Country Operations Management Intern
This is what you will do:
The Intern, Country Operations Management (ICOM) is a working student that joins the COM team to be trained and learn about the Clinical Research and pharmaceutical industry field while providing support to their colleagues, as needed.
The ICOM is accountable within their region (cluster) for supporting the COM team in the successful execution of study deliverables and the quality execution of high priority and / or complex protocol procedures through adherence to good clinical practices (GCP),evolving regulatory requirements, and ensuring quality and consistency in timely completion of study activities.
The ICOM may liaise with the Site Management Lead (SML) to attend oversight site visits (onsite or remote) with the purpose of learning and development as well as provide support if needed.
You will be responsible for:
Accountable For:
- Support the COM team in achieving quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation)
- Support the COM team in reporting of study-specific issues (including monitoring metrics) to the study team via the Study Lead Country Operations (SLCO).
- May support the CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party).
- May support in the negotiation of site study contracts and budgets for the studies at country level as requested by COM team.
- May support in review of local regulatory documentation and local regulatory activities.
- Provide support in remote and onsite monitoring activities for assigned studies
- Provide support in coordination of country level engagement activities.
- Provide support country calls with local study team and/or CRO, as applicable.
- Lead process improvement initiatives that supports the cluster goals
Responsible For:
- Support Meeting preparation (agendas, materials, … )
- Support Filing activities
- Provide other Administrative support to projects
- Ad hoc support study teams in site management during start up phase including but not limited to contract negotiation, EC/CA submissions matters, site initiation visits preparation administrative tasks and recruitment phase of the study.
- Ad hoc support of Clinical Monitoring activities, from documentation review (reports, metrics, etc) to onsite support (site documentation management, IP accountability support, SDR/SDR support to CRA, ….) for the assigned studies and communicate monitoring deficiencies to SML as applicable.
- Support SMLs in monitoring oversight tools maintenance.
- Timely and accurate responses to queries from the country team.
- May participate in meetings Medical Affairs to coordinate site feasibility.
- Support Inspection readiness activities at local level for assigned studies.
- Support the development and maintenance of project management tracking tools (e.g: CTMS, smartsheets, etc).
You will need to have:
- Good organizational skills and ability to deal with competing priorities.
- Effective communication skills (written, verbal and presentation).
- Creative thinker, curious and unafraid to ask questions.
- Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve.
- Proficient with MS Office Suite (Excel, Word and PowerPoint).
- Bachelor’s level degree or currently studying for, required.
We would prefer for you to have:
- Bachelor's Degree (or currently studying for) or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
We’ll keep you up-to-date
