Clin Ops Lead - Sponsor Dedicated, Home Based in Italy

Employer
Syneos Health
Location
Italy (IT)
Salary
Upon Application
Closing date
25 Sep 2020

View more

Discipline
Clinical Research, Clinical Program Manager, Clinical Project Manager, Clinical Study Manager, Clinical Trials Manager / Administrator
Hours
Full Time
Contract Type
Permanent
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Here at Syneos Health we are looking for a Clinical Operations Lead to join our FSP team, working with a leading Pharma company. This role can be home based anywhere in Italy.


Why Syneos Health?

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.


This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, sponsor's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
For certain studies, the COL could be responsible for several countries in a cluster.

Responsibilities include, but are not limited to:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).

• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.

• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, sponsor's policies and procedures, quality standards and adverse event reporting requirements internally and externally.

o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.

o Performs Quality control visits as required.

• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration.

• Responsible for creating and executing a local risk management plan for assigned studies.

• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.

• Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate).

• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.

• Country POC for programmatically outsourced trials for assigned protocols.

• Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets).

• Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.

• As a customer-facing role, this position will build business relationships and represent the sponsor with investigators.

• Shares protocol-specific information and best practices across countries\clusters.  

 

 REQUIREMENTS:

• Bachelor’s degree in science (or comparable);

• 5-6 years of experience in clinical research;

• Clinical Trial Management experience would be preferable;

• CRA experience;

• Fluency in Italian and English.


We have a comprehensive benefits package and offer highly competitive remuneration.

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/


Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Syneos-header

Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 23,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit syneoshealth.com.

Please visit our Careers Hub on PharmiWeb.Jobs:www.pharmiweb.jobs/minisites/syneos-careers-hub/

Contact Us
  • Corporate Headquarters
  • 3201 Beechleaf Court
  • Morrisville
  • 27560
  • US
  • +1 919 844 7100
  • Mini-site: Syneos Health
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