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Country Operations Management Intern

Country Operations Management Intern

Alexion PharmaceuticalsTurkey,Istanbul
15 days ago
Job description

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.
  • Date Posted

    28-May-2025

    Closing Date

    30-Tem-2025

    Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

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    Management • Turkey,Istanbul

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