Clinical Research - Sr Specialist Global Site Service/ Sr. CRA/PM

A. Duties and Responsibilities: • Day to day supervision of GSS Staff to meet short term objectives across multiple sites; this includes but is not limited to prioritization of workload, reviewing document collection progress, addressing study specific questions, training and mentoring • Lead the delivery of site activation of allocated studies or programs to agreed timelines through frequent monitoring of the actual progress against planned project goals. • Assess impact of project scope and / or timeline changes on resource requirements, work flow priorities • Ensure compliance with document tracking information in the site information module of Trial Tracker • Ensure follow-up of projected IRB / IEC approvals to expedite site activation • Act as primary contact for clients and clinical operational project teams regarding GSS related project issues • Provide training and development of staff in Global Site Services processes and requirements • Assist where required with the collection, review, processing and tracking of regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP and ICH guidelines and the Investigator Package Plan • Perform review of study documents, including protocols and ICFs to ensure compliance with applicable standards and regulations • Create, or assist in creation, and review of Core English, Core Country and Site Specific patient informed consents for required elements to ensure quality of GSS output as applicable • Resolve more complex informed consent and contractual language issues by exercising advanced judgment when interacting with study sites or assisting team assigned team members • Assist with follow-up with investigative sites regarding document completion/submission; ensure escalation to GSS Manager or equivalent and / or client if timelines may be jeopardized • Liaise with Sponsor and Covance Regulatory regarding document submission requirements • Assess impact of study amendments on Informed Consent and other study documents and revise accordingly • Prepare applications to applicable IRB/IECs • Review & assess maintenance of central project files and investigative site files for compliance with Covance SOPs & GSS specific guidelines • Assume responsibility for the preparation and dissemination of documents according to the feasibility processes in place • Create surveys to probe “thought leaders” and experienced researchers-clinicians in the field for expert feedback • Assist in production, review and audit data tables and spreadsheets for feasibility assessments • Prepare internal feasibility reports by summarizing information obtained during previous feasibility assessments, historical Covance study experience, and Investigator self-reported data • Conduct follow-up calls/telephone interviews with Investigators/Study Coordinators to solicit in-depth information related to feasibility, obtain further detailed information regarding potential proposals, trends around medical practices and referral networks • Act as project team, Investigator Site and Sponsor point person for global feasibility studies as assigned: maintain open communication with global colleagues, provide feasibility study Investigator packet, collect data from appropriate regions and generate the formal report • Mentor other GSS team members in advanced feasibility tasks • Effectively manage multiple projects of varying levels of complexity within very short turnaround cycles • Directly manage day to day conduct with clients for stand alone feasibility activities and other feasibility activities as appropriate • Assist with preparation of materials for formal client/industry presentations and for internal training assignments • Perform other duties as assigned by management