As a Clinical Trial Manager you will be leading the Local Study Team(s) (LSTs) at country
level to deliver committed components of clinical studies according to agreed resources, budget and
timelines complying with Procedural Documents and international guidelines such as ICH-GCP
as well as relevant local regulations.
In addition to leading LST(s), as the CTM you may perform site
monitoring as needed to support the flexible capacity model.

Key responsibilities

• Has the overall responsibility for the study commitments within the country and for

timely delivery of data to required quality.

• Leads Local Study Team consisting of CRAs, CTAs, and Study Start-up Specialists for

assigned study/studies

• Leads and optimizes the performance of the Local Study Team(s) at country level

ensuring compliance with SOPs, ICH-GCP and local regulations.

• Ensures, as required, that clinical and operational feasibility assessment of potential

studies is performed to the highest quality.

• Coordinates the site selection process by identifying potential sites/investigators,

performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits
to evaluate suitability and quality risks.

• Ensures timely preparation of country financial Study Management Agreement (fSMA)

and maintains accurate study budget in the clinical studies financial system by regular
checks of the system and financial reports