Senior Manager, Project Management Country - Sao Paulo, Brasil - Alexion Pharmaceuticals,Inc.

Alexion Pharmaceuticals,Inc.
Alexion Pharmaceuticals,Inc.
Empresa verificada
Sao Paulo, Brasil

há 1 mês

Ana Silva

Postado por:

Ana Silva

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Descrição

This is what you will do:

The Project Manager Country Operations (PMCO) is accountable within their region for the successful execution of study deliverables and the quality execution of protocol procedures through adherence to good clinical practices (GCP),evolving regulatory requirements, and ensuring quality and consistency in timely completion of monitoring activities.

The PMCO is accountable for coordinating rapid start up activities across assigned countries in collaboration with the CRO.

The PMCO will also drive adherence to timelines and milestones of study goals as well as identifying, managing and communicating risks to the study team and preparing mitigation plans.


The PMCO will ensure that the CRO assigned, dedicated, FSP or in house CRA monitoring activities at study sites results in the effective identification and problem solving of issues.

The PMCO will work with the CRO to revise study specific country plans and timelines.

They will be accountable for ensuring study design and timelines are achievable in the local environment and meeting performance expectations.

The PMCO will also ensure that studies assigned in the country are appropriately resourced.


The PMCO will also ensure that the CRO understands complex protocol processes and procedures and may support CRA protocol-specific training.


The PMCO will coordinate with the Site Management Lead (SML) attendance at oversight site visits (onsite or remote) based on quality signals observed in the assigned studies, together with the CRO, dedicated CRA, FSP CRA or in house CRA as applicable or with Global Medical Affairs personnel for Engagement Visits.


You will be responsible for:


  • Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies).
  • Proactive reporting of studyspecific issues (including monitoring metrics) to the study team via the Study Lead Country Operations (SLCO).
  • Quality of monitoring oversight in the country for assigned study(ies).
  • Meeting recruitment targets for assigned study(ies).
  • CDA delivery and negotiation (based on preapproved parameters and regardless of executory party).
  • ICF customization at country/site level for the assigned studies.
  • Negotiation of site study contracts and budgets for the assigned studies at country level.
  • Review of local regulatory documentation and oversight of local regulatory activities.
  • Relationship management with the national coordinating investigator as applicable and coordination of country level engagement activities.
  • Scheduling and leading effective country calls with local study team and/or CRO, as applicable.
  • Leading recruitment discussions at local level for the assigned trials.
  • Timely and accurate responses to queries from the study team.
  • Proposing potential investigator sites in collaboration with other country functions such as SML, HCO or Medical Affairs.
  • Working with key stakeholders to coordinate site feasibility.
  • Oversight of EC/CA submissions and facilitate resolution of queries.
  • Reviewing and approving site selection visit reports (HCO accountable for selection).
  • Coordination of study specific training of CRAs for assigned trials.
  • Oversight of dedicated or FSP CRAs on assigned studies.
  • Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies.
  • Inspection readiness activities coordination at local level for assigned studies.
  • Relationship management with sites.
  • Providing feedback to Internal and External Stakeholders as appropriate according to the relevant plans (i

e:
communication plans).

  • Developing and maintaining project management tracking tools (e

g:
CTMS, smartsheets, etc).

  • Driving quality efforts to proactively identify and manage risks to study quality.
  • Supporting CRAs onboarding, particularly for study specific trainings.
  • For the assigned trials PMCO should assess CRA resourcing needs. HCO keeps accountability for resourcing at country level and needs to be looped in.

You will need to have:


  • Proven experience in the oversight and delivery of operational aspects of all stages of of clinical trial process.
  • Solid knowledge of clinical development processes.
  • Ability to lead, troubleshoot and influence for quality and delivery.
  • A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected.
  • Proven experience in effectively communicating with site staff including and including KOLs and thought leaders.
  • Comprehensive and current regulatory knowledge, including GCP.
  • Experience conducting GCP or other training is a plus.
  • Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods).
  • Good organizational skills and ability to deal with competing priorities.
  • Effective communication skills (written, verbal and presentation
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