La CRO CIRM cerca un Clinical Project Manager con esperienza

1. C.I.R.M. Consorzio Italiano per la Ricerca in Medicina
Istituto Villa Marelli – ASST Niguarda, Viale Zara 81-20159 Milano
Tel. +39.02.66825289/69900687 Fax +39.02.69900824
C. F. 96033070184 P.IVA 01764840185 REA MI-1683961 e-mail segreteria@cirm.net (PEC cirm@legalmail.it) - www.cirm.net
FS 550689
JOB DESCRIPTION CLINICAL PROJECT MANAGER
Job details : Clinical Project Manager
Report to: General Manager and Director of CRO
Employment Classification: full-time, office based
Brief company description: CIRM is a non-profit research consortium, created on 10 November 1997 and
composed of public and private partners (IRCCS, AO, institution) extended to associated partners of a
scientific and technological nature in the “life Science ".
CIRM works in translational research, clinical experimentation and high education.
The CIRM manages both European, national and regional projects financed by the PA, and on orders from
commercial companies. CIRM is a CRO accredited to AIFA.
Description of the position: the Clinical Project Manager (CPM) is responsible for managing the activities of
the CRO. The CPM manages the technical management aspects of Clinical Trials and research projects in
which clinical trials are planned. The CPM, in agreement with the Director General of CIRM, is responsible
for complying with the timing of the execution of the assigned activities, satisfying the regulatory
requirements in terms of timing, quality / scope and budget constraints.
Essential duties and responsibilities: The Clinical project manager must be able to:
• Proactively manage the operational aspects of the project, of the clinical trials, of the budget, of the
internal resources referring to it and of the external relations relating to the assigned projects.
• Update the General Director and the CRO Director on the progress of the activities, in relation to the
project plans, the budget and the management of the timelines in compliance with the quality standards.
• Provide Supervise and manage the process of starting clinical trials.
•Provide an overview of the management and archiving of documentation such as the Trial Master File
(TMF) and the electronic archive,
• Support the General Management in the finalization of the budget and in the agreements with the
Clinical Centers
• Support the General Management in selecting suppliers.
• Work proactively with the General Manager for the management of ongoing projects and support the
procedures necessary for the presentation of new projects.
• Acting in compliance with and developing corporate standard operating procedures (SOPs), operating in
compliance with ICH / GCP guidelines and regulatory requirements.

2. C.I.R.M. Consorzio Italiano per la Ricerca in Medicina
Istituto Villa Marelli – ASST Niguarda, Viale Zara 81-20159 Milano
Tel. +39.02.66825289/69900687 Fax +39.02.69900824
C. F. 96033070184 P.IVA 01764840185 REA MI-1683961 e-mail segreteria@cirm.net (PEC cirm@legalmail.it) - www.cirm.net
FS 550689
• Review and approve reports of CRA monitoring visits;
• ensure monitoring, follow-up and resolution of clinical center problems
• Monitor the quality of results and address quality problems with the Quality Assurance Manager
• Ensure that project-level study documentation is stored in the TMF in accordance with the company SOPs
and regulatory requirements, providing oversight to the clinical team
Education / Experience
The candidate must be in possession of:
• Scientific degree and at least 3 years experience in Clinical operations documented in the pharmaceutical,
biotechnology, medical devices or CRO sectors.
• Candidates with five or more years of experience in managing clinical projects with a sponsor or CRO are
preferred
• Experience in experimental studies initiated by IIS Investigator and initial phase (Phase I-II).
• The CRA certification, as per the decree of November 15, 2011, is considered an added value.
Knowledge, skills and abilities:
• Read, write and speak English fluently; excellent verbal and written communication skills
• Have in-depth knowledge of the concepts of clinical research, practices and FDA regulations
• of the ICH, GCP guidelines and related to the phases of drug development, clinical research and data
management methods.
• Possess a good general computer skills, of the office package, and web.
• Having skills of eCRF and EDC
Work environment: the following items are considered necessary skills:
• ability to organize and manage priorities in a small but structured team,
• ability to interact with team members, flexibility and availability to cover diversified responsibilities
required by the management of research projects
• Availability to travel in national and international territory to the extent that this is required by ongoing
activities

3. C.I.R.M. Consorzio Italiano per la Ricerca in Medicina
Istituto Villa Marelli – ASST Niguarda, Viale Zara 81-20159 Milano
Tel. +39.02.66825289/69900687 Fax +39.02.69900824
C. F. 96033070184 P.IVA 01764840185 REA MI-1683961 e-mail segreteria@cirm.net (PEC cirm@legalmail.it) - www.cirm.net
FS 550689
HOW TO APPLY
Please send you application to:
Anna Allodi
Direttore Generale
C.I.R.M. - Consorzio Italiano per la Ricerca in Medicina
Istituto Villa Marelli - AO Niguarda, Viale Zara, 81, 20159 MILANO
anna.allodi@cirm.net - http://www.cirm.net