscape for clinical research
  • Ability to effectively communicate with and positively influence clients
  • Ability to participate in and present during regulatory inspections of NAMSA
  • Ability to provide work direction, to include organizing, prioritizing, negotiating, communicating relevant project information and scheduling work assignments.
  • Ability to handle multiple priorities and issues, foster a cooperative work environment with high quality standards, and facilitate and manage effective meetings.
  • Expertise in Microsoft Office suite of products (e.g. Excel, Word, PowerPoint, etc.)
  • Ability to travel up to 20%; some international travel may be required
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Good Clinical Practicesclinical trial processprotocol developmentsite selectiondata managementbiostatisticsbudget forecastingclinical development processmedical device product developmentregulatory inspections
Soft Skills
effective communicationclient influencework directionorganizingprioritizingnegotiatingfostering cooperationmanaging meetingsproblem-solvingcoaching