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 3,500+ 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.
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 Manager, Safety Monitoring Committees Dept Does At Worldwide
The Manager, Safety Monitoring Committees is a full-time position responsible for managing activities as they pertain the operational aspects of the set-up and management of the Safety Monitoring Committees, inclusive of Data Safety Monitoring Boards (DSMB), Data Monitoring Committees (DMC), Safety Review Committees (SRC), Independent Review Committees (IRC) or Endpoint Adjudication Committees (EAC)
What You Will Do
- Responsible for ensuring all operational aspects of the set-up and management of the Committees are completed including:
- Identification of project team members involved in the set-up of the committees
- Communicates to the Sponsor the selection of Committee members
- Arrangement of the collection of CVs, financial disclosures, confidentially agreements for Committee members
- Creation or review of Committee charter
- Creation, coordination and distribution of meeting agendas, minutes, data, and outputs for Committee meetings, as required
- Scheduling and facilitation of meetings, inclusive of Open, Closed Sessions and Concluding open sessions
- Responsible for oversight of TMF filing of Committee meeting materials
- Support contracting and payments of Committee members if applicable
- Ensure project deliverables are met according to both Worldwide and Sponsor expectations
- Oversee audits and inspections for assigned projects and participating as required. Liaise with Quality Assurance individuals
- Support Business Development with budget reviews and bid defense meetings, as required
What You Will Bring To The Role
- Strong leadership and problem-solving skills
- Strong interpersonal skills in a fast-paced and rapidly changing environment
- Excellent written and verbal communication skill
- Ability to handle multiple tasks, including rapid response in generating new documents, forms and tools
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 with Safety Monitoring Committees 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 Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
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 know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. 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
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