Job Vacancy at PAREXEL

Job description

• Assist the PL to generate study/site specific forms and templates per SOPs, if required. Support PL to set up project specific requirements for investigator payments and tracker. Support PL to prepare, co-ordinate, attend and document internal and Sponsor Kick Off Meetings and investigator meetings. Support ongoing project meetings and when delegated, help to document meeting minutes. Record actions and outcomes of each meeting and follow-up with the appropriate team members. Prepare electronic site binders, if required. Arrange for printing of study case report forms, if required. Support the filing and quality control QC checks of project documents in PMED and wet ink files according to the CFMP. During Project Execution and Control. Review and regularly update RACI, SOP listings, SMP, systems (e.g., GXDB), PMP (all sections), patient recruitment plan, CFMP and project schedule with project progress, events, scope change, monitoring visits and reports, site changes and all associated tools and templates on a regular basis as agreed with the PL – track project progress and metrics per the PMP. Provide Sponsor/internal reports and metrics and compile/update presentations as needed. Support ongoing project meetings, when delegated, help to document meeting minutes, actions and outcomes, following up with team members where appropriate
• Support PL to manage project resources, requesting new resources and escalate issues to PL where needed and document and manage changes in project team members – keep team list up to date, update systems access, etc.Track and update PST, Changes in Scope and risk management: Work with PL, Project Financial Analyst and Portfolio Director to develop “what if” scenarios to ensure pro-active decisions and solutions.Manage central filing (including filing of wet ink document if applicable), access and conduct CF QC in PMED according to CFMP
• Communicate with the Sponsor regarding specific items/tasks as directed by the PL
• Manage process and track site investigator payments, (per the site contracts) using defined tools and systems: Ensure investigator information and payment details are entered in the CTMS (if applicable), administer investigator payments; track payments, ensure timely processing and secure all approvals as needed. Support project team when preparing for audits and regulatory inspections as needed. Assist the PL to update/generate study/site specific forms and templates per SOPs, if required. Coordinate Third Parties to answer queries, provide study updates, reports and trackers if required. During Project Closure: Perform final updates to SMP, trackers, RACI, PMP, CFMP, study schedule and all associated tools and templates and save as final version and file according to CFMP
• Close Out Systems as per Project Specific Systems Management Plan
• File all remaining project and non-project related documents per the CFMP
• Ensure that the PDF copies of CRFs are delivered to each site for retention in investigator site files if applicable. Perform final QC of CF and close out Central files per CFMP – support delivery of CF by PL to Sponsor and support internal archiving per the archiving manual/CFMP
• Support PL to request submission of all other outstanding costs (TPS invoices, investigator payments etc.) to the study finance personnel. Initiate closure of third party supplier contract (e.g., central lab, courier services).Request submission and finalization of all TIME and expenses from team
• Help to arrange and conduct final lessons learned meetings and update lessons learned database - document and communicate lessons learned

Qualifications

• Bachelor’s degree or equivalent in a scientific field (e.g., medical, nursing, science, clinical research) or
• Bachelor’s degree in Economic and Business Sciences with a least 2 years relevant experience in the CRO /Pharmaceutical industry