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:
 

• Four-year college curriculum or university degree In lieu of degree, relevant skills or equivalent experience in life sciences, biotech or medical science
• At a minimum of 4-6 years’ experience in clinical research
• At a minimum of 4-6 years’ experience in project management and project management process
• Can demonstrate experience of successfully managing and/or leading multidisciplinary teams
• Prior experience in working Data Safety Monitoring Boards preferable
• Skill sets and proven performance equivalent to above