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Job Description
Who we are:
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
Why Worldwide:
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What a DSMB does at Worldwide:
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.
What you will do:
What you will bring to the role:
Your Experience:
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
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Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
Why Worldwide:
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What a DSMB does at Worldwide:
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.
What you will do:
- 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
- Assist with review of Quality Management Document inclusive of SOPs, Work Instructions, and other department related documents, as required
What you will bring to the role:
- 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
Your Experience:
- 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
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
#LI-FD1
#LI-remote