Clinical Project Manager

Talent Source; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading clinical research organization in Milan is seeking an experienced Clinical Project Manager to oversee a Phase III onco-haematology study. Responsibilities include managing study delivery and compliance with regulations. The ideal candidate has a degree in biological sciences or pharmacy and substantial experience in Clinical Research. This full-time position offers meal vouchers and career opportunities.

Servizi

Meal vouchers

Mobile phone if requested

Dedicated Line Manager

Monthly meetings with line manager

Career opportunities

Competenze

• Substantial experience in Clinical Research including previous Global Study Management experience.

Mansioni

• Accountable for study execution and management.
• Tracks Regulatory submissions with the medical team.
• Ensures adherence to Good Clinical Practice.

Conoscenze

Competent in written and oral English

Excellent interpersonal, verbal and written communication skills

Client focused approach to work

Excellent team leadership skills

Ability to motivate both individually and collectively

Excellent problem solving capability

Understanding of finance and budgeting issues

Excellent computer literacy

Formazione

Degree in biological sciences, pharmacy, or health related discipline

Descrizione del lavoro

Overview

Location: Milan, Italy - office based

Schedule: Full-Time, Permanent

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE) is searching for a Clinical Project Manager to join one of our partner companies - an Italian pharmaceutical company, based in Milan. Scope of the role includes overseeing a large Phase III onco-haematology study and coordinating the operational aspects and proper conduct of a clinical study, including compliance with ICH / GCP, Client policies and Standard Operating Procedures.

Responsibilities

• Accountable for study execution, tracking and management of study delivery
• May manage feasibility
• Tracks Regulatory and EC submissions, with medical team
• Maintains the global study budget, ensuring cost effectiveness and addressing and escalate issues as appropriate
• Ensures set up and maintenance of all systems in order to plan and implement the study and track progress
• Ensures appropriate clinical trial supply strategy is implemented and managed
• Develops recruitment plan, manages risk, monitors progress and implements contingencies as required
• Ensures efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness / integrity of data
• Ensures adherence to Good Clinical Practice and all applicable local and international regulations
• Ensures for timely delivery of scientifically and operationally robust study documents
• Ensures development, review, finalisation and delivery of high quality key clinical study documents in order to meet study timelines
• Ensures accurate maintenance and archiving of study records
• Ensures global feasibility of site contractual agreements
• Accountable for site and monitor training in operational aspects of the study
• Ensures monitoring and site personnel are familiar with all study-specific processes, procedures and systems and that training is adequately documented. Manages CRAs at the clinical level
• Ensures continuous direct contact with in-country personnel to provide ongoing operational support
• Accountable for study related communications and for resolution or escalation of operational issues

Education and Experience

• Educated to degree level (biological sciences, pharmacy or other health related discipline preferred)
• Substantial experience in Clinical Research including previous Global Study Management experience

Skills

• Competent in written and oral English
• Excellent interpersonal, verbal and written communication skills
• Client focused approach to work
• 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

Benefits

• Meal vouchers
• Mobile phone if requested by the Line Manager
• Dedicated Line Manager
• Monthly meetings with line manager
• Full performance and development process with end of year reviews
• Team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

Application Process

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whils