The Manager, Clinical Support Services (CSS) is responsible for the line management for Clinical Trial Assistants and Clinical Records staff. Ensures study teams have adequate resources for administrative and ongoing support for all applicable tasks.  Manages the workflow process for paper and electronic document management and prioritizes work. Assigns resources to accommodate ongoing workflow. Leads quality assurance and process improvement efforts across both TMF and study conduct. Oversees creation and maintenance of the Trial Master File and archival for all study-related paper and electronic documents. Ensures fulfillment of customer requirements and compliance with regulations. Analyzes processes and develops strategies to increase efficiency. Participates in business development as subject matter expert in Clinical Records functions.  

DUTIES AND RESPONSIBILITIES: 

  • Work closely with functional team management to ensure deliverables in accordance with ICH-GCP, relevant Standard Operating Procedures (SOPs) and/or Sponsor-specific requirements.  
  • Supervise, mentor and train staff on proper procedures and processes. Conduct interviews and selection, terminations, professional development, performance appraisals, job description preparation and employee training. Advise Clinical Support Services staff on administrative policies and procedures, technical issues and prioritization.   
  • Facilitate processes, resourcing and communications within and across departments. Assign and coordinate resourcing to accommodate ongoing workflow. Monitor productivity and quality of department functions. Act as liaison and facilitator between customers and senior management for related tasks/issues. 
  • Support financial management of Clinical Support Services tasks on projects, as well as provide strategic development for process improvements.  
  • Create, review, approve and/or present prepared information at project, departmental review and/or customer meetings.  
  • Provide direct oversight to Clinical Support Services staff and provide feedback in 1:1 meetings.  
  • Develop, revise and maintain SOPs and provide training on new and revised SOPs as needed. Develop and implement training programs for appropriate departmental teams.   
  • Oversee development, implementation and maintenance of Clinical Records systems; acting as systems administrator and/or supervise a systems administrator. Develop requirements for modifications to existing systems and reports; provide input on requirements for long-term plans. 
  • Work closely with project team and sponsor to develop TMF Plan and structure, TMF processes and timelines at the beginning of a trial. In addition, prepare any updates to the plans as needed throughout the life of the study.  
  • Oversee initiation and setup of Trial Master File for all projects. Controls access to electronic Trial Master File for all project team members.  
  • Receive, inventory, route and maintain applicable project documents (e.g. clinical documents and clinical files as well as project specific regulatory documents, etc.). 
  • Ensure the security and compliance of all documents related to active and archived projects. Ensure that all project documents are maintained in accordance to relevant SOPs.  
  • Ensures prompt responses to each request received for a project document or project file; ensures timely and appropriate delivery, and timely and accurate re-filing of all project documents and project files. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Trial Master File Room. 
  • Control access and provide oversight to Trial Master File Room according to applicable SOPs. Responsible for maintenance of the physical space in the Trial Master File Room work area, including setting up project file structure and restricting access to project files.   
  • Upon study closure, prepares subject files, prepares inventories, and assists in reconciling files; ships files to client and or off-site storage. 

MINIMUM JOB REQUIREMENTS / QUALIFICATIONS: 

  • Bachelor’s Degree (BA, BS) preferred, or equivalent combination of education, training and experience. 
  • Experience working in pharmaceutical, biotechnology or CRO industry and knowledge of the clinical trials process are required.  
  • Experience working in clinical records or trial master file management required. 
  • Experience in audit preparation and execution preferred  
  • Experience in personnel management required.  

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED: 

  • Good computer skills including MS Word, Excel, PowerPoint, Outlook. 
  • Ability to work individually and as part of a project team, meet deadlines & take instruction from multiple individuals.  
  • Must have excellent verbal and written communication skills, as well as organizational skills.  
  • Good interpersonal and listening skills.  
  • Experience with ICH/GCP documentation and process preferred. 
  • Ability to assess, coordinate, and organize/reorganize workload of 
    multiple projects in accordance with project priorities/assignments and timelines with focus on execution. 

CONDITIONS OF EMPLOYMENT: 

Verification of educational requirements, employment history, professional references, and certifications/training. 

WORKING CONDITIONS AND PHYSICAL EFFORT: 

  • Work is normally performed in a typical interior/office work environment 

MedSource is an equal opportunity employer.  We celebrate diversity and are committed to creating an inclusive environment for all employees. 

 

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