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Junior clinical operations manager

For our office in Milano we are looking for a Junior Clinical Operations Manager.

The Junior Clinical Project Manager will be responsible for the set up and progress of a clinical trial/observational study/special program in his/her own country or in the assigned countries in the South Europe & Italy Cluster, ensuring compliance with Dompé Group quality standards and regulations in force, the forecasted timelines, milestones and budget.

PRINCIPALI AREE DI RESPONSABILITÀ

  • In support to the Senior PM Ensures the selection, management and oversight of the Contract Research Organization.
  • Is accountable for set-up and progress of the study according to the company standards and regulation in force and ensures that committed targets and timelines are met at all steps and until study completion.
  • Collaborates with the local Medical Department and Site Engagement Manager to identify potential investigators to be introduced in the clinical network of Dompé.
  • Supports study feasibility/site selection and country patient commitments in collaboration with the CRO and internal Medical team. Collects and manages input to the study protocol and operational aspects of the study, participates in the planning of Investigator Meetings.
  • Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required, in collaboration with the CRO. Works with local Drug Supply Management. Ensures IMP is available to commence and complete assigned trial/assigned trial sites.
  • Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country/Cluster personnel. Drives the conduct of the study, tracks status, maintains study level reporting systems, detects issues, oversees forecasts, progress, and mitigation plans, to ensure all study operational aspects are on track. Ensures recruitment targets are met, performs monitoring oversight and reviews enrolment at the site level including responsibility for approval of enrolling above site targets. Is responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan.
  • Ensures high quality management of the study: oversees CRO clinical team activities to achieve study timelines and quality execution, proposing and implementing corrective actions where appropriate, according to Dompé standards and local and international regulations.
  • In support to the Sr. Clinical Operations Manager monitors the status of the trial budget and contract negotiations.
  • In cooperation with other applicable corporate functions contributes to the drafting and update of the relevant SOPs.
  • Supervises the study documentation archiving process of the Clinical Trial Master File (CTMF)

REQUISITI

  • Bachelor Degree ;
  • A minimum of 2-3 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in clinical trial management and monitoring (e.g., clinical project manager, study coordinator, clinical research associate) ;
  • Proven track record of success on cross-functional projects in a global environment.
  • Competent in written and oral English
  • Excellent interpersonal, verbal and written communication skills
  • Customer orientation and ability to work well with colleagues within and outside clinical development
  • Scientific and technical knowledge:
  • GCP and regulatory environment;
  • Knowledge of GCP/ICH phase I-IV clinical trials and observational studies;
  • Medical knowledge and research expertise;
  • Excellent team leadership skills;
  • Ability to motivate both individually and collectively;
  • Excellent problem-solving capability through early identification;
  • Demonstrate, appreciation and understanding of finance and budgeting issues;
  • Excellent computer literacy;
Degrees of interest: Pharmaceutical, Biotechnology, and/or CRO industry