Manager, Data Safety & Monitoring Board (DSMB) US/Mexico

Requisition Number: 5624

Position Title: Manager, Data Safety & Monitoring Board (DSMB)

External Description:

Who we are 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. 

We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. 

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.  

What you will do as a Manager, Data Safety & Monitoring Board (DSMB)

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.

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:

• 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 the pertain to quality initiatives, including but not limited to:
  • Meeting organization, preparation, conduct, and outputs
  • Assist with quality control checks and measures

 
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 4-6 years’ experience in clinical research
• At a minimum 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

Why Worldwide 
 

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.   

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers! 

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Employment Type: Regular

Community / Marketing Title: Manager, Data Safety & Monitoring Board (DSMB) US/Mexico

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.