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Clinical Operations Lead

Employer
i-Pharm Consulting
Location
Rome (province), Italy, Rome / Italy, Milan / Italy
Salary
Negotiable
Start date
11 Nov 2022
Closing date
25 Nov 2022

View more

Discipline
Clinical Research, Clinical Research Associate
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management
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Job Details

Job Overview:


Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions:


* Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
* Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
* Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
* Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
* Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
* Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
* Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
* Collaborate and liaise with study team members for project execution support as appropriate.
* If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
* If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications:


* High School Diploma or equivalent Degree in scientific discipline or health care preferred.

* Must be in possession of CRA Certification according to Ministerial Decree dated 15/11/2011.
* Requires at least 1 year of year of on-site monitoring experience.
* Equivalent combination of education, training and experience may be accepted in lieu of degree.
* Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
* i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
* Good therapeutic and protocol knowledge as provided in company training.
* Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
* Written and verbal communication skills including good command of English language.
* Organizational and problem-solving skills.
* Effective time and financial management skills.
* Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Find Us
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
GB
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