Director, Clinical Operations

The Director of Clinical Operations will provide leadership and guidance for the operations of TRiNDS and oversight of the clinical project management team.
Primary Responsibilities:
  • Build and maintain trial operational infrastructure.
  • Direct the functional organization for execution of all clinical trial programs.
  • Develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines.
  • Develop and direct process for request for proposal (RFP) processes and policies.
  • Represents TRiNDS at cross -functional project teams, and interacts with international key opinion leaders, investigators, and other key customers.
  • Serves as subject matter expert with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
  • Oversee tactical implementation of the clinical project management plan by managing the timeline, resources, budget, and staff of clinical activities.
  • Serves as subject matter expert in quality audits, as well as in regulatory inspections at the investigational site and sponsor levels.
  • Oversee and maintain the relationship with sponsor(s), any vendors, and investigative sites. Typically travels to field sites to supervise and coordinate clinical studies and/or perform as well as oversee site monitoring activities.
  • Write clinical operation sections of regulatory documents including protocols, I nvestigator Brochures, IND annual reports, and others as needed or requested.
  • Maintain a high level of professional expertise through familiarity with clinical literature.
  • Participate on project management team assignments as needed or requested.
  • Closely works with Data Management and Biostatistics on the design of documents and processes for the collection of study data from participating sites.
  • Collaborate with legal department to develop improvements to document templates, standard processes and tools.
  • Supervises the study start-up, monitoring and study close-out activities being performed within the clinical project management team.
  • Ensures that clinical study conduct and record management (e.g. Trial Master Files) for all assigned projects are in adherence to global regulations and guidelines, company quality standards and departmental standard operating procedures (SOPs).
  • Reviews clinical study proposals (regulatory pre-submissions), clinical validation plans, clinical study protocols and reports, publication strategies and manuscripts.
Qualification Requirements:
  • Master’s in Science, Clinical Research Administration or other related field.
  • Minimum of 10 years prior relevant experience in the academic, industry or relevant clinical research organization, with a minimum of 3 years’ staff management experience.
  • Excellent working knowledge of FDA & ICH/GCP regulations and guidelines and experience building clinical operations groups and associated infrastructure.
  • Demonstrated project management/clinical operations experience and leadership skills (e.g. managing cross functional study teams, managing outside collaborators).
  • Knowledge and experience with managing contracts (vendor and site) and interface with finance group.
  • Experience managing an operations staff.

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About TRiNDS (Therapeutic Research in Neuromuscular Disorders Solutions)

TRiNDS is an exciting clinical research contract research organization providing solutions to pharmaceutical and biotechnology industries as well as academic investigators/groups for their neuromuscular clinical study needs. For more information, please visit: www.trinds.com