Study Start-up Project Lead, Rome - FSP
Syneos Health
Home Based, ITA, GB
6 gg fa
source : PharmiWeb.com

Here at Syneos Health Italy, we are looking for Study Start-up Project Leads to join our FSP team, working fully outsourced to a leading Pharma company.

This role will be home / office based around the Rome area.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.RESPONSIBILITIES :

  • Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
  • Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Oversight of FCPA, DPS / OFAC, and maintenance of financial systems.

    Financial forecasting in conjunction with Director.

  • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations.
  • Interactions with IRB / IEC and Regulatory Authority for assigned protocols.

  • Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
  • Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs. Oversees Clinical Trial Assistants as applicable.

  • Coordinates and liaises with Project Manager, CTA, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
  • Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.

  • Oversight and coordination of local processes. Clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic / hard copy filing, archiving and retention requirements, and insurance process management.
  • Enters and updates country information in clinical and finance systems.

  • Has ownership, oversight and impact on local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
  • Working closely with the Director and local GCTO country operation to assess, prioritize and drive execution of specific clinical trials in order to support and manage the pipeline and local business needs to agreed timelines and budgets.
  • Required to in / directly influence investigators, external partners and country operations to adhere to budget targets and agreed payment timelines.

  • Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB / IECs and Regulatory Authorities in submission and approval related-interactions.
  • Through continual interaction with local clinical team / s successfully delivers clinical and financial contracts within fair market value.

  • Bachelor's Degree (or comparable) in Business Finance / Administration / Life Science or equivalent Health Care related experience;
  • 5-7 years clinical research experience;
  • Requires expertise of core clinical systems, tools and metrics;
  • Excellent English skills required;
  • Strong coordination and organizational skills required;
  • Requires skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up;
  • Able to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Director.
  • We have a comprehensive benefits package and offer highly competitive remuneration.#LI-VC1Disclaimer : 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.

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