The Data Monitoring Committee Specialist will be part of a team of specialized trained staff within the dedicated Data Monitoring Committee (DMC) Unit. This dedicated unit will manage or support all DMCs contracted to PRA. The DMC specialist will be responsible for providing administrative, facilitation and project management support to the DMC component of assigned studies. As this role will be an unblinded
position, the DMC specialists within this unit will have no role (other than in relation to the DMC) with ongoing blinded studies.
- Provides general administrative support to the DMC and IRS as needed including:
- Filing all DMC member documents in the TMF including: CVs, fully executed confidentiality agreements, fully executed consulting agreements, signed conflict of interest statements and documentation of client approval of all DMC members
- Scheduling and arranging meetings (e.g., scheduling conference rooms, coordinating logistics with meeting planning vendor).
- Drafting and finalizing agendas for all DMC meetings
- Drafting minutes of Face-to- Face meetings and DMC teleconferences (IRS to review/approve before distribution)
- Ensures all required restricted access folders/portal are set up as per DMC Charter specifications
- Arranges client review/roundtable for review of DMC documents
- Liaise with meeting planning vendor to coordinate and finalize slides for face to face meeting requirements
- Compiles data packages in line with any publishing requirements
- Following approval from the IRS, provides all documents (tables ,figures, listings, executive reports,etc) to DMC members and ensures correct (secure) filing
- Ensures the DMC recommendation is received from the DMC chairperson and forwarded to client and project manager/director
- Receives and forwards DMC members invoices for internal approval & payment
- Draft and send DMC members disbandment letter following approval from the IRS
- Has clear understanding of filing requirements for DMC documentation and ensures eTMF is kept up-to-date.
- Oversees activities with internal departments, external business partners, and other external vendors
Well organised, high attention and enjoy a highly visible role
- An undergraduate degree or its international equivalent in business or health sciences from an accredited institution, or equivalent work experience.
- Excellent written and oral communication skills
- Read, write and speak fluent English.
- Experience in the preparation of meeting minutes.
- Experience with Microsoft Windows, word processing and spreadsheet software.
- Experience in meeting facilitation and/or DMC management
- Experience in clinical informatics tasks
- Demonstrated interpersonal skills
- Ability to work with highly detailed information independently
- Proven history of successful interaction with internal clients and relations departments in a detail oriented setting.
This role will involve 30-40% travel for setting up DMC kick-off meetings
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.