Medical Operations Clinical Study Associate Manager Lazio

Medical Operations Clinical Study Associate Manager
Roma
Lazio, Lazio

About AbbVie

For our Rome office we are searching for a Medical Operations Clinical Study Associate Manager with following responsibilities:

- To be responsible for the implementation and execution of assigned International Studies/Collaborative Researches (from now on defined Studies) in compliance with all applicable regulations, processes and procedures and with agreed parameters (timelines/cost)

- To support MO Sr. Clinical Study Manager for the implementation and execution of local assigned Studies/Collaborative Researches (from now on defined Studies) in compliance with all applicable regulations, processes and procedures and with agreed parameters (timelines/cost)

- To be responsible for definition and monitoring of resources needed for assigned Studies implementation and execution, including selection of external resources, as applicable

- Leader of the cross functional study team: for studies and Responsible for regular updates to the cross-functional team and stakeholders on study status;

- To support MO sr Clinical Study Manager in the development of the clinical study design and associated systems and documents, as applicable (for example: Informed consent forms, eCRFs, Management tools)

- To support MO sr Clinical Study Manager for the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie's processes and procedures and the applicable regulations

- Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies

- Proactively identify and address and/or escalate study related issues and opportunities for efficiency

- Decision maker on operational aspects of study execution.

Participates in innovation and process improvement initiatives.

- To be responsible for ensuring compliance to applicable national regulations related to legal and regulatory aspects for all assigned studies

Responsibilities include but are not limited to the following:

- To provide support to Evidence Solutions Manager and Medical Affairs in reviewing data analysis and statistical reports for assigned studies until Clinical Study Report finalization

- To collaborate with the Affiliate Pharmacovigilance Unit for the management of any Safety aspects related to the assigned clinical studies

- To contribute to the design and improvement of Medical Department systems and processes with the aim of ensuring best practice as well as compliance to all applicable regulations and Company procedures

- To undergo training relevant to the function, to be familiar and updated with the AbbVie local and international procedures relevant to the Job Description

**Qualifications

- Minimum 5 years clinical research experience, at least 2 years as Clinical Project Manager and at least 2 years' experience in clinical site monitoring (required).

- Minimum of 1 year working experience in pharmaceutical/biotechnological industry, in a scientific/medical role, within cross functional teams

- Ability to transform strategies into feasible and realistic actions

- Ability in leading, motivating, and coordinating cross functional team

- Strong experience in team and individual leading, managing and coaching and in developing talents and performance (minimum 3 years')

- Excellent knowledge of the health sector and of its development

- Effective management of the work in a matrix structure

- Knowledge of financial principles and processes

- English Language Knowledge, both written and spoken (mínimal Common European Framework level: C1)

**Travel

No

**Job Type

Experienced

**Schedule

Full-time

**Job Level Code

IC

**Equal Employment Opportunity