PE Global
Medical Affairs Specialist
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Medical Affairs Co-Ordinator
PE Global are currently recruiting for a Medical Affairs Co-Ordinator for a 12 month contract role with a leading multinational Pharma client, based in Basingstoke. The candidate must be in the office a minimum of 3 days per week.
The purpose of the Investigator Initiated Trials (IIT) Associate role in the International Business Unit (IBU) is responsible for the IBU IIR (Investigator Initiated Research) program coordination with appropriate business partners to ensure the IBU IIR program is managed effectively and in compliance with Global and local policies. The associate is accountable to monitor and control the performance of the ongoing IIT studies utilizing required tools and techniques per IIT procedure in a cluster of countries.
Responsibilities
- IBU Primary point of contact for affiliates and business partners from other functions regarding ongoing externally sponsored research studies.
- Negotiate and obtain fully executed contracts as well as contract amendments and track trial compliance to these contracts.
- Ensure that costs, timeline, scope, and risk management process are in place to monitor and measure performance of the overall IBU IIR program utilizing required tool and techniques per IIT standard and procedure for ongoing IITs.
- Forecast timelines and financial metrics by liaising with the affiliates and/or Investigator to obtain the latest financial and milestone/enrolment data (plan and actuals) during the maintenance phase of the study.
- Create and maintain inspection-readiness at all times (e.g. binders, IIR Portal, electronic files, etc.).
- Manage the tracking IIRs during its lifetime (from Protocol Approval to Study Close out), including activities such as site close-out activities, final deliverables received, manuscripts/publications review, close out the study in all appropriate areas (i.e., sharepoint, IIR portal etc.).
- Collaborate and ensure ongoing adequate and appropriate communication with all relevant functions and investigators throughout the lifecycle of the studies to ensure:
- Milestone tracking
- Enrollment updates
- Finance support
- Drug supply management
- Develop and implement a team study escalation plan when necessary to ensure study adherence to agreed milestones and ensure effective and accurate communication with the affiliates on key decisions/results.
- Participate, coordinate, and facilitate operational meetings with external investigators.
- Oversight of clinical supply requests, feasibility, and forecasting.
- Ensure adherence to our medical and quality procedures(s).
- Communicate/follow up with IBU IIR team leader during study maintenance (e.g. study milestone tracking, quarterly updates, drug shipments, escalation process, payment coordination if applicable, etc.).
- Manage study through final deliverables ensuring, together with IIT Coordinator that any final reports/publications are submitted to Global IIR Review, final close out documents are received and archived, POs are closed, and all tracking areas are updated/closed out with final deliverable dates (i.e. sharepoints, IIR portal, etc).
- Ensure IIR Portal is updated consistently and accurately for inspection readiness.
- Ensure Investigator site regulatory readiness is in place prior to initial IP shipment.
- Collate and provide applicable regulatory documents to investigator for ERB/CA (competent authority) submission.
- Initiate any budget change, agreement term changes, or amendments throughout the study.
- Maintain the IBU IIR tools (e.g. IIR Portal) up to date with the appropriate documentation.
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Requirements
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- Bachelor’s degree preferably in a scientific or health related field or two years clinical research experience.
- Prior experience of clinical trial or study management in a pharmaceutical, biotech or CRO setting, for example in a Medical Affairs associate or study coordinator role would be beneficial.
- Previous affiliate and/or finance experience such as processing of invoices, PO set up.
- Contract creation and negotiation experience.
- Excellent writing, editing, and communication skills, both oral and written.
- Previous experience with cross-functional/cross countries teams or projects.
- Demonstrate problem-solving and project management abilities.
- Strong self-management and organizational skills.
- Ability to work with customers to clearly define and prioritize tasks.
Desirable
- Medical background/experience preferred.
- Understanding of the clinical drug development process.
- Knowledge of regulations and guidelines that apply to the conduct of medical research.
- Working knowledge of medical terminology.
- Strong knowledge of regulations and guidelines that apply to the conduct of medical research.
- Proficiency in use of Project Management tool such as CTMS, Excel, risk assessments.
Interested candidates should submit an updated CV.
Please note our client cannot assist with any visa sponsorship, and candidates must have the correct visa to live and work in UK
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