The Medical Affairs - Delivery Unit, Lead, Trial Delivery Manager (TDM) is responsible for the execution of (Investigator Initiated Studies) study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities. The TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews and local challenges that could impact overall study delivery. The TDM might however have responsibilities cross trial types (IIS, collaborative, CSS, etc) within different Therapeutic Areas, in a local, regional, or global setting depending on the business need.
* Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product (IMP) related documentation).
* Manage vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight.
* Accountable for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).
* Support development of program-level compound training, collaborating with Clinical / CTL&D / Medical writing.
* Provide input into trial level operational strategies.
* Resolve trial-related issues and mitigate trial-related risks.
* Participate in process improvement activities at a trial, compound & cross-DU level, as needed.
* Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
* Mentor & support onboarding of new team members, particularly those in Trial Management.
* Education and Experience Requirements
* BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.
* Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage multiple aspects of execution of a clinical trial.
* 2-3 years’ experience supporting global clinical trials.
* Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
* Experience leading without authority and in muti-functional matrixed and global environments.
* Excellent decision-making, analytical and strong financial management skills are essential to this position.
* Operate and execute with limited supervision. Experience mentoring / coaching others.
* Ability to support and participate in the hiring, training, development, and evaluation of staff on a regular basis.
* Strong project planning / management, communication and presentation skills are required.
* Knowledge of the Italian language is a must.
* Knowledge of the Italian HA and / or clinical trial legislations are a plus.
* Travel up to 15-20% of the time, defined by business needs.
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