Here at Syneos Health Italy, we are looking for a Clinical Operations Specialist/ Clinical Trial Associate to work sponsor dedicated for one of our best partners in Oncology trials. The job location would be Rome.

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. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.

RESPONSIBILITIES:

• Trial and site administration:
   o Track (e.g. essential documents) and report (e.g. Safety Reports);
   o Ensure collation and distribution of study tools and documents;
   o Update clinical trial databases (CTMS) and trackers;
   o Clinical supply & non-clinical supply management, in collaboration with other country roles;
   o Manage Labeling requirements and coordinate/sign translation change request;

• Document management:
   o Prepare documents and correspondence;
   o Collate, distribute/ship, and archive clinical documents, e.g. eTMF;
   o Assist with eTMF reconciliation;
   o Execute eTMF Quality Control Plan;
   o Update manuals/documents (e.g., patient diaries, instructions);
   o Document proper destruction of clinical supplies;
   o Prepare Investigator trial file binders;
   o Obtain translations of documents;

• Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
  o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions;
  o Obtain, track and update study insurance certificates;
  o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions;
  o Publish study results for GCTO and RA where required per local legislation;

• Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
 o Develop, control, update and close-out country and site budgets;
 o Develop, negotiate, approve and maintain contracts (e.g. CTRAs);
 o Track and report contract negotiations;
 o Update and maintain contract templates (in cooperation with Legal Department);
 o Calculate and execute payments (to investigators, vendors, grants);
 o Ensure adherence to financial and compliance procedures;
 o Monitor and track adherence and disclosures;
 o Maintain tracking tools;

• Meeting Planning:
 o Organize meetings (create & track study memos/letters/protocols);
 o Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable);

Qualifications 

 • Minimum 1 - 2 years in Clinical Research or relevant healthcare experience;

• Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience;

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills;

• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines;

• Hands on knowledge of Good Documentation Practices;

• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required;

• ICH-GCP Knowledge appropriate to role;

• Excellent negotiation skills in finance area.

We offer a highly competitive remuneration and package.

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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.