Worldwide Clinical Trials

Manager, Data Safety and Monitoring Board (US and ROW)

Location
US or ROW
Salary
Competitive
Posted
09 Jul 2019
Closes
08 Aug 2019
Ref
VN2214
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

We are seeking a Manager, Data Safety and Monitoring Board (DSMB) to join our growing team. This is a full time, permanent role and can be based anywhere in the US or Internationally. 

The Manager, Data Safety & Monitoring Board (DSMB) is a full-time position responsible for supporting the Project Planning & Administration Department with a focus on supporting activities as they pertain the operational aspects of the set-up and management of the Data Safety Monitoring Boards and support of process improvements within multiple departments.


The Project Planning & Administration Department is responsible for supporting project execution inclusive of project resourcing, project scheduling and demand, portfolio management and overall support and quality of project management processes.

RESPONSIBILITIES:

Tasks may include but are not limited to:
 

  • Responsible for ensuring all operational aspects of the set-up and management of the Data Safety Monitoring Board (DSMB) Meetings are completed including;
    • Identification of study team members involved in the set-up of the DSMB
    • Communicates to the Sponsor the selection of DSMB members
    • Arrangement of the collection of CVs, financial disclosures, confidentially agreements for DSMB members
    • Creation, coordination, and distribution of meeting agendas, minutes, data and outputs for DSMB meetings, as required
    • Facilitation of DSMB meetings
    • Responsible for TMF filing of DSMB meeting materials
    • Support contracting and payments of DSMB members if applicable
  • Ensure project deliverables are met according to both Worldwide and Sponsor expectations
  • Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
  • Support process improvement within departments
  • Develop and maintain documents, tools, and forms related to Project Planning & Administration Office
  • Assist with review of Quality Management Document inclusive of SOPs, Work Instructions, and other department related documents, as required
  • Support Project Planning and Administration department with tasks as they pertain to quality initiatives, including but not limited to:
    • Meeting organization, preparation, conduct, and outputs
    • Assist with quality control checks and measures
  • Other responsibilities as assigned by manager

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

 
OTHER SKILLS AND ABILITIES:

  • Strong leadership and problem-solving skills
  • Working knowledge of clinical research, ICH, GCP, and FDA or EU directive regulations (as applicable)
  • Experience with process improvement initiatives
  • Strong interpersonal skills in a fast-paced and rapidly changing environment
  • Excellent written and verbal communication skills
  • Ability to manage escalations and resolve issues independently
  • Ability to work independently and professionally communicate with internal and external counterparts
  • Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
  • Ability to handle multiple tasks, including rapid response in generating new documents, forms, and tools
  • Strong organizational skills, especially around planning meetings
  • Strong attention to detail and communication nuances
  • Ability and willingness to work across multiple time zones
  • Advanced skills in MS Office applications including Microsoft Word, Excel, PowerPoint and Publisher. 
  • Excellent spoken and written English skills as well as fluency of the language of the country of location


REQUIREMENTS:
 



 

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