Clinical Trial Manager

1 semana atrás

Braga, Braga, Portugal Icon Tempo inteiro

As a Clinical Trial Manager sponsor dedicated you will be primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, sponsor's policies and procedures, quality standards and adverse event reporting requirements internally and externally.

For certain studies, the CTM could be responsible for several countries in a cluster.
What you will be doing:

  • Main Point of Contact (POC) for assigned protocols and link between Country Operations
and clinical trial team (CTT).

  • Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country
commitments from feasibility and site selection, recruitment, execution and close out.

  • Accountable for performance for assigned protocols in a country in compliance with
ICH/GCP and country regulations, Sponsor's policies and procedures, quality standards and
adverse event reporting requirements internally and externally.
o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as
needed.
o Performs Quality control visits as required

  • Leads local study teams to high performance: trains in the protocol other local roles, closely
collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration

  • Responsible for creating and executing a local risk management plan for assigned studies
  • Ensures compliance with CTMS, eTMF and other key systems in assigned studies
  • Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as
appropriate)

  • Responsible for collaboration with functional outsourcing vendors, investigators, other
external partners in assigned studies

  • Country POC for programmatically outsourced trials for assigned protocols.
  • Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)
  • Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align
on key decisions in his/her studies. GHH to be consulted as needed.

  • As a customer-facing role, this position will build business relationships and represent the sponsor with investigators
  • Shares protocol-specific information and best practices across countries clusters

You are:

  • Knowledge in Project Management and site management.
  • Strong organizational skills with demonstrated success required.
  • Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD
  • Requires strong understanding of local regulatory environment
  • Strong scientific and clinical research knowledge is required
  • Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
  • Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
  • Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
  • Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
  • Strategic thinking Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.

In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people.

That's why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.

All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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