Manager, Safety Monitoring Committees

Location: United States

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Requisition Number: 7738

Position Title: Manager, Safety Monitoring Committees

External 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!

 

 

SUMMARY:  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)

 

 

RESPONSIBILITIES:

Tasks may include but are not limited to:

•    Serve as primary point of contact with client as well as internal team to ensure consistency, compliance and quality across projects for committee tasks

•    Responsible for ensuring all operational aspects of the set-up and management of the Committees are completed including.

o    Identification of project team members involved in the set-up of the Committees

o    Communicates to the Sponsor the selection of Committee members

o    Arrangement of the collection of CVs, financial disclosures, confidentially agreements for Committee members

o    Creation or review of Committee charter 

o    Creation, coordination and distribution of meeting agendas, minutes, data, and outputs for Committee meetings, as required

o    Scheduling and facilitation of meetings, inclusive of Open, Closed Sessions and Concluding open sessions

o    Responsible for oversight of TMF filing of Committee meeting materials

o    Support contracting and payments of Committee members if applicable

•    Ensure project deliverables are met according to both Worldwide and Sponsor expectations

•    Ensures all required restricted access folders or portals are set up as per Committee Charter specifications

•    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 

•    Liaison between the clinical project team, Sponsor, and committee members

•    Develop and maintain positive relationships both internal and external to projects, including Sponsors, team members, and committee members.

•    May serve in a line manager capacity with direct report depending on business needs

o    Provide direct supervision of assigned staff and projects ensuring:

  • All activities are performed to applicable regulations and process
  • Work is performed according to the budgeted scope of work
  • Work is performed within applicable timelines and according to quality standards

o    Provide guidance and coaching to direct reports and supporting roles

o    Escalate any issues or related to projects or staff conduct

•    Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects

•    Support process improvement within department

•    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)

•    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 

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 with Safety Monitoring Committees preferable

•    Skill sets and proven performance equivalent to above

 

 

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

 

 

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/careersFor more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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Employment Type: Regular

Community / Marketing Title: Manager, Safety Monitoring Committees

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.

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© Worldwide Clinical Trials 2023

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.